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Review Panel
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Review Panel
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Review Panel
Miscellaneous
Miscellaneous
Subpart B—Cardiovascular Diagnostic Devices
CFR Sub-Part
Subpart B—Diagnostic Devices
CFR Sub-Part
Subpart C—Cardiovascular Monitoring Devices
CFR Sub-Part
Subpart C—General Hospital and Personal Use Monitoring Devices
CFR Sub-Part
Subpart D—Pathology Instrumentation and Accessories
CFR Sub-Part
Subpart D—Prosthetic Devices
CFR Sub-Part
Subpart E—Surgical Devices
CFR Sub-Part
Subpart F—General Hospital and Personal Use Therapeutic Devices
CFR Sub-Part
BRZ
Set, Blood Transfusion
2
Product Code
BWJ
Locator, Acupuncture Point
2
Product Code
CAK
Microfilter, Blood Transfusion
2
Product Code
DWL
Stocking, Medical Support (To Prevent Pooling Of Blood In Legs)
2
Product Code
FMF
Syringe, Piston
2
Product Code
FMG
Stopcock, I.V. Set
2
Product Code
FMI
Needle, Hypodermic, Single Lumen
2
Product Code
FMS
Bed, Pediatric Open Hospital
2
Product Code
FMT
Warmer, Infant Radiant
2
Product Code
FMZ
Incubator, Neonatal
2
Product Code
FNG
Lift, Patient, Ac-Powered
2
Product Code
FNJ
Bed, Manual
1
Product Code
FNK
Bed, Hydraulic, Adjustable Hospital
1
Product Code
FNL
Bed, Ac-Powered Adjustable Hospital
2
Product Code
FNM
Mattress, Air Flotation, Alternating Pressure
2
Product Code
FNN
Nipple, Lambs Feeding
1
Product Code
FOD
Device, Occlusion, Umbilical
1
Product Code
FOH
Mattress, Water, Temperature Regulated
1
Product Code
FOK
Pad, Neonatal Eye
1
Product Code
FOS
Catheter, Umbilical Artery
2
Product Code
FOZ
Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
2
Product Code
FPA
Set, Administration, Intravascular
2
Product Code
FPB
Filter, Infusion Line
2
Product Code
FPK
Tubing, Fluid Delivery
2
Product Code
FPL
Incubator, Neonatal Transport
2
Product Code
FQH
Lavage, Jet
2
Product Code
FQJ
Support, Scrotal, Therapeutic
1
Product Code
FQK
Binder, Perineal
1
Product Code
FQL
Stocking, Medical Support (For General Medical Purposes)
1
Product Code
FQM
Bandage, Elastic
1
Product Code
FRF
Cleaner, Air, Medical Recirculating
2
Product Code
FRL
Fiber, Medical, Absorbent
1
Product Code
FRN
Pump, Infusion
2
Product Code
K
24
2115
Plum Duo™ Precision IV Pump
2
Cleared 510(K)
K
24
2114
Plum Solo™ Precision IV Pump
2
Cleared 510(K)
K
25
0357
RemunityPRO™ Pump for Remodulin® (treprostinil) Injection
2
Cleared 510(K)
K
24
1736
Remunity 2.0 Pump for Remodulin (treprostinil) Injection
2
Cleared 510(K)
K
24
2735
Belmont Rapid Infuser, RI-2 (Rapid Infuser RI-2, 1000 ml/min); Belmont Rapid Infuser, RI-2 (Rapid Infuser RI-2, 750 ml/min)
2
Cleared 510(K)
K
24
2660
Curlin 8000 Ambulatory Infusion System; Enterprise Solution (ES) Software; Curlin 380-series Administration Sets
2
Cleared 510(K)
K
24
2390
Novum IQ Syringe Pump (40800BAXUS)
2
Cleared 510(K)
K
23
2793
Curlin 8000 Ambulatory Infusion System; Enterprise Solution (ES) Software; Curlin 380-Series Adminstration Sets
2
Cleared 510(K)
K
21
1122
Novum IQ Large Volume Pump
2
Cleared 510(K)
K
23
1918
Freedom60 Infusion Pump; High-Flo Subcutaneous Needle Sets; Precision Flow Rate Tubing; High-Flo Super26 Subcutaneous Needle Sets; Freedom60 Pre-Filled Syringe Adapter
2
Cleared 510(K)
K
23
0083
SAFIRA
2
Cleared 510(K)
K
22
3607
Plum Duo™ Infusion System
2
Cleared 510(K)
K
21
1218
BD Alaris System with Guardrails Suite MX v12.1.2
2
Cleared 510(K)
K
23
0041
Spectrum IQ Infusion System with Dose IQ Safety Software
2
Cleared 510(K)
K
23
0022
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library
2
Cleared 510(K)
K
21
3744
Avoset Infusion Pump System
2
Cleared 510(K)
K
22
2048
Spectrum IQ Infusion System with Dose IQ Safety Software
2
Cleared 510(K)
K
21
1125
Novum IQ Syringe Pump
2
Cleared 510(K)
K
22
0417
Spectrum IQ Infusion System with Dose IQ Safety Software
2
Cleared 510(K)
K
21
4045
FreedomEdge Syringe Infusion System
2
Cleared 510(K)
K
21
0073
Agilia VP Infusion System, Agilia VP MC WIFI Infusion Pump, Volumat Lines Administration Sets, Agilia Link, Agilia Duo
2
Cleared 510(K)
K
21
0074
Agilia SP Infusion System, Agilia SP MC WIFI Infusion Pump, Agilia Link, Agilia Duo, Agilia USB Cable
2
Cleared 510(K)
K
20
0176
FREEDOM Integrated Syringe Infusion System
2
Cleared 510(K)
K
21
1206
FreedomEdge(R) Syringe Infusion System
2
Cleared 510(K)
K
19
2860
Sapphire Infusion Pump, Sapphire administration sets
2
Cleared 510(K)
K
18
3311
Ivenix Infusion System (IIS)
2
Cleared 510(K)
K
19
0182
Unity Subcutaneous Delivery System for Remodulin
2
Cleared 510(K)
K
17
2653
Power Infuser
2
Cleared 510(K)
K
17
2831
Perfusor® Space Syringe Infusion Pump System
2
Cleared 510(K)
K
17
3084
Spectrum IQ Infusion System, Dose IQ Safety Software
2
Cleared 510(K)
K
16
2613
Integrated Catch-up Freedom Syringe Driver Infusion System
2
Cleared 510(K)
K
16
1469
Plum 360(TM) Infusion System with MedNet/ Smart Card Plug and Play Module
2
Cleared 510(K)
K
16
1667
Sapphire Infusion Pump
2
Cleared 510(K)
K
14
3369
MRidium 3860+ MRI infusion Pump/ Monitoring System
2
Cleared 510(K)
K
15
3599
Concert Medical Hands-Free Syringe (HFS)
2
Cleared 510(K)
K
15
3193
Halo II Ambulatory Infusion System (also with trade names Nimbus II Ambulatory Infusion System, EVAA Ambulatory Infusion System)
2
Cleared 510(K)
K
15
1255
Navigator Aesthetic Delivery System
2
Cleared 510(K)
K
14
2596
Infusomat Space Volumetric Infusion Pump
2
Cleared 510(K)
K
14
1789
PLUM 360 INFUSION SYSTEM WITH HOSPIRA MEDNET, SMART CARD PLUG N PLAY CE 3.0 MODULE FOR PLUM A+ INFUSION SYSTEM UPGRADE
2
Cleared 510(K)
K
14
1389
SAPPHIRE INFUSION PUMP
2
Cleared 510(K)
K
14
0783
HALO AMBULATORY INFUSION SYSTEM
2
Cleared 510(K)
K
13
3532
ALARIS SYSTEM WITH GUARDRAILS SUITE MX
2
Cleared 510(K)
K
14
1654
THE BELMONT RAPID INFUSER
2
Cleared 510(K)
K
14
1102
HOSPIRA MEDNET MEDICATION MANAGEMENT SUITE
2
Cleared 510(K)
K
13
3801
BAXTER SIGMA SPECTRUM INFUSION PUMP WITH MASTER DRUG LIBRARY
2
Cleared 510(K)
K
12
3049
SAPPHIRE INFUSION PUMP
2
Cleared 510(K)
K
12
3822
KLEIN TOUCH PUMP AND DISPOSABLE TUBING SET
2
Cleared 510(K)
K
13
0690
Z-800 INFUSION SYSTEM
2
Cleared 510(K)
K
12
1613
AGILIA INFUSION SYSTEM
2
Cleared 510(K)
K
12
4053
NAVIGATOR DELIVERY SYSTEM (NAVIGATOR DS)
2
Cleared 510(K)
K
11
1275
CADD SOLIS VIP AMBULATORY INFUSION PUMP AND CADD SOLIS MEDICATION SAFETY SOFTWARE
2
Cleared 510(K)
K
12
2215
NAVIGATOR DELIVERY SYSTEM (NAVIGATOR DS)
2
Cleared 510(K)
K
12
0830
NAVIGATOR DELIVERY SYSTEM (NAVIGATOR DS)
2
Cleared 510(K)
K
11
0535
ALARIS PC UNIT MODULE 8000 WITH SOFTWARE CORRECTION
2
Cleared 510(K)
K
11
0901
SYMBIQ INFUSION AND ADMINSTRATION SET
2
Cleared 510(K)
K
11
2067
NAVIGATOR DELIVERY SYSTEM (NAVIGATOR DS)
2
Cleared 510(K)
K
11
1386
MEDFUSION MODEL 4000 SYRINGE INFUSION PUMP, PHARMGUARD TOOLBOX 2 MEDICATION SAFETY SOFTWARE AND SUPPORTED SYRINGES (PSS)
2
Cleared 510(K)
K
10
1194
NAVIGATOR DELIVERY SYSTEM (OR NAVIGATOR DS) MODEL: NAV-010
2
Cleared 510(K)
K
10
0705
ZYNO Z-800 INFUSION SYSTEM MODEL Z-800
2
Cleared 510(K)
K
10
0798
MEDRAD INTEGO PET INFUSION SYSTEM, SOURCE ADMINISTRATION SET, PATIENT ADMINSTRATIN SET MODEL INT SYS 100, INT CSS, INT C
2
Cleared 510(K)
K
10
0704
ACCU-CHEK FLEXLINK PLUS INFUSION SET, ACCU-CHECK LINKASSIST PLUS INSERTION DEVICE
2
Cleared 510(K)
K
09
3332
DELPHI INFUSION PUMP/ DELPHI ADMINISTRATION SET MODEL IV-01000/ MODEL IV-02XXXX (WHERE X IS ANY NUMBER BETWEEN 0-9)
2
Cleared 510(K)
K
09
1441
SYNERGETICS ADJUSTABLE GAS PRESSURIZED INFUSION (AGPI) TUBE SET
2
Cleared 510(K)
K
09
1386
MICROFUSE DUAL RATE INFUSER
2
Cleared 510(K)
K
09
1308
ALARIS PC UNIT, MODELS 8000 AND 8015
2
Cleared 510(K)
K
09
1855
THE BELMONT FLUID MANAGEMENT SYSTEM/ THE BELMONT RAPID INFUSER, MODEL FMS2000
2
Cleared 510(K)
K
08
3689
INFUSOMAT SPACE VOLUMETRIC INFUSION PUMP SYSTEM
2
Cleared 510(K)
K
09
0736
POWER INFUSER, MODEL M100B-3A
2
Cleared 510(K)
K
09
1042
CRONO S-PID 50
2
Cleared 510(K)
K
09
0087
MRIDIUM 3860 MRI INFUSION PUMP/MONITORING SYSTEM
2
Cleared 510(K)
K
08
1412
PLUM A+ HYPERBARIC INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE
2
Cleared 510(K)
K
07
2603
ABC SYRINGE INFUSION PUMP, MODEL 4100
2
Cleared 510(K)
K
08
3019
GEMSTAR SP INFUSION SYSTEM WITH GEMSTAR SP INFUSION SUITE SOFTWARE
2
Cleared 510(K)
K
08
2182
AP 34 MULTI-THERAPY INFUSION PUMP
2
Cleared 510(K)
K
08
0297
MEDRAD INTEGO PET INFUSION SYSTEM
2
Cleared 510(K)
K
07
3051
MEDRAD CONTINUUM MR INFUSION SYSTEM WITH WIRELESS REMOTE ACCESSORY
2
Cleared 510(K)
K
08
0954
T34L SYRINGE DRIVER
2
Cleared 510(K)
K
08
0743
LOCKBOX FOR USE WITH CADD SOLIS INFUSION PUMP
2
Cleared 510(K)
K
07
2105
ALARIS SYSTEM WITH MMS, MODEL 8XXX
2
Cleared 510(K)
K
07
1588
DISPENSER DP 20
2
Cleared 510(K)
K
07
1545
Z-800 VOLUMETRIC INFUSION PUMP
2
Cleared 510(K)
K
07
0235
BODYGUARD PAIN MANAGER INFUSION SYSTEM
2
Cleared 510(K)
K
07
0529
AFF (MARK I) VOLUMETRIC INFUSION PUMP
2
Cleared 510(K)
K
07
0398
HOSPIRA PLUM A+ INFUSION PUMP, MODEL 12391
2
Cleared 510(K)
K
07
0125
COLLEAGUE GUARDIAN CONFIGURATION TOOL; COLLEAGUE DL2 EVENT HISTORY DOWNLOAD SOFTWARE APPLICATION
2
Cleared 510(K)
K
07
0718
MODIFICATION TO: BODYGUARD INFUSION SYSTEM
2
Cleared 510(K)
K
06
3696
COLLEAGUE VOLUMETRIC INFUSION PUMP MODEL# 2M8151,8153,8161,8163,9161,9163
2
Cleared 510(K)
K
07
0268
SIGNATURE EDITION INFUSION SYSTEM, MODELS 710X, 720X
2
Cleared 510(K)
K
06
1108
STRYKER AUTO IRRIGATION SYSTEM
2
Cleared 510(K)
K
05
2973
IPUMP PAIN MANAGEMENT SYSTEM, MODEL 2L3107, 2L3107K
2
Cleared 510(K)
K
06
2592
CADD-SENTRY PRO MEDICATION SAFETY SOFTWARE
2
Cleared 510(K)
K
06
3288
SIGNATURE EDITION GOLD INFUSION SYSTEM, MODEL 7X3X
2
Cleared 510(K)
K
06
2700
INFUSOMAT SPACE VOLUMETRIC INFUSION PUMP SYSTEM
2
Cleared 510(K)
K
06
2699
PERFUSOR SPACE INFUSION SYRINGE PUMP SYSTEM
2
Cleared 510(K)
K
06
1325
BODYGAURD PAIN MANAGER INFUSION SYSTEM
2
Cleared 510(K)
K
05
3554
COMPUFLO
2
Cleared 510(K)
K
06
1128
MODIFICATION TO MEDRAD CONTINUUM MR INFUSION SYSTEM
2
Cleared 510(K)
K
06
0479
MODIFICATION TO BODYGUARD INFUSION PUMP SYSTEM
2
Cleared 510(K)
K
06
0806
HOSPIRA GEMSTAR INFUSION PUMP SYSTEM, 7 THERAPY, MODEL 13087; 6 THERAPY, MODEL 13086; PAIN MANAGEMENT, MODEL 13088
2
Cleared 510(K)
K
05
2817
EUREKA INFUSION PUMP, MODELS EUREKA-IP, EUREKA-LF
2
Cleared 510(K)
K
06
0119
MCKINLEY SATURATION CATHETER
2
Cleared 510(K)
K
05
2594
WILLCARE, MODEL GW-1020
2
Cleared 510(K)
K
05
3226
ZIMMER AMBULATORY PUMP PAIN MANAGEMENT SYSTEMS WITH FENESTRATED CATHETER AND FLOW SPLITTER
2
Cleared 510(K)
K
05
2221
AMBIT PUSH & PLAY AMBULATORY INFUSION PUMP
2
Cleared 510(K)
K
05
2218
CRONO FIVE AND CRONO PCA 50
2
Cleared 510(K)
K
05
0800
NIKI T34 AND BODYGUARD T34 SYRINGE DRIVERS
2
Cleared 510(K)
K
05
1568
CADD-MS 3 AMBULATORY INFUSION PUMP
2
Cleared 510(K)
K
05
1641
ALARIS SYSTEM PC UNIT, MODEL 8001
2
Cleared 510(K)
K
05
2171
ZIMMER AMBULATORY PUMP PAIN MANAGEMENT SYSTEM WITH PATIENT CONTROL MODULE
2
Cleared 510(K)
K
05
2217
CRONO SUPER PID
2
Cleared 510(K)
K
05
2219
CRONO GO.
2
Cleared 510(K)
K
05
2052
HOSPIRA PLUM A+ INFUSION PUMP SYSTEM V11.5, HOSPIRA PLUM A+ 3 INFUSION PUMP SYSTEM, V11.5
2
Cleared 510(K)
K
05
1045
SIMPLECHOICE 3.0 ML RESERVOIR PRO REFERENCE NUMBER RP-30
2
Cleared 510(K)
K
05
1252
MICROPUMP MP-101
2
Cleared 510(K)
K
04
3466
PAINPUMP2
2
Cleared 510(K)
K
05
0324
INFPUMP INFILTRATION PUMP
2
Cleared 510(K)
K
05
0474
VEINNOVATIONS INFILTRATION SYSTEM
2
Cleared 510(K)
K
05
0433
ZIMMER AMBULATORY PUMP PAIN MANAGEMENT SYSTEM
2
Cleared 510(K)
K
04
3204
SGARLATO LABS PAINFREE PUMP AND PAIN CONTROL INFUSION PUMP
2
Cleared 510(K)
K
04
3600
MEDTRONIC MICROMED 407C INFUSION PUMP, MODEL MMT-407C
2
Cleared 510(K)
K
04
3590
SE INFUSION SYSTEM WITH MMS
2
Cleared 510(K)
K
05
0301
MRIDIUM 3850 MRI PUMP SYSTEM
2
Cleared 510(K)
K
04
2696
BODYGUARD INFUSION PUMP SYSTEM
2
Cleared 510(K)
K
05
0107
HARVARD 2 SYRINGE PUMP, MODEL 2001-001
2
Cleared 510(K)
K
04
2432
PHARMGUARD TOOLBOX, MODEL G6000782
2
Cleared 510(K)
K
04
0985
PUMP CONNECTIVITY INTERFACE
2
Cleared 510(K)
K
04
2980
HOSPIRA GEMSTAR INFUSION PUMP SYSTEM, HOSPIRA GEMSTAR CONNECT SOFTWARE
2
Cleared 510(K)
K
04
2228
BEELINE MOTIV, PROPOLIS, PCA
2
Cleared 510(K)
K
04
2405
PAINPUMP1; PAINPUMP2
2
Cleared 510(K)
K
04
2609
HOSPIRA MEDNET MEDICATION MANAGEMENT SUITE
2
Cleared 510(K)
K
04
1714
E-PAIN CARE
2
Cleared 510(K)
K
04
2085
CRONO F
2
Cleared 510(K)
K
04
2121
SPECTRUM AND SPECTRUM WITH MASTER DRUG LIBRARY
2
Cleared 510(K)
K
04
2081
PLUM A+ INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE , AND PLUM A+3 INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE
2
Cleared 510(K)
K
04
1738
BAXTER INFUSOR SV (SMALL VOLUME); BAXTER INFUSOR LV (LARGE VOLUME)
2
Cleared 510(K)
K
04
1414
CRONO AND CRONO, MODEL 30
2
Cleared 510(K)
K
04
1241
MEDLEY SYSTEM WITH BAR CODE MODULE, MODEL 8600
2
Cleared 510(K)
K
04
1550
HOSPIRA PHOENIX INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE
2
Cleared 510(K)
K
04
1191
COLLEAGUE VOLUMETRIC INFUSION PUMPS
2
Cleared 510(K)
K
04
0149
PSI-TEC PERISTALTIC INFILTRATION PUMP
2
Cleared 510(K)
K
04
1152
THINSET 1.8 ML RESERVOIR, MODEL 326A; THINSET 3.0 ML RESERVOIR, MODEL 332A
2
Cleared 510(K)
K
04
0899
MEDEX 3000 SERIES MR SYRINGE INFUSION PUMP
2
Cleared 510(K)
K
04
0061
MEDTRONIC MINIMED MMT-407C AMBULATORY INFUSION PUMP, MODEL MMT-407C
2
Cleared 510(K)
K
04
0114
ABBOTT DATA PORT PC, MODEL 12181
2
Cleared 510(K)
K
03
0739
INFUSION DYNAMICS (ID) POWER INFUSER, MODEL M100B-3A WITH BLOOD CARTRIDGE
2
Cleared 510(K)
K
03
3425
AMBIT INTERMITTENT AMBULATORY INFUSION PUMP
2
Cleared 510(K)
K
03
3325
AMBIT CONTINUOUS AMBULATORY INFUSION PUMP
2
Cleared 510(K)
K
03
2789
REPLACEMENT PUMP HEAD DOOR ASSEMBLY, P1, MODEL BX10468, REPLACEMENT PUMP HEAD DOOR ASSEMBLY, P2, MODEL BX10469
2
Cleared 510(K)
K
03
2771
MEDRAD CONTINUUM MR INFUSION SYSTEM
2
Cleared 510(K)
K
03
2642
BEELINE SYSTEM
2
Cleared 510(K)
K
03
2005
MEDTRONIC MINIMED PARADIGM RESERVOIR, MODEL MMT-332
2
Cleared 510(K)
K
03
1749
BODYGUARD INFUSION SYSTEM
2
Cleared 510(K)
K
03
1600
CONDUCTION CATHETER
2
Cleared 510(K)
K
03
1432
KLEIN SURGICAL INFILTRATION PUMP, MODEL KIP-II
2
Cleared 510(K)
K
03
2147
SIGNATURE EDITION INFUSION PUMP, SIGNATURE EDITION ADMINISTRATION SETS, MODELS 70XX, 71XX, 72XX, 7XXXX SERIES
2
Cleared 510(K)
K
03
1249
MODIFICATION TO STRYKER PAINPUMP
2
Cleared 510(K)
K
03
0576
ANSPACH IRRIGATION PUMP AND IRRIGATION PUMP II
2
Cleared 510(K)
K
03
1185
ABBOTT PLUM A+ INFUSION PUMP WITH A HPL/RS PLUG-AND-PLAY MODULE
2
Cleared 510(K)
K
03
0885
MODIFICATION TO STRYKER PAINPUMP2
2
Cleared 510(K)
K
03
0459
MEDLEY SYSTEM WITH MEDICATION MANAGEMENT SYSTEM (MMS)
2
Cleared 510(K)
K
03
0323
MRI-CADDY
2
Cleared 510(K)
K
02
3189
VISTA BASIC WITH FM SYSTEM
2
Cleared 510(K)
K
02
4190
FENESTRATED INFUSION CATHETER
2
Cleared 510(K)
K
02
3083
SILBERG T.P.S., TISSUE PREPARATION SYSTEM, MODEL ME 800
2
Cleared 510(K)
K
02
3973
AUTOMED 3200 INFUSION PUMP
2
Cleared 510(K)
K
02
3863
AUTOMED 3000 INFUSION PUMP
2
Cleared 510(K)
K
02
4056
SURESET 3.0 ML RESERVOIR, MODEL 24-103
2
Cleared 510(K)
K
02
4084
ABBOTT PLUM A+ INFUSION PUMP, MODEL 12391
2
Cleared 510(K)
K
02
3264
MEDLEY SYRINGE PUMP MODULE SYSTEM, MODEL 8110
2
Cleared 510(K)
K
02
3827
PARAGON INFUSION SYSTEM WITH BOLUS
2
Cleared 510(K)
K
02
3491
AUTOMED 3300 AND 3400 INFUSION PUMP SYSTEM
2
Cleared 510(K)
K
02
3062
GEMSTAR INFUSION PUMP SYSTEM, 7 THERAPY, 6 THERAPY & PAIN MANAGEMENT
2
Cleared 510(K)
K
02
2869
SOAKER CATHETER
2
Cleared 510(K)
K
02
1988
MEDRAD CONTINUUM MR COMPATIBLE INFUSION SYSTEM
2
Cleared 510(K)
K
02
2575
PERFUSOR COMPACT WITH FM SYSTEM
2
Cleared 510(K)
K
02
1350
ABBOTT PLUM A+3 MULTICHANNEL INFUSION PUMP, MODEL 12348
2
Cleared 510(K)
K
01
3840
MICROJET CRONO PAR AND CRONO APO-GO
2
Cleared 510(K)
K
01
3855
MICROJET CRONO H
2
Cleared 510(K)
K
01
3776
MICROJET MODEL # CD4 AND CD4/20
2
Cleared 510(K)
K
01
3234
MICROJET CRONO
2
Cleared 510(K)
K
02
0947
MODIFICATION TO DYONICS INTELIJET REUSABLE CANNULAS
2
Cleared 510(K)
K
02
0881
MODIFICATION TO PERSONAL INFUSOR LOCAL PAIN MANAGEMENT PROCEDURAL KIT
2
Cleared 510(K)
K
02
0251
PARAGON INFUSION SYSTEM
2
Cleared 510(K)
K
01
4091
STRYKER PAINPUMP
2
Cleared 510(K)
K
01
3767
SIMPLICITY INFUSION RESERVOIR FOR USE TO INFUSE MEDICINE, INCLUDING INSULIN, FROM AN EXTERNAL INFUSION PUMP
2
Cleared 510(K)
K
01
2383
GEMINI PC-1,PC-2, PC-2TX,PC-4, SIGNATURE EDITION INFUSION PUMP (SE), MEDSYSTEM III INFUSION (MSIII), MEDSYSTEM PATIENT C
2
Cleared 510(K)
K
01
1975
HORIZON OUTLOOK WITH DOSECOM
2
Cleared 510(K)
K
01
2044
BI-PHASIC INFILTRATOR
2
Cleared 510(K)
K
00
3966
WUNDCATH CONDUCTION CATHETER
2
Cleared 510(K)
K
01
0937
SEP-10S PLUS, AND SP-12S PRO.
2
Cleared 510(K)
K
01
1442
ABBOTT PLUM A+INFUSION PUMP, MODEL 11971
2
Cleared 510(K)
K
00
3543
STRYKER PAINPUMP PCA
2
Cleared 510(K)
K
01
0566
COLLEAGUE VOLUMETRIC INFUSION PUMP
2
Cleared 510(K)
K
01
1096
ABBOTT ACCLAIM ENCORE, MODEL 12237
2
Cleared 510(K)
K
01
0924
MODIFICATION TO PLUM XL INFUSION PUMP
2
Cleared 510(K)
K
00
3611
PAIN CARE MULTI-PORT CATHETER, MODEL 2000L
2
Cleared 510(K)
K
00
3616
COLLEAGUE (3CX, 3, CX) VOLUMETRIC INFUSION PUMP
2
Cleared 510(K)
K
00
3582
FLUIDSENSE FLUID DELIVERY SYSTEM MODEL FS-01
2
Cleared 510(K)
K
00
3029
INFUSOMAT P
2
Cleared 510(K)
K
00
2679
6060 MULTI-THERAPY PUMP, MODEL 2M9832; 6060 EPIDURAL PUMP, MODEL 2L9351
2
Cleared 510(K)
K
00
2380
INFUSOR SV, INFUSOR LV, BAXTER PAIN MANAGEMENT SYSTEM
2
Cleared 510(K)
K
00
1829
MINIMED PARADIGM INSULIN PUMP, MODEL 511
2
Cleared 510(K)
K
00
1828
PARADIGM 1.5ML RESERVOIR, MODEL 326
2
Cleared 510(K)
K
99
3524
ADVANTIS ASC INFUSION PUMP AND ADMINISTRATION SETS
2
Cleared 510(K)
K
00
2211
COLLEAGUE CX VOLUMETRIC INFUSION PUMP 2M8161 AND VOLUMETERIC INFUSION PUMP 2M8151
2
Cleared 510(K)
K
00
2126
ABBOTT ACCLAIM ENCORE STANDARD TUBING PUMP
2
Cleared 510(K)
K
00
1629
DISETRONIC MULTIFUSE INFUSION PUMP SYSTEM
2
Cleared 510(K)
K
00
0842
CADD-PRIZM PCS II MODEL 6101 AMBULATORY INFUSION SYSTEM
2
Cleared 510(K)
K
99
4274
QUEST MPS PERFUSION ASSISTED DIRECT CORONARY ARTERY BYPASS (PADCAB)
2
Cleared 510(K)
K
00
0328
MEDEX 3000 SERIES MRI COMPATIBLE SYRINGE INFUSION PUMP
2
Cleared 510(K)
K
00
0821
ABBOTT GEMSTAR I.V. INFUSION PUMP - 7 THERAPY CONFIGURATION, 6 THERAPY CONFIGURATION, 1 THERAPY CONFIGURATION
2
Cleared 510(K)
K
99
4375
HORIZON LIGHT
2
Cleared 510(K)
K
99
4374
SOAKER CATHETER
2
Cleared 510(K)
K
99
4275
SIMS PORTEX ANESTHESIA CATHETER
2
Cleared 510(K)
K
99
1936
3.0 ML RESERVOIR, MODEL 103/193
2
Cleared 510(K)
K
99
4039
ABBOTT GEMSTAR I.V. INFUSION PUMP-7 THERAPY CONFIGURATION, ABBOTT GEMSTAR I.V. INFUSION PUMP-6 THERAPY CONFIGURATION, AB
2
Cleared 510(K)
K
99
3387
IPUMP PAIN MANAGEMENT SYSTEM, MODEL 2L3107K
2
Cleared 510(K)
K
99
1203
IRRIGATION OR INFUSION PUMP K PUMP
2
Cleared 510(K)
K
99
2044
INFUSION DYNAMICS POWER INFUSER MODEL M100B
2
Cleared 510(K)
K
99
1437
WELLS JOHNSON INFUSION SYSTEM, MODEL 20-6000-00
2
Cleared 510(K)
K
99
2672
BELMONT FLUID MANAGEMENT SYSTEM (FMS2000)
2
Cleared 510(K)
K
99
1275
WALKMED 300, WALKMED 350, WALKMED IC, WALKMED PCA, WALKMED PLUS
2
Cleared 510(K)
K
99
1013
MINIMED 407C INFUSION PUMP, MODEL 407C
2
Cleared 510(K)
K
99
1501
ACCLAIM INFUSION PUMP
2
Cleared 510(K)
K
99
1363
30 PUMP, CONTINUOUS LOW FLOW, 200 PUMP, INTERMITTENT WITH KVO OR CONTINUOUS, PCA PUMP, PAIN MANAGEMENT, PCEA PUMP, EPIDU
2
Cleared 510(K)
K
99
0447
1000 PRESSURE INFUSION SIGMACON 1000
2
Cleared 510(K)
K
99
0425
SIDEKICK INFUSION KIT
2
Cleared 510(K)
K
98
2640
MEDEX 3000 SERIES SYRINGE INFUSION PUMP
2
Cleared 510(K)
K
99
0518
PEREGRINE WET SET, MODEL PD400.00
2
Cleared 510(K)
K
99
0101
PAIN CONTROL INFUSION PUMP
2
Cleared 510(K)
K
98
0751
SABRATEK 4040 INFUSION PUMP
2
Cleared 510(K)
K
99
0259
DISETRONIC MULTIFUSE INFUSION PUMP SYSTEM
2
Cleared 510(K)
K
98
3005
PERFUSOR COMPACT
2
Cleared 510(K)
K
98
2159
ABBOTT PLUM A+ INFUSION PUMP
2
Cleared 510(K)
K
97
4332
VARIABLE PRESSURE SYRINGE PUMP
2
Cleared 510(K)
K
98
0378
MELODIE INFUSION PUMP
2
Cleared 510(K)
K
98
1816
CUE AMBULATORY VOLUMETRIC INFUSION PUMP
2
Cleared 510(K)
K
98
3975
BELMONT FLUID MANAGEMENT SYSTEM (FMS2000)
2
Cleared 510(K)
K
98
2170
FLUIDSENSE FLUID DELIVERY SYSTEM
2
Cleared 510(K)
K
98
3838
ABBOTT LIFECARE STANDARD TUBING INFUSION PUMP
2
Cleared 510(K)
K
98
2838
CADD-LEGACY 1 AMBULATORY INFUSION SYSTEM MODEL NUMBER 6400
2
Cleared 510(K)
K
98
2836
CADD-LEGACY PLUS AMBULATORY INFUSION SYSTEM
2
Cleared 510(K)
K
98
3321
MICROFUSE DUAL RATE INFUSER
2
Cleared 510(K)
K
98
2020
METRON QA-IDS I.V. PUMP TESTER
2
Cleared 510(K)
K
97
3593
BRIDGE SENTRY BEDSIDE UNIT, BRIDGE SENTRY ADMINISTRATION SET-STANDARD CONFIGURATION, BRIDGE SENTRY ADMINISTRATION SET 5
2
Cleared 510(K)
K
98
1776
ALEXANDER MANUFACTURING CO. BATTERY PART NUMBER MC146X
2
Cleared 510(K)
K
98
0738
PSI-TEC SYRINGE INFUSION PUMP AND ACCESSORIES FOR GENERAL FLUID IRRIGAION/INFILTRATION
2
Cleared 510(K)
K
98
0089
3600 PRESURE INFUSOR, SIGMACON 3600, LAPRO FLOW 3000
2
Cleared 510(K)
K
97
4778
ABBOTT GEMSTAR IV INFUSION PUMP
2
Cleared 510(K)
K
98
0092
SMITH & NEPHEW DYONICS INTELIJET REUSABLE CANNULAS
2
Cleared 510(K)
K
97
3917
CADD-DIPLOMAT PC COMMUNICATIONS SYSTEM AND THE CADD- AMBASSADOR PUMP COMMUNICATIONS SYSTEM
2
Cleared 510(K)
K
97
3851
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY #M12/630
2
Cleared 510(K)
K
97
3609
IDA-4 AND IPT-MC
2
Cleared 510(K)
K
97
2284
FLUID MANAGEMENT SYSTEM
2
Cleared 510(K)
K
97
2678
MILLENNIUM CRT INFUSION PUMP AND MILLENNIUM CRT INFUSION PUMP ADMINISTRATION SETS
2
Cleared 510(K)
K
97
3133
BIG BAG 3000 PRESSURE INFUSOR
2
Cleared 510(K)
K
96
3574
PULSE*SPRAY INJECTOR
2
Cleared 510(K)
K
96
5230
ABBOTT LIFECARE STANDARD TUBING INFUSION PUMP
2
Cleared 510(K)
K
96
1862
MODELS IDA-2 PLUS AND IPT-1
2
Cleared 510(K)
K
96
1975
DISETRONIC D-MODEM
2
Cleared 510(K)
K
96
0512
GEMINI PC-ITX
2
Cleared 510(K)
K
96
2709
SIGMA SYRINGE DELIVERY SYSTEM(MULTI-DOSER REV. 1/MULTI-DOSER REV. II/SINGLE-DOSER REV. 1-10/SINGLE-DOSER REV. 1-20/
2
Cleared 510(K)
K
96
1263
MODEL 1200 ABMULATORY INFUSION PUMP
2
Cleared 510(K)
K
96
0826
CADD-PRIZM MODEL 6100 PUMP
2
Cleared 510(K)
K
95
5231
MEDFUSION MODEL 2001 SYRINGE INFUSION PUMP
2
Cleared 510(K)
K
96
1703
COLLEAGUE 2 VOLUMETRIC INFUSION PUMP(DUAL CHANNEL)/COLLEAGUE 3 VOLUMETRIC INFUSION PUMP(TREE CHANNEL)
2
Cleared 510(K)
K
96
0957
EXTERNAL POWER SOURCE (EPS) SYSTEM, POWER PACK
2
Cleared 510(K)
K
95
5258
3030 INFUSION PUMP
2
Cleared 510(K)
K
95
4826
DISETRONIC MULTIFUSE PUMP SYSTEM
2
Cleared 510(K)
K
95
5180
CADD-PCA, -MICRO, -PRIZM AMBULATORY INFUSION PUMP
2
Cleared 510(K)
K
95
3896
THE IMED AMBULATORY INFUSION PUMP, ADMINISTRATION SETS
2
Cleared 510(K)
K
95
2967
UNIMED MEDICAL DISPENSING PUMP
2
Cleared 510(K)
K
95
2799
ABBOTT XL3M INFUSION PUMP
2
Cleared 510(K)
K
95
3098
VOLUMETRIC INFUSION PUMP
2
Cleared 510(K)
K
95
3731
PANCRETEC PROVIDER APM INFUSION PUMP (MODIFICATION)
2
Cleared 510(K)
K
94
4352
SMARTDOSE III INFUSION CONTAINER
2
Cleared 510(K)
K
94
4351
SMARTDOSE IV PREFILLED INFUSION CONTAINER
2
Cleared 510(K)
K
95
3660
PLUM XL INFUSION PUMP (MODIFICATION)
2
Cleared 510(K)
K
95
3382
ACCUPUMP 901 (MODEL NUMBERS 50 & 100)
2
Cleared 510(K)
K
95
3270
MODEL 1100 MEDMATE INFUSION PUMP
2
Cleared 510(K)
K
94
3952
DISETRONIC D-MODEM
2
Cleared 510(K)
K
93
3825
ADI SYSTEM
2
Cleared 510(K)
K
95
2794
HARVARD 2 SYRINGE PUMP
2
Cleared 510(K)
K
94
4721
9000 INFUSION PUMP
2
Cleared 510(K)
K
94
4669
FLEXIFLO QUANTUM ENTERAL PUMP
2
Cleared 510(K)
K
94
5942
AUTO SYRINGE(R) AS50 INFUSION PUMP
2
Cleared 510(K)
K
95
0419
THE IMED ORION INFUSION PUMP AND ADMINISTRATION SETS
2
Cleared 510(K)
K
94
4750
CORFLO 300 PUMP
2
Cleared 510(K)
K
94
4190
LIFECARE 175 INFUSER, MODIFICATION
2
Cleared 510(K)
K
94
3692
SMART DOSE(TM)
2
Cleared 510(K)
K
95
0766
SIGMA 8000 AND SIGMA 8002
2
Cleared 510(K)
K
94
2378
POCKET PUMP
2
Cleared 510(K)
K
94
4733
PLUM XL INFUSION PUMP
2
Cleared 510(K)
K
94
1595
MICROJECT MODEL 200, MODEL 30, AND MODEL TPN-5
2
Cleared 510(K)
K
93
1318
3400 INFUSION PUMP
2
Cleared 510(K)
K
94
4125
ABBOTT LTE INFUSION PUMP
2
Cleared 510(K)
K
94
2162
SIGMA 8000 AND SIGMA 8002
2
Cleared 510(K)
K
93
3545
SIEMENS FLUID DELIVERY SYSTEM, MMT-9500
2
Cleared 510(K)
K
94
0446
3M MODEL 3000 & MODEL 3100 INFUSION PUMP (MODIFICATION)
2
Cleared 510(K)
K
94
2161
LOCKBOX
2
Cleared 510(K)
K
94
1984
SABRATEK 6060 HOMERUN VOLUMETRIC INFUSION PUMP
2
Cleared 510(K)
K
92
2702
PROVIDER ANNE INFUSER
2
Cleared 510(K)
K
94
1151
STRATOFUSE PCA II INFUSER
2
Cleared 510(K)
K
93
2847
CORPAK ENTERAL PUMP
2
Cleared 510(K)
K
93
3652
FREEDOM 60 SYRINGE INFUSION PUMP SYSTEM WITH SYRINGE SET & TUBING
2
Cleared 510(K)
K
93
0494
PANOJECT MINIFUSOR MODEL 100 AMBULATORY INFUSION
2
Cleared 510(K)
K
93
0495
PANOJECT MINIFUSOR MODEL 200 AMBU. INFUSION PUMP
2
Cleared 510(K)
K
92
6385
BARD APII PUMP
2
Cleared 510(K)
K
94
0147
AUTO SYRINGE AS40A INFUSION PUMP
2
Cleared 510(K)
K
93
2895
RIVER PUMP
2
Cleared 510(K)
K
93
1458
MEDIPAK AMBULATORY INFUSION PUMP
2
Cleared 510(K)
K
92
4603
PHARMETRIX MINIPUMP MODEL 5120
2
Cleared 510(K)
K
92
4527
VIVUS 5000 INFUSION SYSTEM
2
Cleared 510(K)
K
93
4671
HI-FLO INFUSION PUMP
2
Cleared 510(K)
K
91
5649
BARD 500ML RESERVOIR HOLDER
2
Cleared 510(K)
K
93
3506
SYRINGE INFUSER
2
Cleared 510(K)
K
92
3224
KVOI.V. FLUSH SYSTEM
2
Cleared 510(K)
K
91
0007
SPRINGFUSOR 10R
2
Cleared 510(K)
K
92
3290
COMPUTER - COMPUTERS AND SOFTWARE, MEDICAL USE
2
Cleared 510(K)
K
93
3005
AVI MODEL 600 SYRINGE PUMP
2
Cleared 510(K)
K
93
3006
AVI INFUSION PUMPS, ADDITIONAL INTENDED USE
2
Cleared 510(K)
K
93
3144
GEMINI VOLUMETRIC INFUSION PUMP/CONTROLLER
2
Cleared 510(K)
K
93
2544
IVAC SPACE SAVER VOLUMETRIC PUMP, MODEL 599
2
Cleared 510(K)
K
93
1549
MODEL EZ-1 SING CHAN/EZ-2 DUAL CHANNEL INFUS PUMP
2
Cleared 510(K)
K
92
2670
THE MINIMED MODEL 404-SP AND 504-S
2
Cleared 510(K)
K
92
1901
PORT ACCESS INFUSION SET
2
Cleared 510(K)
K
93
1375
ABBOTT PLUM XL INFUSION PUMP
2
Cleared 510(K)
K
92
6191
SIGMA 7000 AND SIGMA70002
2
Cleared 510(K)
K
93
1132
CADD-MICRO(TM) MODEL 5900 AMBULATORY INFUSION PUMP
2
Cleared 510(K)
K
93
0781
INFUSION PUMP
2
Cleared 510(K)
K
92
5311
TRILOGY INFUSION PUMP
2
Cleared 510(K)
K
93
0459
BARD MINI-INFUSER 1500 & 3000
2
Cleared 510(K)
K
92
1050
ULTRAFLO RATESAVER PLUS INFUSION PUMP
2
Cleared 510(K)
K
92
5091
IVAC SYRING PUMP MODEL 770
2
Cleared 510(K)
K
92
5196
BARD EPIDURAL PUMP
2
Cleared 510(K)
K
92
5112
BIO CLINIC UNDER PATIENT SCALE
2
Cleared 510(K)
K
92
4871
MODEL 880 INFUSION PUMP, MODIFICATION
2
Cleared 510(K)
K
92
4865
MODEL 285 INFUSION PUMP, MODIFICATION
2
Cleared 510(K)
K
92
4872
MODEL 885 INFUSION PUMP, MODIFICATION
2
Cleared 510(K)
K
92
4870
MODEL 480CI INFUSION PUMP, MODIFICATION
2
Cleared 510(K)
K
92
4869
MODEL 480CM INFUSION PUMP, MODIFICATION
2
Cleared 510(K)
K
92
4868
MODEL 480 INFUSION PUMP, MODIFICATION
2
Cleared 510(K)
K
92
4867
285CI INFUSION PUMP, MODIFICATION
2
Cleared 510(K)
K
92
4866
MODEL 285CM INFUSION PUMP, MODIFICATION
2
Cleared 510(K)
K
92
3875
SIDEKICK 50 PLUS AND SIDEKICK 100 PLUS
2
Cleared 510(K)
K
92
5449
REPLACEMENT RECHARGEABLE BATTERY PACK'S
2
Cleared 510(K)
K
92
3068
AVI MODEL 3100 INFUSION PUMP
2
Cleared 510(K)
K
92
3829
LIFECARE 175 INFUSER -- MODIFICATION
2
Cleared 510(K)
K
92
2074
DCR VOLUMETRIC INFUSION PUMP W/ NEW MAINS POWER PK
2
Cleared 510(K)
K
92
3981
IVAC SYRINGE PUMP - 740 SERIES
2
Cleared 510(K)
K
92
3601
PANCRETEC PROVIDER INFUSION PUMP -- MODIFICAITON
2
Cleared 510(K)
K
92
2909
MEDICAL BATTERY PACKS
2
Cleared 510(K)
K
91
4122
VITAL INFUSION PUMP
2
Cleared 510(K)
K
91
5407
PHARMETRIX MEDIPUMP MODEL 524
2
Cleared 510(K)
K
91
5566
DISETRONIC PANOMAT PUMP
2
Cleared 510(K)
K
91
5646
VIVUS 50 AND VIVUS 100 PERSONAL INFUSER
2
Cleared 510(K)
K
92
1378
IMED MODEL PC-4 VOLUMETRIC INFUSION PUMP/CONTROLLE
2
Cleared 510(K)
K
92
1073
AVI MODEL 480CI INFUSION PUMP
2
Cleared 510(K)
K
92
1072
AVI MODEL 470CI INFUSION PUMP
2
Cleared 510(K)
K
91
4589
SABRATEK 3030 INFUSION PUMP
2
Cleared 510(K)
K
92
0013
UNI-DOSE SYRINGE PUMP
2
Cleared 510(K)
K
92
0773
DURAFUSE INFUSION PUMP
2
Cleared 510(K)
K
92
0680
AVI MODEL 275CI INFUSION PUMP
2
Cleared 510(K)
K
92
0681
AVI MODEL 285CI INFUSION PUMP
2
Cleared 510(K)
K
92
0588
AVI MODEL 3000 INFUSION PUMP
2
Cleared 510(K)
K
91
4988
500 INFUSER
2
Cleared 510(K)
K
91
3891
DISETRONIC(R) INFUSOR
2
Cleared 510(K)
K
91
5499
FLO-GARD 8000 HALF-SET
2
Cleared 510(K)
K
91
3931
PANCRETEC PROVIDER(R) MODEL 5500 INFUS PUMP, MODIF
2
Cleared 510(K)
K
91
5523
FLO-GARD(R) 6301
2
Cleared 510(K)
K
91
5522
FLO-GARD(R) 6201
2
Cleared 510(K)
K
91
2193
3000 INFUSION PUMP
2
Cleared 510(K)
K
91
2192
3100 INFUSION PUMP
2
Cleared 510(K)
K
91
4855
MULTIPLE DOSE CONTROLLER
2
Cleared 510(K)
K
91
4854
THUMPER
2
Cleared 510(K)
K
91
5231
EPIDURAL INDICATION FOR VOLUMETRIC INFUSION PUMPS
2
Cleared 510(K)
K
91
4349
PROVIDER APM INFUSION PUMP
2
Cleared 510(K)
K
91
3661
MODIFIED VOLUMETRIC INFUSION PUMP
2
Cleared 510(K)
K
91
3907
VIVUS PS (PROGRAMMING SOFTWARE)
2
Cleared 510(K)
K
91
1782
PUMPMAN(TM) AMBULATORY DRUG DELIVERY SYSTEM
2
Cleared 510(K)
K
91
1103
DANBY D.S.P. SYRINGE PUMP
2
Cleared 510(K)
K
90
4619
INFU.DISK
2
Cleared 510(K)
K
91
4034
INFUCARE SYRINGE PUMP TUBING SET
2
Cleared 510(K)
K
91
3718
PANCRETEC I.V. MODEL 5000 INFUS DEVICE, MODIFIED
2
Cleared 510(K)
K
91
3719
PANCRETEC I.V. MODEL 5500 INFUSER
2
Cleared 510(K)
K
91
3720
PANCRETEC PROVIDER ONE INFUSION SYSTEM, MODIFIED
2
Cleared 510(K)
K
91
3895
FLO-GARD(R) 6200, 6300 & 8000
2
Cleared 510(K)
K
91
2589
AVI MODEL 840D DUAL CHANNEL INFUSION PUMP
2
Cleared 510(K)
K
91
2590
AVI MODEL 400D INFUSION PUMP
2
Cleared 510(K)
K
90
4924
INFUSA PU SYRINGE INFUSION PUMP
2
Cleared 510(K)
K
91
3056
VOLUMETRIC INFUSION PUMP, MODIFICATION
2
Cleared 510(K)
K
91
2591
AVI MICRO 210D INFUSION PUMP
2
Cleared 510(K)
K
90
4923
INFUSA T SYRINGE INFUSION PUMP
2
Cleared 510(K)
K
90
4922
INFUSA D.SLT SYRINGE INFUSION PUMP
2
Cleared 510(K)
K
90
4925
INFUSA TS SYRINGE INFUSION PUMP
2
Cleared 510(K)
K
91
2928
LIFECARE 4100 PCA INFUSER PLUS II
2
Cleared 510(K)
K
91
2914
DANBY-DCR VOLUMETRIC INFUSION PUMP
2
Cleared 510(K)
K
91
2875
AVI MODEL 270CI INFUSION PUMP
2
Cleared 510(K)
K
91
2738
AVI VOLUMETRIC INFUSION PUMPS-VARIOUS MODELS
2
Cleared 510(K)
K
91
2092
MODIFIED LIFECARE MODEL 175 INFUSER
2
Cleared 510(K)
K
91
1964
MODIFIED PANCRETEC PROVIDER ONE INFUSION SYSTEM
2
Cleared 510(K)
K
90
5713
BARD AMBULATORY PUMP TUBING SET
2
Cleared 510(K)
K
90
5778
EPIDURAL INDICATION FOR BAXTER INFUSORS ATTACHMENT
2
Cleared 510(K)
K
91
2458
MODEL 404-SP AND 504-SP INFUSION PUMPS MODIFIED
2
Cleared 510(K)
K
91
0934
FLO-GARD 6300 DUAL CHANNEL VOLUMETRIC INFUSION PUM
2
Cleared 510(K)
K
90
4890
BARD ALFENTANIL INFUSER
2
Cleared 510(K)
K
91
2031
AVI MODEL 870 DUAL CHANNEL INFUSION PUMP
2
Cleared 510(K)
K
91
1769
RATEMINDER(TM) V INFUSION PUMP, MODIFICATION
2
Cleared 510(K)
K
91
0844
INFUSION PUMP
2
Cleared 510(K)
K
91
0024
VOLUMETRIC INFUSION PUMP
2
Cleared 510(K)
K
91
0350
MICREL LTD-PORTABLE INFUSION PUMP-MP20Q
2
Cleared 510(K)
K
91
0758
MICREL LTD - PORTABLE INFUSION MICROPUMP-MP11
2
Cleared 510(K)
K
91
1401
ABBOTT LIFECARE 5000 PUMP
2
Cleared 510(K)
K
91
0919
ABBOTT LIFECARE 5000 PUMP MODIFIED
2
Cleared 510(K)
K
91
1289
EPIDURAL INDICATION FOR BAXTER SYRINGE INFUS PUMP
2
Cleared 510(K)
K
91
0637
MENTOR(R) SUR-E-TROL(R)
2
Cleared 510(K)
K
90
2613
BARD PCA II PUMP WITH PROGRAM CARTRIDGES
2
Cleared 510(K)
K
91
0428
EPIDURAL INDICATION FOR VOLUMETRIC INFUSION PUMPS
2
Cleared 510(K)
K
91
0425
LARGE VOLUME ELASTOMERIC INFUSION DEVICE ATTACH.
2
Cleared 510(K)
K
91
0523
MODIFIED VOLUMETRIC INFUSION PUMPS ATTACHMENTS
2
Cleared 510(K)
K
91
0335
MTP TRANSPORT INFUSION PUMP, MODEL NO. MTPLEA
2
Cleared 510(K)
K
90
5696
STRATOFUSE PCA INFUSER
2
Cleared 510(K)
K
90
5610
MICRORATE INTELLIGENT PUMP
2
Cleared 510(K)
K
90
5611
MICRORATE PLUS INTELLIGENT PUMP
2
Cleared 510(K)
K
90
5251
MTP TRANSPORT INFUSION PUMP MODEL NO. 1001A
2
Cleared 510(K)
K
90
3571
MICREL LTD PORTABLE INFUSION MICROPUMP
2
Cleared 510(K)
K
90
4979
AVI MODEL 600 SYRINGE PUMP, MODIFICATION
2
Cleared 510(K)
K
90
5783
MODIFIED WALKMED 400
2
Cleared 510(K)
K
90
4403
BARD AMBULATORY PCA DRUG DELIVERY SYSTEM
2
Cleared 510(K)
K
90
5029
MODEL 2001, MODIFICATION
2
Cleared 510(K)
K
90
3343
SYRINGE INFUSION PUMP
2
Cleared 510(K)
K
90
2891
VERIFUSE AMBULATORY PUMP
2
Cleared 510(K)
K
90
0217
BARD MICROBORE ANTI-SIPHON NITRO SET
2
Cleared 510(K)
K
90
4518
VOLUMETRIC INFUSION PUMP
2
Cleared 510(K)
K
90
1550
IVAC(R) SYRINGE PUMP - MODEL 770
2
Cleared 510(K)
K
90
3879
IVAC(R) SYRINGE PUMP - MODEL 740
2
Cleared 510(K)
K
90
4048
MULTI DRUG INFUSION SYSTEM
2
Cleared 510(K)
K
90
1978
MULTI-DRUG INFUSION SYSTEM
2
Cleared 510(K)
K
89
7086
PARKER AMBULATORY MEDICATION INFUSION PUMP 2004
2
Cleared 510(K)
K
90
2432
AMBULATORY INFUSER AND ASSOC. FLOW CONTROLLING SET
2
Cleared 510(K)
K
90
2374
CADD-TPN MODEL 5700 AMBULATORY INFUSION SYSTEM
2
Cleared 510(K)
K
90
3782
AVI MODEL 270CM INFUSION PUMP
2
Cleared 510(K)
K
90
3783
AVI MICRO 275CM INFUSION PUMP
2
Cleared 510(K)
K
90
3785
AVI MODEL 400CM INFUSION PUMP
2
Cleared 510(K)
K
90
3786
AVI MICRO 845 DUAL CHANNEL INFUSION PUMP
2
Cleared 510(K)
K
90
3787
AVI MODEL 470CM INFUSION PUMP
2
Cleared 510(K)
K
90
3788
AVI MICRO 285CM INFUSION PUMP
2
Cleared 510(K)
K
90
3781
AVI MODEL 880 DUAL CHANNEL INFUSION PUMP
2
Cleared 510(K)
K
90
3789
AVI MICRO 885 DUAL CHANNEL INFUSION PUMP
2
Cleared 510(K)
K
90
3784
AVI MODEL 480CM INFUSION PUMP
2
Cleared 510(K)
K
90
1755
MODEL 3001 SYRINGE INFUSION PUMP
2
Cleared 510(K)
K
90
0467
LIFECARE MODEL 4 PUMP
2
Cleared 510(K)
K
90
0468
LIFECARE(R) MODEL 3 PUMP
2
Cleared 510(K)
K
90
1065
INFUSION PUMP
2
Cleared 510(K)
K
89
6075
CADD-PCA AMBULATORY INFUSION PUMPS
2
Cleared 510(K)
K
90
2309
PARKER MICROPUMP MODEL 2100
2
Cleared 510(K)
K
90
2835
FTS-100 FLUID TRANSFER SYSTEM
2
Cleared 510(K)
K
89
5644
CADD-PCA AMBULATORY INFUSION PUMPS
2
Cleared 510(K)
K
89
4506
ENTERA-FLO ENTERAL FEEDING PUMP
2
Cleared 510(K)
K
90
0375
BECTON DICKINSON PROGRAM 2 INFUSION PUMP
2
Cleared 510(K)
K
89
6717
PARTNER INFUSION SYSTEM:
2
Cleared 510(K)
K
90
2092
RATEMINDER V INFUSION PUMP W/SECONDARY CAPABILITY
2
Cleared 510(K)
K
90
2409
BECTON DICKINSON 360 INFUSER (TM) SYSTEM
2
Cleared 510(K)
K
89
5710
ABBOTT LIFECARE 4100 PCA INFUSER
2
Cleared 510(K)
K
89
5709
ABBOTT PATIENT CONTROLLED ANALGESIA (PCA) PUMP
2
Cleared 510(K)
K
90
0742
RATE INFUSER PLUS
2
Cleared 510(K)
K
89
0736
TFV-2300 INFUSION PUMP
2
Cleared 510(K)
K
89
5867
PANCRETEC I.V. MODEL 5000 INFUSER
2
Cleared 510(K)
K
89
3769
LIFECARE MICRO PUMP (INFUSION PUMP)
2
Cleared 510(K)
K
89
5436
MODIFIED MINIMED III INFUSION PUMP
2
Cleared 510(K)
K
90
0888
LOCKBOX
2
Cleared 510(K)
K
89
6422
BURRON AMBULATORY DRUG DELIVERY SYSTEM
2
Cleared 510(K)
K
89
6544
MD2 PERSONAL INFUSION SYSTEM
2
Cleared 510(K)
K
90
0699
FLO-GARD 6300 BLOOD PUMPING INDICATION
2
Cleared 510(K)
K
90
0204
AVI MODEL 840 DUAL CHANNEL INFUSION PUMP
2
Cleared 510(K)
K
90
0057
LIFECARE(R) 175 INFUSER
2
Cleared 510(K)
K
89
7096
MODEL 404A I.V. INFUSION PUMP ANALYZER
2
Cleared 510(K)
K
89
7013
AVI MICRO 210CM INFUSION PUMP
2
Cleared 510(K)
K
89
6546
HOMEPUMP (DISP. ELASTOMERIC INFUSION DEVICE)
2
Cleared 510(K)
K
89
1289
FLO-GARD 6300 DUAL CHANNEL VOLUME INFUSION PUMP
2
Cleared 510(K)
K
89
6023
OHMEDA 9000 SYRINGE PUMP
2
Cleared 510(K)
K
89
5797
IMED 4100 AND 4200 DISPOSABLE INFUSION DEVICE
2
Cleared 510(K)
K
89
6593
BECTON DICKINSON RATE INFUSER II SYSTEM
2
Cleared 510(K)
K
89
5426
AMBULATORY INFUSION PUMP
2
Cleared 510(K)
K
89
4028
AMBULATORY INFUSION SYSTEM AND ACCESSORIES
2
Cleared 510(K)
K
89
1237
MODEL 600 SYRINGE PUMP
2
Cleared 510(K)
K
89
4292
BARD LIBERATOR DISPOSABLE INFUSION SYSTEM
2
Cleared 510(K)
K
89
3488
PULSATILE PUMP FOR GONADORELIN ACETATE
2
Cleared 510(K)
K
89
4321
MODEL 285 INFUSION PUMP
2
Cleared 510(K)
K
89
4320
MODEL 480 INFUSION PUMP
2
Cleared 510(K)
K
89
4360
MODEL 280 INFUSION PUMP
2
Cleared 510(K)
K
89
4041
PUMP-JECT SYRINGE WITH LUER-LOCK
2
Cleared 510(K)
K
89
4037
IVAC(R) SPACE.SAVER(TM) VOLUMETRIC PUMP MODEL 599
2
Cleared 510(K)
K
89
2210
MULTI-DRUG(TM) INFUSION SYSTEM
2
Cleared 510(K)
K
88
3645
LIFECARE MICRO PUMP
2
Cleared 510(K)
K
89
0862
AMBULATORY INFUSION PUMP
2
Cleared 510(K)
K
89
0786
IVSK09 CALIBRATION KIT AN ACCESSORY TO IV7000/7200
2
Cleared 510(K)
K
89
0120
SYRINGE INFUSION PUMP
2
Cleared 510(K)
K
89
2906
60 MICROBORE EXTENSION SET W/ANTI-SIPHON VALVE
2
Cleared 510(K)
K
88
4505
BASAL/BOLUS INFUSORS
2
Cleared 510(K)
K
89
1583
IVAC VARIABLE PRESSURE VOLUMETRIC PUMP, 570 SERIES
2
Cleared 510(K)
K
89
0783
GRIESHABER VISCOELASTIC INJECTION SYSTEM
2
Cleared 510(K)
K
89
0282
RESUBMITTED ABBOTT LIFECARE MODEL 3 HB PUMP
2
Cleared 510(K)
K
88
3609
ACCES. PACKAGE FOR USE W/CARDIOGEN-82 GENERATOR
2
Cleared 510(K)
K
89
0062
CADD-PCA MODEL 5800 AMBULATORY INFUSION PUMP
2
Cleared 510(K)
K
89
0457
MODIFIED MINIMED MDL404-SP/504-S DRUG INSULIN PUMP
2
Cleared 510(K)
K
88
3796
LIFECARE MICRO PUMP
2
Cleared 510(K)
K
88
2249
M.I.P. - PUMP
2
Cleared 510(K)
K
88
1759
BT-1 INFUSION PUMP
2
Cleared 510(K)
K
88
5083
INFUSA-PLATE(TM) EX
2
Cleared 510(K)
K
88
3993
MODIFIED IMED GEMINI PC-1 INFUSION PUMP
2
Cleared 510(K)
K
88
4014
FLO-GARD VP
2
Cleared 510(K)
K
88
3577
BARD INFUSOR PUMP
2
Cleared 510(K)
K
88
3587
BIOSEARCH 3600 ENTRI FEEDING PUMP
2
Cleared 510(K)
K
88
3653
EP-100 INFUSION PUMP
2
Cleared 510(K)
K
88
2598
250 ML BAG W/Y INJECT. & 12 EXTENSION SET
2
Cleared 510(K)
K
88
3902
INFUSA-PLATE
2
Cleared 510(K)
K
88
1079
UVP VOLUMED 2001
2
Cleared 510(K)
K
88
3003
MULTI-DRUG INFUSION SYSTEM
2
Cleared 510(K)
K
88
2594
THE OMNI-FLOW THERAPIST INFUSION MANAGEMENT SYSTEM
2
Cleared 510(K)
K
88
2556
BECTON DICKINSON PCA INFUSER - SOFTWARE MODIFI.
2
Cleared 510(K)
K
88
0857
SYRINGE PUMP MS2000
2
Cleared 510(K)
K
88
2159
522 INTELLIGENT PUMP
2
Cleared 510(K)
K
88
2102
PROVIDER ONE INFUSION SYSTEM
2
Cleared 510(K)
K
88
2107
PERFUSOR SECURA SYRINGE PUMP
2
Cleared 510(K)
K
88
2106
PERFUSOR M SYRINGE PUMP
2
Cleared 510(K)
K
88
2047
ENTRUST(TM) MODEL 800
2
Cleared 510(K)
K
88
0733
BARD PCA II INFUSION PUMP
2
Cleared 510(K)
K
88
1590
ADFUSE(TM)
2
Cleared 510(K)
K
87
5332
IVAC VOLUMETRIC PUMP - MODEL 590
2
Cleared 510(K)
K
87
5316
BIONICA MDS 110 PCA
2
Cleared 510(K)
K
87
4546
SIM MODULE
2
Cleared 510(K)
K
87
5365
MODEL 200A INFUSION PUMP
2
Cleared 510(K)
K
87
5348
MODEL 400A INFUSION PUMP
2
Cleared 510(K)
K
87
5347
MODEL 210A INFUSION PUMP
2
Cleared 510(K)
K
88
0479
IMED(R) GEMINI(TM) PC-1 VOLUMETRIC INFUSION PUMP
2
Cleared 510(K)
K
88
0204
CADD-TPA(TM) MODEL 5600 AMBULATORY INFUSION PUMP
2
Cleared 510(K)
K
88
0623
MINIMED MODEL 404-SP EXTERNAL INFUSION PUMP
2
Cleared 510(K)
K
88
0569
TEAMMATE(TM)
2
Cleared 510(K)
K
88
0625
HALF HOUR INFUSOR
2
Cleared 510(K)
K
87
5364
MODIFIED PCA INFUSER
2
Cleared 510(K)
K
87
5174
RATEMINDER V INFUSION PUMP
2
Cleared 510(K)
K
87
4181
BAXTER BEDSIDE SYSTEM
2
Cleared 510(K)
K
87
4564
MINIMED III INFUSION PUMP & UNI-SET ADMIN SET
2
Cleared 510(K)
K
87
4649
CADD-PLUS(TM) MODEL 5400 AMBULATORY INFUSION PUMP
2
Cleared 510(K)
K
87
3884
IVAC MODEL 560+ SERIES VOLUMETRIC INFUSION PUMP
2
Cleared 510(K)
K
87
3746
AUTO SYRINGE MODEL AS20G INFUSION PUMP
2
Cleared 510(K)
K
87
1881
MODEL 3000 INFUSION PUMP
2
Cleared 510(K)
K
87
2774
BETATRON IV SYSTEM
2
Cleared 510(K)
K
87
3494
RESERVOIR BAG
2
Cleared 510(K)
K
87
3495
PUMP TUBING SET
2
Cleared 510(K)
K
87
3961
INFUMED 300 AMBULATORY INFUSION PUMP
2
Cleared 510(K)
K
87
3522
BARD AMBULATORY PCA DRUG DELIVERY SYSTEM
2
Cleared 510(K)
K
87
2516
INFUSION PUMP MODEL 275
2
Cleared 510(K)
K
87
2514
INFUSION PUMP MODEL 270
2
Cleared 510(K)
K
87
2515
INFUSION PUMP MODEL 470
2
Cleared 510(K)
K
87
1807
BARD MICROINFUSER I INSULIN INFUSION PUMP
2
Cleared 510(K)
K
87
3938
IVAC(R) DUAL RATE SET - MODEL C50066
2
Cleared 510(K)
K
87
3847
CORMED III AMBULATORY INFUSION PUMP
2
Cleared 510(K)
K
87
3776
IVAC(R) STAR-FLOW(TM) VOLUMETRIC PUMP - MODEL 580+
2
Cleared 510(K)
K
87
3875
BAXA EXACTA-MED PHARMACY PUMP
2
Cleared 510(K)
K
87
3161
VALLEYLAB MODEL IV7200 INFUSION PUMP
2
Cleared 510(K)
K
87
2764
IVAC NITROGLYCERIN & LIPID ADMIN. SET MODEL S75053
2
Cleared 510(K)
K
87
3444
ENTECH ENTERAL PUMP AND SET
2
Cleared 510(K)
K
87
1806
PROVIDER IV. MODEL 5000 INFUSION DEVICE
2
Cleared 510(K)
K
87
2952
ULTRASONIC AIR-IN-LINE DETECTOR (AILD)
2
Cleared 510(K)
K
87
2741
NUTRIPUMP
2
Cleared 510(K)
K
87
0656
IMED(R) 980C VOLUMETRIC INFUSION PUMP
2
Cleared 510(K)
K
87
0801
FLO-GARD 6200 VOLUMETRIC INFUSION/PUMPING BLOOD
2
Cleared 510(K)
K
87
2850
RATE INFUSER SYSTEM
2
Cleared 510(K)
K
87
2821
INFUSION PUMP ENCLOSURE
2
Cleared 510(K)
K
87
1728
MODIFIED LIFECARE(R) 4100 PCA INFUSER
2
Cleared 510(K)
K
87
1084
NITROGLYCERINE PUMP SET
2
Cleared 510(K)
K
87
0330
SP55 SYRINGE PUMP
2
Cleared 510(K)
K
87
0991
IMED(R) MODEL 960A VOLUMETRIC INFUSION PUMP
2
Cleared 510(K)
K
87
0992
IMED(R) MODEL 965A VOLUMETRIC INFUSION PUMP
2
Cleared 510(K)
K
87
0524
AMBULATORY INFUSION PUMP DRUG RESERVOIR
2
Cleared 510(K)
K
87
0444
HOMEPRO II VOLUMETRIC INFUSION PUMP
2
Cleared 510(K)
K
87
0279
VP2000 INFUSION PUMP
2
Cleared 510(K)
K
86
4276
PERSONAL INFUSION PUMP
2
Cleared 510(K)
K
87
0768
AC ADAPTER ACCESSORY, PRODUCT CODE 600123A
2
Cleared 510(K)
K
87
0242
INTERMATE(TM)
2
Cleared 510(K)
K
86
4997
MEDTRAC VP VOLUMETRIC INFUSION PUMP
2
Cleared 510(K)
K
86
5051
GRASEBY PCAS MODEL NO. 0124-0701, PVS DYTINHR PUMP
2
Cleared 510(K)
K
86
4809
IVAC(R) STAR-FLOW(TM) VOLUMETRIC PUMP - MODEL 580
2
Cleared 510(K)
K
86
5060
I.V. SET WITH DUAL-CHANNEL CASSETTE
2
Cleared 510(K)
K
86
5059
I.V. SET W/SINGLE-CHANNEL CASSETTE
2
Cleared 510(K)
K
86
5058
ABBOTT LIFECARE (R) 5000, PUMP SYSTEM
2
Cleared 510(K)
K
86
3864
AMBULATORY INFUSION PUMP, MODEL AS30C
2
Cleared 510(K)
K
86
4808
STRATO(R) PCA INFUSER
2
Cleared 510(K)
K
86
4227
PERCUPUMP (TM)
2
Cleared 510(K)
K
86
3532
MODIFIED LABELING TO MODEL 2000 AMBULATORY INFUSER
2
Cleared 510(K)
K
86
4233
BARD HARVARD MINI-INFUSER 950 PUMP
2
Cleared 510(K)
K
86
3470
DALTEX IV INFUSION PUMP
2
Cleared 510(K)
K
86
4138
MINIMED MODEL 404-S EXTERNAL INFUSION PUMP
2
Cleared 510(K)
K
86
4517
MODEL 504-S EXTERNAL INFUSION PUMP FOR DIABETICS
2
Cleared 510(K)
K
86
3997
ABBOTT LIFECARE(R) 4100 PCA INFUSER
2
Cleared 510(K)
K
86
4106
SR-MODEL 230 (MODIFICATION)
2
Cleared 510(K)
K
86
3683
BARD HARVARD(TM) PCA JR INTERMITTENT INFUSION PUMP
2
Cleared 510(K)
K
86
2295
MODEL PC-2 VOLUMETRIC INFUSION PUMP/CONTROLLER
2
Cleared 510(K)
K
86
0353
SYRINGE INFUSION PUMP
2
Cleared 510(K)
K
86
2927
CADD-1, MODEL 5100 HF
2
Cleared 510(K)
K
86
1539
NIKKISO INFUSION PUMP MODEL PFA-02
2
Cleared 510(K)
K
86
1598
INTELLIGRAPH(TM) PROGRAMMER
2
Cleared 510(K)
K
86
1207
INTELLIJECT INFUSION PUMP
2
Cleared 510(K)
K
86
1208
INTELLIJECT MEDICATION SYRINGE
2
Cleared 510(K)
K
86
1209
STREAM-SWITCH MANIFOLD
2
Cleared 510(K)
K
86
1040
ENTERNAL INFUSER MULTIPUMP 203
2
Cleared 510(K)
K
86
1001
PARENTERAL INFUSER MEDIPUMP 204
2
Cleared 510(K)
K
86
1436
SOF SET, MODELS 111 AND 112
2
Cleared 510(K)
K
86
1324
PATIENTCARE 1000
2
Cleared 510(K)
K
86
0222
70 ML RESERVOIR BAG AND ADMINISTRATION SETS
2
Cleared 510(K)
K
86
0857
SOF SET, MODELS 113 AND 114
2
Cleared 510(K)
K
86
1007
BECTON DICKINSON PCAINFUSER
2
Cleared 510(K)
K
86
0969
FLUID MANAGEMENT SYSTEM (MODIFIED)
2
Cleared 510(K)
K
86
0694
IV7200 AND IV7400 INFUSION PUMP
2
Cleared 510(K)
K
86
0162
FLO-GARD 6200 VOLUMETRIC INFUSION PUMP
2
Cleared 510(K)
K
86
0229
MODEL 900 INFUSION PUMP
2
Cleared 510(K)
K
86
0218
SYRINGE PUMP: VM 07
2
Cleared 510(K)
K
86
0086
ENTERAL NUTRITION PUMPS PN 1000 AND VM 05
2
Cleared 510(K)
K
85
4318
LIFEPORT AMBULATORY INFUSION PUMP
2
Cleared 510(K)
K
85
3664
HEPARIN MICRO-INFUSOR
2
Cleared 510(K)
K
85
2168
ELECTRONIC COMMUNICATION SYS ACCESSORY FOR GRAVITY
2
Cleared 510(K)
K
85
4964
CADD-LD 5500 AMBU INFUSION PUMP&3010 10ML MED RES.
2
Cleared 510(K)
K
86
0502
G.A.S./GRIESHABER AIR SYSTEM
2
Cleared 510(K)
K
85
5215
AIR/FLUID EXCHANGE SYSTEM
2
Cleared 510(K)
K
86
0492
NORDISK INFUSER SYSTEM WITH PRE-FILLED CARTRIDGE
2
Cleared 510(K)
K
85
4157
PMT ACCUPRESSURE INFUSION SYSTEM 3601
2
Cleared 510(K)
K
85
3629
BARD HARVARD CHRONOFUSOR TIME-DOSE SYRINGE INFUSIO
2
Cleared 510(K)
K
85
3814
MP0400 ADULT, PERISTALIC INFUSION PUMP
2
Cleared 510(K)
K
85
4074
MODEL 200 INFUSION PUMP
2
Cleared 510(K)
K
85
4073
MODEL 210 INFUSION PUMP
2
Cleared 510(K)
K
85
2645
FLUID MANAGEMENT SYSTEM
2
Cleared 510(K)
K
85
3881
THE TRAVENOL 5 ML/HR INFUSOR
2
Cleared 510(K)
K
85
3393
INSULIN PUMP INSUMAT 229
2
Cleared 510(K)
K
85
0792
ODAC-ON DEMAND ARALGESIA BY COMPUTER-INFUSION PUMP
2
Cleared 510(K)
K
85
3584
CADD-1, MODEL 5100 HF, AMBULATORY INFUSION PUMP
2
Cleared 510(K)
K
85
3134
NATIONAL MED CARE INFUSION PUMP ADM SET #95-0001-8
2
Cleared 510(K)
K
84
2905
TRAVENOL MULTIDAY INFUSOR 2C1080
2
Cleared 510(K)
K
85
2965
ENTERAL FEEDING PUMP
2
Cleared 510(K)
K
85
2358
SYRINGE INFUSION PUMP - AS 20 SERIES
2
Cleared 510(K)
K
85
1821
VI-FLOW PUMP WITH VI-SET
2
Cleared 510(K)
K
85
2073
VIAL SYRINGE PUMPS, SE200, SE200B & SE400
2
Cleared 510(K)
K
85
2060
INFUSION SETS MODELS 9120,9121,9125, 9122 & 9123
2
Cleared 510(K)
K
85
1564
MODEL 2000 INDULIN INFUSION PUMP
2
Cleared 510(K)
K
85
1351
ENTERAL FEEDING PUMP
2
Cleared 510(K)
K
85
0997
UVP 2000 VOLUMED -TENTATIVE
2
Cleared 510(K)
K
85
1360
IMED GRAVISET INTRAVASCULAR ADMIN. SET
2
Cleared 510(K)
K
85
1447
IVAC MODEL 580 GENER. USE VOLUMETRIC INFUSION PUMP
2
Cleared 510(K)
K
85
1017
QUEST 521 VARIABLE PRESSURE VOLUMETRIC INFUSION PU
2
Cleared 510(K)
K
85
0729
ACUFLO VOLUMETRIC CONTROLLED DELIVERY SYS 2000
2
Cleared 510(K)
K
85
0674
CORMED II AMBULATORY INFUSION PUMP
2
Cleared 510(K)
K
85
0669
PROMINJECT PROGRAMMABLE INFUSION PUMP
2
Cleared 510(K)
K
85
0653
IMED 440 INFUSION PUMP & ADMINISTRATION SET
2
Cleared 510(K)
K
85
0488
STRATOFUSE SYRINGE PIGGYBACK PUMP 1030
2
Cleared 510(K)
K
85
0183
CADD-VT, 5300 AMBULATORY INFUSION PUMP W/3050, 50M
2
Cleared 510(K)
K
84
3311
IV ADMIN. SET FOR MVP 1 INFUSION PUMP
2
Cleared 510(K)
K
84
4401
REPRO-MED SYSTEMS INFUSION DEVICE
2
Cleared 510(K)
K
84
4915
IMED 980 VOLUMETRIC INFUSION PUMP
2
Cleared 510(K)
K
85
0098
SILVER SPOON ENTERAL FEEDING PUMP
2
Cleared 510(K)
K
84
1374
HOME PRO VOLUMETRIC INFUSION PUMP
2
Cleared 510(K)
K
84
4730
BARD HARVARD MINI-INFUSER 400 MULTI DOSE SYRINGE
2
Cleared 510(K)
K
84
4719
360 INFUSER
2
Cleared 510(K)
K
84
4718
MODEL 1001
2
Cleared 510(K)
K
84
4627
STRATOFUSE SYRINGE PIGGYBACK PUMP
2
Cleared 510(K)
K
84
4768
ABBOTT LIFECARE 500 INFUSER
2
Cleared 510(K)
K
84
4091
ABBOTT LIFECARE 900 VOLUMETRIC PUMP
2
Cleared 510(K)
K
84
4851
MINIMED EXTERNAL INFUSION PUMP FOR DIAGETICS 504
2
Cleared 510(K)
K
84
4792
MINIMED EXTERNAL INFUSION PUMP FOR DIABETICS 502A
2
Cleared 510(K)
K
84
4078
PROVIDER PA 3000 INFUSION SYSTEM
2
Cleared 510(K)
K
84
3878
HEPARIN INFUSIN PUMP
2
Cleared 510(K)
K
84
3773
CADD-PAC 5200 AMBULATORY INFUSION PUMP
2
Cleared 510(K)
K
84
3772
CADD-1 5100 AMBULATORY INFUSION PUMP
2
Cleared 510(K)
K
84
3949
I.V. PUMP ADMINISTRATION SET
2
Cleared 510(K)
K
84
3331
INTERMEDICS/GRASEBY DYNAMICS MS 36
2
Cleared 510(K)
K
84
2479
I.V. TEAMATE
2
Cleared 510(K)
K
84
3616
AVI GUARDIAN 400 INFUSION PUMP
2
Cleared 510(K)
K
84
3615
AVI GUARDIAN MICRO 410 INFUSION PUMP
2
Cleared 510(K)
K
84
3548
INTERMEDICS SYRINGE PUMP 710-02
2
Cleared 510(K)
K
84
3168
ENTERAL FEEDING PUMP 14-800 SERIES
2
Cleared 510(K)
K
84
3274
MODULAR VOLUMETRIC INFUSION PUMP SYS
2
Cleared 510(K)
K
84
2568
RADIONUCLIDE INFUSION SYSTEM
2
Cleared 510(K)
K
84
2421
ARGYLE ENTERITE ENTERAL FEEDING PUMP
2
Cleared 510(K)
K
84
1827
ENTEROPORT NUTRITION PUMP
2
Cleared 510(K)
K
84
2289
SR- MODEL 230
2
Cleared 510(K)
K
84
2263
MTP E.V. INFUSION PUMP
2
Cleared 510(K)
K
84
2027
IVAC 3080 ENTERAL FEEDING PUMP
2
Cleared 510(K)
K
84
1922
ACCUPRO VOLUMETRIC INFUSION PUMP W/RS232
2
Cleared 510(K)
K
84
1784
FLEXIFLO-III PORTABLE ENTERAL NUTRI
2
Cleared 510(K)
K
84
1630
ENTERAL NUTRITION PUMP
2
Cleared 510(K)
K
84
1729
ACCUPRO ENTERAL FEEDING PUMP
2
Cleared 510(K)
K
84
1512
ETHOX RELIA-FLO 2001 ENTERAL FEED
2
Cleared 510(K)
K
84
1481
WINDSOR MEDICAL MODEL 50-00002
2
Cleared 510(K)
K
84
1373
PROVIDER IV MODEL 2000 INFUSIN SYS
2
Cleared 510(K)
K
84
1017
PROVIDER INFUSION SET
2
Cleared 510(K)
K
83
3983
PROVIDER U-100 INSULIN INFUSION SYS
2
Cleared 510(K)
K
84
1018
PANCRETEC PUMP CHECK
2
Cleared 510(K)
K
84
0616
MINI-PUMP U-100
2
Cleared 510(K)
K
83
2470
INFUSION PUMP
2
Cleared 510(K)
K
84
0263
LIFECARE 4/HOMECARE - 4H PUMP
2
Cleared 510(K)
K
83
4461
INFUSION PUMP PRIMER
2
Cleared 510(K)
K
83
3723
MODEL 2000 AMBULATORY MED. INFUSER
2
Cleared 510(K)
K
83
3958
FLO-GARD 8100 INFUSION PUMP
2
Cleared 510(K)
K
83
3655
GILLETTE SABRE SYRINGE
2
Cleared 510(K)
K
83
2285
VOLUMETRIC PUMP SET 2C9100 FOR NITROGLY
2
Cleared 510(K)
K
83
2606
WINDSOR MEDICAL VARIOUS MODELS
2
Cleared 510(K)
K
83
3306
BETATRON I AMBULATORY INSULIN PUMP
2
Cleared 510(K)
K
83
2350
INTRABIONIC CO. - MICRO SYRINGE
2
Cleared 510(K)
K
83
2349
PROGRAMED
2
Cleared 510(K)
K
83
2923
AMBULATORY INSULIN INFUSION PUMP
2
Cleared 510(K)
K
83
2755
INFUSION PUMP & IV SETS #4000
2
Cleared 510(K)
K
83
2641
WINDSOR MEDICAL MODEL 52
2
Cleared 510(K)
K
83
0657
AMBULATORY MARK XI DRUG INFUSION DEV-
2
Cleared 510(K)
K
83
2410
GRASEBY DYNAMICS MS302 SYRINGE DRIVER
2
Cleared 510(K)
K
83
2289
LIFECARE MICRO PUMP
2
Cleared 510(K)
K
83
1534
PUMPETTE AS8P-INFUSION PUMP
2
Cleared 510(K)
K
83
1444
SINGLE USE SYRINGE #103 PERSONAL MEDIC
2
Cleared 510(K)
K
83
0389
ACCU-RYNGE PUMP SP-250
2
Cleared 510(K)
K
83
2166
FLO-GARD 8500 MICROINFUSION PUMP
2
Cleared 510(K)
K
83
2167
CORPAK VTR 300 ENTERNAL PUMP
2
Cleared 510(K)
K
83
0656
AMBULATORY MARK III INFUSION DEVICE
2
Cleared 510(K)
K
83
2120
PROMINJET PUMP
2
Cleared 510(K)
K
83
2008
INFUTROL 7000 INFUSION PUMP
2
Cleared 510(K)
K
83
1897
BETA I PROGRAMMABLE INFUSION PUMP
2
Cleared 510(K)
K
83
1761
SIMPLICITY PLUS
2
Cleared 510(K)
K
83
1935
ENTERNAL PUMP & ADMIN. SET 430
2
Cleared 510(K)
K
83
1258
FLO-GARD 6100 VOLUMETRIC INFUSION PUMP
2
Cleared 510(K)
K
83
0906
PULSAMAT MODEL 1050
2
Cleared 510(K)
K
83
1203
Y-TYPE BACKCHECK MICROBORE EXTEN. SET
2
Cleared 510(K)
K
83
1259
RESERVOIR 1.5CC #9210 W/25 GAUGE/NEEDLE
2
Cleared 510(K)
K
83
0809
GRASE BY DYNAMICS MS 27 SYRINGE DRIVER
2
Cleared 510(K)
K
83
0452
PCA PUMP
2
Cleared 510(K)
K
83
0486
INFUSION PUMP #AS*6H
2
Cleared 510(K)
K
83
0936
TREONIC IP5
2
Cleared 510(K)
K
83
0605
PUMP PALL AMBULATORY INSULIN INFUSION
2
Cleared 510(K)
K
83
0544
WINDSOR MEDICAL, INC. 50-01-028
2
Cleared 510(K)
K
83
0454
IMS MINIATURE VOLUMETRIC INFUSION PUMP
2
Cleared 510(K)
K
83
0490
MODEL 50-01-27
2
Cleared 510(K)
K
83
0570
PERSONAL MEDICATION INFUSER
2
Cleared 510(K)
K
82
2842
AMBULATORY MARK I
2
Cleared 510(K)
K
83
0423
SYRINGE DRIVER MS-16
2
Cleared 510(K)
K
83
0355
SECURA IV VOLUMETRIC INFUSION PUMP
2
Cleared 510(K)
K
83
0102
HARVARD APPARATUS INTERMITTENT INFUSION
2
Cleared 510(K)
K
83
0151
EXTERNAL INFUSION PUMP
2
Cleared 510(K)
K
83
0177
HARVARD APPARATUS FAMILY OF FLUID INFUS
2
Cleared 510(K)
K
83
0038
SIGMA 7000-6000 INFUSION PUMPS
2
Cleared 510(K)
K
82
0038
SIGMA 7000
2
Cleared 510(K)
K
83
0017
VOLUMETRIC PUMP ADMIN. SETS
2
Cleared 510(K)
K
82
3406
GUARDIAN 110, VOL. CONTROL DELIV. SYS
2
Cleared 510(K)
K
82
3204
BETATRON II
2
Cleared 510(K)
K
82
3193
AMBULATORY INSULIN INFUSION PUMP 9205
2
Cleared 510(K)
K
82
3063
FLO-GARD 2000 ENTERNAL PUMP & TRAVASORB
2
Cleared 510(K)
K
82
3035
COMPUTER INTERFACE MODULE CIM
2
Cleared 510(K)
K
82
2989
HARVARD APPARATUS SINGLE SPEED SYRINGE
2
Cleared 510(K)
K
82
2454
SYRINGE PUMP 209-100
2
Cleared 510(K)
K
82
2571
SYRINGE PUMP
2
Cleared 510(K)
K
82
2761
DELIVERY TUBE SET #2226
2
Cleared 510(K)
K
82
1661
FLEXIFLO-II
2
Cleared 510(K)
K
82
1069
MODEL AS6M INFUSION PUMP
2
Cleared 510(K)
K
82
1148
ETHOX FOOD PUMP STAND W/POLE CLAMP
2
Cleared 510(K)
K
82
1047
IVAC 630 & VOLUMETRIC INFUSION PUMP
2
Cleared 510(K)
K
82
0946
AS 70 VOLUMETRIC INFUSION PUMP
2
Cleared 510(K)
K
82
0860
VOLUMETRIC PUMP CASSETTE W/ATTACHED SET
2
Cleared 510(K)
K
82
0764
IVAC MODEL 160 AIR-IN-LINE SENSOR
2
Cleared 510(K)
K
82
0726
ACCUSET (R) CASSETTE
2
Cleared 510(K)
K
82
0482
ACCU-RYNGE INSULIN PUMP #SP-250
2
Cleared 510(K)
K
81
3644
MODEL 2650 HIGH CAPACITY DUAL SYRINGE
2
Cleared 510(K)
K
82
0219
OPEN LOOP INFUSION PUMP
2
Cleared 510(K)
K
82
0063
KEOFEED 500 ENTERIC FEEDING PUMP
2
Cleared 510(K)
K
81
3562
SYRINGE DRIVER 209
2
Cleared 510(K)
K
81
3590
MODEL AS6B INFUSION PUMP
2
Cleared 510(K)
K
82
0073
OPEN LOOP AMBULATORY INSULIN INFUSION
2
Cleared 510(K)
K
81
3473
5B SLAVE MODULE SYRINGE PUMP
2
Cleared 510(K)
K
81
3455
PUMP & DETECTOR
2
Cleared 510(K)
K
81
3403
FLO-GARD 8000 INFUSION PUMP SYSTEM
2
Cleared 510(K)
K
81
2898
PE-01 ELECTRONIC INFUSION PUMP
2
Cleared 510(K)
K
81
2917
PORTABLE LIDOCAINE INFUSION PUMP
2
Cleared 510(K)
K
81
0850
PERSONAL MEDICATION INFUSER
2
Cleared 510(K)
K
81
2824
PRESSURE DISC COMPONENT FOR ACCUSET
2
Cleared 510(K)
K
81
2823
IMED MODEL 970 & 975 VOL. INFUSION PUMP
2
Cleared 510(K)
K
81
2499
INFUSION PUMP
2
Cleared 510(K)
K
81
2442
3M INFUSION SYSTEM
2
Cleared 510(K)
K
81
1783
ENDOPUMP
2
Cleared 510(K)
K
81
2339
TERUFUSION INFUSION PUMP MODEL STC-502
2
Cleared 510(K)
K
81
2042
INFUSION PUMP MODEL 200/201
2
Cleared 510(K)
K
81
2021
VOLUMETRIC INFUSION PUMP
2
Cleared 510(K)
K
81
2035
IMED ACCUSET CASSETTE
2
Cleared 510(K)
K
81
1917
I.V. ADMIN. SETS FOR THE AMP MARK IV PMP
2
Cleared 510(K)
K
81
1933
GUARDIAN, VOLUMETRIC CONTROL DELIVERY
2
Cleared 510(K)
K
81
1918
AMP MARK IV INFUSION PUMP
2
Cleared 510(K)
K
81
1884
IVAC 700 SYRINGE INFUSION PUMP
2
Cleared 510(K)
K
81
1774
OPEN LOOP AMBULATORY INFUSION DEVICE
2
Cleared 510(K)
K
81
1739
ENTRI ENTERAL FEEDING PUMP
2
Cleared 510(K)
K
81
1272
RAZEL MODEL C
2
Cleared 510(K)
K
80
3183
OFFENBACK REVERSIBLE BARIUM PUMP
2
Cleared 510(K)
K
81
1238
MODEL 560 SERIES VOLUMETRIC INFUSION
2
Cleared 510(K)
K
81
0295
COMPUTER INTERFACE MODULE
2
Cleared 510(K)
K
81
0252
STUMARK INFUSOR
2
Cleared 510(K)
K
80
3078
SIMPLICITY INFUSION PUMP MODEL 2100A
2
Cleared 510(K)
K
80
3190
ETHOX/BARRON #2000 FOOD PUMP-ENTERAL FED
2
Cleared 510(K)
K
80
2901
TRAVENOL INFUSION PUMP-2M8016
2
Cleared 510(K)
K
80
2400
MS 16 SYRINGE DRIVER
2
Cleared 510(K)
K
80
2820
TRAVENOL 24 HR. INFUSOR (ELASTOMERIC PP)
2
Cleared 510(K)
K
80
2301
CORDIS DOW INFUSION PUMP
2
Cleared 510(K)
K
80
1904
SYRINGE INFUSION PUMP #2716
2
Cleared 510(K)
K
80
1546
THE SIMPLICITY PUMP #2100 INFUSION PUMP
2
Cleared 510(K)
K
80
1725
KANGAROO ENTERAL FEEDING PUMP
2
Cleared 510(K)
K
80
1704
OPEN-LOOP INSULIN DELIVERY SYSTEM
2
Cleared 510(K)
K
80
1441
ABBOTT/SHAW LIFE CARE PUMP MODEL 3
2
Cleared 510(K)
K
80
0627
AMBULATORY INFUSION PUMP, CODE 2M9807
2
Cleared 510(K)
K
80
0629
INTRAVENOUS INFUSION PUMP, CODE 2M8015
2
Cleared 510(K)
K
80
0570
HEPARIN PUMP #7420
2
Cleared 510(K)
K
80
0569
SYRINGE INFUSION PUMP #2720
2
Cleared 510(K)
K
79
2050
3M SMALL VOLUME INFUSTION (SVI) SYSTEM
2
Cleared 510(K)
K
79
2142
MODEL IV 6500 FORMULATOR
2
Cleared 510(K)
K
79
1293
BATTERY POWERED SYRINGE INFUSION PUMP
2
Cleared 510(K)
K
79
1720
AR/MDE INFUSOR MODEL 60/2 INFUSION PUMP
2
Cleared 510(K)
K
79
1729
SYRINGE INFUSION PUMP
2
Cleared 510(K)
K
79
1528
FLEXIFO ENTERAL NUTRITION PUMP
2
Cleared 510(K)
K
79
0814
DELTA PUMP
2
Cleared 510(K)
K
79
0945
MODEL 113 TREONIC IP3 DIGITAL SYRINGE PU
2
Cleared 510(K)
K
79
0559
ALARM
2
Cleared 510(K)
K
79
0315
BLOOD CELL SEPARATOR SYSTEM CS3000
2
Cleared 510(K)
K
79
0373
IVAC 630 VOLUMETRIC INFUSION PUMP
2
Cleared 510(K)
K
79
0332
MODEL IV6000 INFUSION PUMP
2
Cleared 510(K)
K
78
2034
INFUSION PUMP, MODEL AS*5
2
Cleared 510(K)
K
78
2019
CUTTER 888-00 INFUSION PUMP
2
Cleared 510(K)
K
78
2020
INFUSION PUMP, MODEL 5000
2
Cleared 510(K)
K
78
1171
INFUSION PUMP, PEDIATRIC MODEL 301
2
Cleared 510(K)
K
78
0705
INFUSION PUMP-MODEL 2616
2
Cleared 510(K)
K
78
0503
INFUSION PUMP
2
Cleared 510(K)
K
78
0086
INFUSION APPARATUS, POWERED
2
Cleared 510(K)
K
77
2094
LIFECARE I.V. PUMP - MODEL III
2
Cleared 510(K)
K
77
1300
INTRAVENOUS INFUSION PUMP
2
Cleared 510(K)
K
77
1664
VOLUMETRIC INFUSION PUMP MODEL 960
2
Cleared 510(K)
K
77
1478
INFUSION PUMP #6202
2
Cleared 510(K)
K
77
0849
VOLUMET INFUSION PUMP, MODIFI. OF
2
Cleared 510(K)
K
77
0730
PUMP, INFUSION, DYNATECH/HANDLEY
2
Cleared 510(K)
K
77
0087
I.V. PUMP, ABBOTT/SHAW LIFECARE
2
Cleared 510(K)
K
76
1307
AUTO SYRINGE MODEL AS-3A
2
Cleared 510(K)
K
76
1151
INFUSION PUMP
2
Cleared 510(K)
K
76
0718
PERISTALTIC INFUSION PUMP (2100,2101)
2
Cleared 510(K)
K
76
0370
INFUSION EQUIPMENT, INTRAVENOUS
2
Cleared 510(K)
FRP
Holder, Infant Position
1
Product Code
FRR
Chamber, Reverse Isolation, Patient Care
2
Product Code
FSA
Lift, Patient, Non-Ac-Powered
1
Product Code
FSD
Binder, Abdominal
1
Product Code
HEF
Binder, Breast
1
Product Code
HFS
Shield, Nipple
1
Product Code
IKY
Mattress, Flotation Therapy, Non-Powered
1
Product Code
KMK
Device, Intravascular Catheter Securement
1
Product Code
KMO
Binder, Elastic
1
Product Code
KPE
Container, I.V.
2
Product Code
KYP
Snake Bite Suction Kit
1
Product Code
KYQ
Kit, Chemical Snake-Bite
3
Product Code
KZD
Infusor, Pressure, For I.V. Bags
1
Product Code
KZE
Injector, Fluid, Non-Electrically Powered
2
Product Code
LBI
Unit, Neonatal Phototherapy
2
Product Code
LDR
Controller, Infusion, Intravascular, Electronic
2
Product Code
LGM
Chamber, Patient Isolation
2
Product Code
LGN
Chamber, Patient Transport Isolation
2
Product Code
LGZ
Warmer, Thermal, Infusion Fluid
2
Product Code
LHF
Warmer, Microwave, Infusion Fluid
2
Product Code
LHI
Set, I.V. Fluid Transfer
2
Product Code
LJL
Detectors And Removers, Lice, (Including Combs)
1
Product Code
LJS
Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
2
Product Code
LJT
Port & Catheter, Implanted, Subcutaneous, Intravascular
2
Product Code
LLI
Bed, Therapeutic, Ac-Powered, Adjustable Home-Use
2
Product Code
LLK
Legging, Compression, Non-Inflatable
2
Product Code
LZH
Pump, Infusion, Enteral
2
Product Code
MDR
Binder, Medical, Therapeutic
1
Product Code
MEA
Pump, Infusion, Pca
2
Product Code
MEB
Pump, Infusion, Elastomeric
2
Product Code
MEG
Syringe, Antistick
2
Product Code
MHC
Needle, Interosseous
2
Product Code
MHD
Pump, Infusion, Gallstone Dissolution
2
Product Code
MJF
Check Valve, Retrograde Flow (In-Line)
2
Product Code
MMK
Container, Sharps
2
Product Code
MQX
Needle, Acupuncture, Single Use
2
Product Code
MRZ
Accessories, Pump, Infusion
2
Product Code
MZR
Topical Approximation System
1
Product Code
NEP
System/Device, Pharmacy Compounding
2
Product Code
NGT
Saline, Vascular Access Flush
2
Product Code
NKK
Needle, Hypodermic, Single Lumen, Reprocessed
2
Product Code
NKN
Syringe, Piston, Reprocessed
2
Product Code
NRW
Stimulator, Intramuscular, Automatic
2
Product Code
NSC
Injector, Pen
2
Product Code
NTC
Nursing Pad, Hydrogel
1
Product Code
NTX
Nursing Pad, Polyurethane Pad With Starch Copolymer, Glycerin, And Surfactant (F-68)
1
Product Code
NXH
Nursing Pad, Cohesive Gel
1
Product Code
NZG
Bassinet, Hospital
2
Product Code
NZW
Heparin, Vascular Access Flush
2
Product Code
NZX
Water, Vascular Access Flush
2
Product Code
OBK
Port, Protector/Cushion
2
Product Code
ODI
Administration Set Docking Station
2
Product Code
ODY
Tunneled Catheter Remover
2
Product Code
OJA
Intravenous Extension Tubing Set
2
Product Code
OKC
Implanted Subcutaneous Securement Catheter
2
Product Code
OKE
Port Introducer Kit
2
Product Code
OKL
Intravascular Administration Set, Automated Air Removal System
2
Product Code
OMF
Percutaneous, Implanted, Long-Term Intravascular Catheter Accessory For Catheter Position
2
Product Code
ONB
Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System
2
Product Code
ONM
Radiant Infant Warmer Cabinet
2
Product Code
PUK
Administration Set Securement Device
1
Product Code
OPP
Pump, Infusion, Insulin Bolus
2
Product Code
OSI
Bariatric Bed
2
Product Code
OUW
Infant Positioner, Rx, Use In Highly Monitored Setting
1
Product Code
OWL
Peripheral Catheter Insertion Kit
2
Product Code
PDH
Blanket, Neonatal Phototherapy
2
Product Code
PEF
Heparin Flush In 0.45% Sodium Chloride
2
Product Code
PEZ
Central Venous Catheter Dressing Change Kit
2
Product Code
PHC
Infusion Safety Management Software
2
Product Code
PKP
Immunoglobulin G (Igg) Infusion System
2
Product Code
PMS
Peripheral Intravenous (Piv) Infiltration Monitor
2
Product Code
PND
Midline Catheter
2
Product Code
POQ
Blood Transfusion Kit
2
Product Code
POR
Parenteral Administration Kit
2
Product Code
PQH
Iodinated Contrast Media Transfer Tubing Set
2
Product Code
PQX
Epinephrine Syringe
2
Product Code
PRN
Pediatric Position Holder
1
Product Code
PTD
Subcutaneous Implanted Apheresis Port
2
Product Code
PTI
Non-Coring (Huber) Needle
2
Product Code
PUN
Lice Removal Kit Containing A Solution
1
Product Code
PUR
Vacuum Syringe
2
Product Code
PVZ
Non-Stainless Steel Needle
2
Product Code
PWH
Administrations Sets With Neuraxial Connectors
2
Product Code
PWN
Baby Care Kit
2
Product Code
PWO
Blood Administration Kit
2
Product Code
PWQ
Buret Administration Intravenous Kit
2
Product Code
PWR
Catheter Repair Kit
2
Product Code
PWX
Insect Sting Emergency Kit
1
Product Code
PWY
Lumbar Puncture Tray (Adult & Pediatric)
2
Product Code
PXB
Percutaneous Introducer Kit
2
Product Code
PXI
Thoracentesis Tray
2
Product Code
PXJ
Umbilical Catheter Insertion Tray
2
Product Code
PXK
Vascular Access Port Kit
2
Product Code
PXL
Venipuncture Kit
2
Product Code
PYR
Neuraxial Administration Set - Intrathecal Delivery
2
Product Code
PZW
Catheter Access Cover, Tamper-Resistant
2
Product Code
QBL
Piston Syringe Lever
2
Product Code
QDM
Midazolam Syringe
2
Product Code
QEH
Piston Syringe With Neuraxial Connector – Epidural, Peripheral, And/Or Indirect Cerebral Spinal Fluid Contact
2
Product Code
QJY
Infusion Pump, Drug Specific, Pharmacy-Filled
2
Product Code
QLF
On-Body Injector
2
Product Code
QLY
Ophthalmic Syringe
2
Product Code
QMT
Prep Kit – Vaccine Injection
2
Product Code
QNQ
Low Dead Space Piston Syringe
2
Product Code
QNS
Low Dead Space Needle, Single Lumen, Hypodermic
2
Product Code
QOG
Injection Data Capture Device
2
Product Code
QOI
Intravenous Catheter Force-Activated Separation Device.
2
Product Code
QTI
Saline Vascular Access Flush With Integrated Alcohol Disinfectant Device
2
Product Code
QYM
Ophthalmic Needle
2
Product Code
SCL
Allergen And Vaccine Delivery Needles
2
Product Code
SEF
Central Venous Catheter With Manual Insertion System
2
Product Code
Subpart F—Neurological Therapeutic Devices
CFR Sub-Part
Subpart F—Physical Medicine Therapeutic Devices
CFR Sub-Part
Subpart F—Therapeutic Devices
CFR Sub-Part
Subpart G—General Hospital and Personal Use Miscellaneous Devices
CFR Sub-Part
Subpart G—Miscellaneous Devices
CFR Sub-Part
Hematology
Review Panel
Immunology
Review Panel
Microbiology
Review Panel
Neurology
Review Panel
Obstetrical and Gynecological
Review Panel
Ophthalmic
Review Panel
Orthopedic
Review Panel
Pathology
Review Panel
Physical Medicine
Review Panel
Radiology
Review Panel
General and Plastic Surgery
Review Panel
Toxicology
Review Panel
Medical Genetics
Review Panel
Unknown
Review Panel
Last synced on 2 May 2025 at 11:05 pm
HO
/
subpart-f—general-hospital-and-personal-use-therapeutic-devices
/
FRN
/
K223607
View Source
Plum Duo™ Infusion System
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K223607
510(k) Type
Traditional
Applicant
ICU Medical, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
8/24/2023
Days to Decision
265 days
Submission Type
Summary
FDA Browser
by
Innolitics
Anesthesiology
Cardiovascular
Chemistry
Dental
Ear, Nose, Throat
Gastroenterology and Urology
General Hospital
Miscellaneous
Subpart B—Cardiovascular Diagnostic Devices
Subpart B—Diagnostic Devices
Subpart C—Cardiovascular Monitoring Devices
Subpart C—General Hospital and Personal Use Monitoring Devices
Subpart D—Pathology Instrumentation and Accessories
Subpart D—Prosthetic Devices
Subpart E—Surgical Devices
Subpart F—General Hospital and Personal Use Therapeutic Devices
BRZ
Set, Blood Transfusion
BWJ
Locator, Acupuncture Point
CAK
Microfilter, Blood Transfusion
DWL
Stocking, Medical Support (To Prevent Pooling Of Blood In Legs)
FMF
Syringe, Piston
FMG
Stopcock, I.V. Set
FMI
Needle, Hypodermic, Single Lumen
FMS
Bed, Pediatric Open Hospital
FMT
Warmer, Infant Radiant
FMZ
Incubator, Neonatal
FNG
Lift, Patient, Ac-Powered
FNJ
Bed, Manual
FNK
Bed, Hydraulic, Adjustable Hospital
FNL
Bed, Ac-Powered Adjustable Hospital
FNM
Mattress, Air Flotation, Alternating Pressure
FNN
Nipple, Lambs Feeding
FOD
Device, Occlusion, Umbilical
FOH
Mattress, Water, Temperature Regulated
FOK
Pad, Neonatal Eye
FOS
Catheter, Umbilical Artery
FOZ
Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
FPA
Set, Administration, Intravascular
FPB
Filter, Infusion Line
FPK
Tubing, Fluid Delivery
FPL
Incubator, Neonatal Transport
FQH
Lavage, Jet
FQJ
Support, Scrotal, Therapeutic
FQK
Binder, Perineal
FQL
Stocking, Medical Support (For General Medical Purposes)
FQM
Bandage, Elastic
FRF
Cleaner, Air, Medical Recirculating
FRL
Fiber, Medical, Absorbent
FRN
Pump, Infusion
K
24
2115
Plum Duo™ Precision IV Pump
K
24
2114
Plum Solo™ Precision IV Pump
K
25
0357
RemunityPRO™ Pump for Remodulin® (treprostinil) Injection
K
24
1736
Remunity 2.0 Pump for Remodulin (treprostinil) Injection
K
24
2735
Belmont Rapid Infuser, RI-2 (Rapid Infuser RI-2, 1000 ml/min); Belmont Rapid Infuser, RI-2 (Rapid Infuser RI-2, 750 ml/min)
K
24
2660
Curlin 8000 Ambulatory Infusion System; Enterprise Solution (ES) Software; Curlin 380-series Administration Sets
K
24
2390
Novum IQ Syringe Pump (40800BAXUS)
K
23
2793
Curlin 8000 Ambulatory Infusion System; Enterprise Solution (ES) Software; Curlin 380-Series Adminstration Sets
K
21
1122
Novum IQ Large Volume Pump
K
23
1918
Freedom60 Infusion Pump; High-Flo Subcutaneous Needle Sets; Precision Flow Rate Tubing; High-Flo Super26 Subcutaneous Needle Sets; Freedom60 Pre-Filled Syringe Adapter
K
23
0083
SAFIRA
K
22
3607
Plum Duo™ Infusion System
K
21
1218
BD Alaris System with Guardrails Suite MX v12.1.2
K
23
0041
Spectrum IQ Infusion System with Dose IQ Safety Software
K
23
0022
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library
K
21
3744
Avoset Infusion Pump System
K
22
2048
Spectrum IQ Infusion System with Dose IQ Safety Software
K
21
1125
Novum IQ Syringe Pump
K
22
0417
Spectrum IQ Infusion System with Dose IQ Safety Software
K
21
4045
FreedomEdge Syringe Infusion System
K
21
0073
Agilia VP Infusion System, Agilia VP MC WIFI Infusion Pump, Volumat Lines Administration Sets, Agilia Link, Agilia Duo
K
21
0074
Agilia SP Infusion System, Agilia SP MC WIFI Infusion Pump, Agilia Link, Agilia Duo, Agilia USB Cable
K
20
0176
FREEDOM Integrated Syringe Infusion System
K
21
1206
FreedomEdge(R) Syringe Infusion System
K
19
2860
Sapphire Infusion Pump, Sapphire administration sets
K
18
3311
Ivenix Infusion System (IIS)
K
19
0182
Unity Subcutaneous Delivery System for Remodulin
K
17
2653
Power Infuser
K
17
2831
Perfusor® Space Syringe Infusion Pump System
K
17
3084
Spectrum IQ Infusion System, Dose IQ Safety Software
K
16
2613
Integrated Catch-up Freedom Syringe Driver Infusion System
K
16
1469
Plum 360(TM) Infusion System with MedNet/ Smart Card Plug and Play Module
K
16
1667
Sapphire Infusion Pump
K
14
3369
MRidium 3860+ MRI infusion Pump/ Monitoring System
K
15
3599
Concert Medical Hands-Free Syringe (HFS)
K
15
3193
Halo II Ambulatory Infusion System (also with trade names Nimbus II Ambulatory Infusion System, EVAA Ambulatory Infusion System)
K
15
1255
Navigator Aesthetic Delivery System
K
14
2596
Infusomat Space Volumetric Infusion Pump
K
14
1789
PLUM 360 INFUSION SYSTEM WITH HOSPIRA MEDNET, SMART CARD PLUG N PLAY CE 3.0 MODULE FOR PLUM A+ INFUSION SYSTEM UPGRADE
K
14
1389
SAPPHIRE INFUSION PUMP
K
14
0783
HALO AMBULATORY INFUSION SYSTEM
K
13
3532
ALARIS SYSTEM WITH GUARDRAILS SUITE MX
K
14
1654
THE BELMONT RAPID INFUSER
K
14
1102
HOSPIRA MEDNET MEDICATION MANAGEMENT SUITE
K
13
3801
BAXTER SIGMA SPECTRUM INFUSION PUMP WITH MASTER DRUG LIBRARY
K
12
3049
SAPPHIRE INFUSION PUMP
K
12
3822
KLEIN TOUCH PUMP AND DISPOSABLE TUBING SET
K
13
0690
Z-800 INFUSION SYSTEM
K
12
1613
AGILIA INFUSION SYSTEM
K
12
4053
NAVIGATOR DELIVERY SYSTEM (NAVIGATOR DS)
K
11
1275
CADD SOLIS VIP AMBULATORY INFUSION PUMP AND CADD SOLIS MEDICATION SAFETY SOFTWARE
K
12
2215
NAVIGATOR DELIVERY SYSTEM (NAVIGATOR DS)
K
12
0830
NAVIGATOR DELIVERY SYSTEM (NAVIGATOR DS)
K
11
0535
ALARIS PC UNIT MODULE 8000 WITH SOFTWARE CORRECTION
K
11
0901
SYMBIQ INFUSION AND ADMINSTRATION SET
K
11
2067
NAVIGATOR DELIVERY SYSTEM (NAVIGATOR DS)
K
11
1386
MEDFUSION MODEL 4000 SYRINGE INFUSION PUMP, PHARMGUARD TOOLBOX 2 MEDICATION SAFETY SOFTWARE AND SUPPORTED SYRINGES (PSS)
K
10
1194
NAVIGATOR DELIVERY SYSTEM (OR NAVIGATOR DS) MODEL: NAV-010
K
10
0705
ZYNO Z-800 INFUSION SYSTEM MODEL Z-800
K
10
0798
MEDRAD INTEGO PET INFUSION SYSTEM, SOURCE ADMINISTRATION SET, PATIENT ADMINSTRATIN SET MODEL INT SYS 100, INT CSS, INT C
K
10
0704
ACCU-CHEK FLEXLINK PLUS INFUSION SET, ACCU-CHECK LINKASSIST PLUS INSERTION DEVICE
K
09
3332
DELPHI INFUSION PUMP/ DELPHI ADMINISTRATION SET MODEL IV-01000/ MODEL IV-02XXXX (WHERE X IS ANY NUMBER BETWEEN 0-9)
K
09
1441
SYNERGETICS ADJUSTABLE GAS PRESSURIZED INFUSION (AGPI) TUBE SET
K
09
1386
MICROFUSE DUAL RATE INFUSER
K
09
1308
ALARIS PC UNIT, MODELS 8000 AND 8015
K
09
1855
THE BELMONT FLUID MANAGEMENT SYSTEM/ THE BELMONT RAPID INFUSER, MODEL FMS2000
K
08
3689
INFUSOMAT SPACE VOLUMETRIC INFUSION PUMP SYSTEM
K
09
0736
POWER INFUSER, MODEL M100B-3A
K
09
1042
CRONO S-PID 50
K
09
0087
MRIDIUM 3860 MRI INFUSION PUMP/MONITORING SYSTEM
K
08
1412
PLUM A+ HYPERBARIC INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE
K
07
2603
ABC SYRINGE INFUSION PUMP, MODEL 4100
K
08
3019
GEMSTAR SP INFUSION SYSTEM WITH GEMSTAR SP INFUSION SUITE SOFTWARE
K
08
2182
AP 34 MULTI-THERAPY INFUSION PUMP
K
08
0297
MEDRAD INTEGO PET INFUSION SYSTEM
K
07
3051
MEDRAD CONTINUUM MR INFUSION SYSTEM WITH WIRELESS REMOTE ACCESSORY
K
08
0954
T34L SYRINGE DRIVER
K
08
0743
LOCKBOX FOR USE WITH CADD SOLIS INFUSION PUMP
K
07
2105
ALARIS SYSTEM WITH MMS, MODEL 8XXX
K
07
1588
DISPENSER DP 20
K
07
1545
Z-800 VOLUMETRIC INFUSION PUMP
K
07
0235
BODYGUARD PAIN MANAGER INFUSION SYSTEM
K
07
0529
AFF (MARK I) VOLUMETRIC INFUSION PUMP
K
07
0398
HOSPIRA PLUM A+ INFUSION PUMP, MODEL 12391
K
07
0125
COLLEAGUE GUARDIAN CONFIGURATION TOOL; COLLEAGUE DL2 EVENT HISTORY DOWNLOAD SOFTWARE APPLICATION
K
07
0718
MODIFICATION TO: BODYGUARD INFUSION SYSTEM
K
06
3696
COLLEAGUE VOLUMETRIC INFUSION PUMP MODEL# 2M8151,8153,8161,8163,9161,9163
K
07
0268
SIGNATURE EDITION INFUSION SYSTEM, MODELS 710X, 720X
K
06
1108
STRYKER AUTO IRRIGATION SYSTEM
K
05
2973
IPUMP PAIN MANAGEMENT SYSTEM, MODEL 2L3107, 2L3107K
K
06
2592
CADD-SENTRY PRO MEDICATION SAFETY SOFTWARE
K
06
3288
SIGNATURE EDITION GOLD INFUSION SYSTEM, MODEL 7X3X
K
06
2700
INFUSOMAT SPACE VOLUMETRIC INFUSION PUMP SYSTEM
K
06
2699
PERFUSOR SPACE INFUSION SYRINGE PUMP SYSTEM
K
06
1325
BODYGAURD PAIN MANAGER INFUSION SYSTEM
K
05
3554
COMPUFLO
K
06
1128
MODIFICATION TO MEDRAD CONTINUUM MR INFUSION SYSTEM
K
06
0479
MODIFICATION TO BODYGUARD INFUSION PUMP SYSTEM
K
06
0806
HOSPIRA GEMSTAR INFUSION PUMP SYSTEM, 7 THERAPY, MODEL 13087; 6 THERAPY, MODEL 13086; PAIN MANAGEMENT, MODEL 13088
K
05
2817
EUREKA INFUSION PUMP, MODELS EUREKA-IP, EUREKA-LF
K
06
0119
MCKINLEY SATURATION CATHETER
K
05
2594
WILLCARE, MODEL GW-1020
K
05
3226
ZIMMER AMBULATORY PUMP PAIN MANAGEMENT SYSTEMS WITH FENESTRATED CATHETER AND FLOW SPLITTER
K
05
2221
AMBIT PUSH & PLAY AMBULATORY INFUSION PUMP
K
05
2218
CRONO FIVE AND CRONO PCA 50
K
05
0800
NIKI T34 AND BODYGUARD T34 SYRINGE DRIVERS
K
05
1568
CADD-MS 3 AMBULATORY INFUSION PUMP
K
05
1641
ALARIS SYSTEM PC UNIT, MODEL 8001
K
05
2171
ZIMMER AMBULATORY PUMP PAIN MANAGEMENT SYSTEM WITH PATIENT CONTROL MODULE
K
05
2217
CRONO SUPER PID
K
05
2219
CRONO GO.
K
05
2052
HOSPIRA PLUM A+ INFUSION PUMP SYSTEM V11.5, HOSPIRA PLUM A+ 3 INFUSION PUMP SYSTEM, V11.5
K
05
1045
SIMPLECHOICE 3.0 ML RESERVOIR PRO REFERENCE NUMBER RP-30
K
05
1252
MICROPUMP MP-101
K
04
3466
PAINPUMP2
K
05
0324
INFPUMP INFILTRATION PUMP
K
05
0474
VEINNOVATIONS INFILTRATION SYSTEM
K
05
0433
ZIMMER AMBULATORY PUMP PAIN MANAGEMENT SYSTEM
K
04
3204
SGARLATO LABS PAINFREE PUMP AND PAIN CONTROL INFUSION PUMP
K
04
3600
MEDTRONIC MICROMED 407C INFUSION PUMP, MODEL MMT-407C
K
04
3590
SE INFUSION SYSTEM WITH MMS
K
05
0301
MRIDIUM 3850 MRI PUMP SYSTEM
K
04
2696
BODYGUARD INFUSION PUMP SYSTEM
K
05
0107
HARVARD 2 SYRINGE PUMP, MODEL 2001-001
K
04
2432
PHARMGUARD TOOLBOX, MODEL G6000782
K
04
0985
PUMP CONNECTIVITY INTERFACE
K
04
2980
HOSPIRA GEMSTAR INFUSION PUMP SYSTEM, HOSPIRA GEMSTAR CONNECT SOFTWARE
K
04
2228
BEELINE MOTIV, PROPOLIS, PCA
K
04
2405
PAINPUMP1; PAINPUMP2
K
04
2609
HOSPIRA MEDNET MEDICATION MANAGEMENT SUITE
K
04
1714
E-PAIN CARE
K
04
2085
CRONO F
K
04
2121
SPECTRUM AND SPECTRUM WITH MASTER DRUG LIBRARY
K
04
2081
PLUM A+ INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE , AND PLUM A+3 INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE
K
04
1738
BAXTER INFUSOR SV (SMALL VOLUME); BAXTER INFUSOR LV (LARGE VOLUME)
K
04
1414
CRONO AND CRONO, MODEL 30
K
04
1241
MEDLEY SYSTEM WITH BAR CODE MODULE, MODEL 8600
K
04
1550
HOSPIRA PHOENIX INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE
K
04
1191
COLLEAGUE VOLUMETRIC INFUSION PUMPS
K
04
0149
PSI-TEC PERISTALTIC INFILTRATION PUMP
K
04
1152
THINSET 1.8 ML RESERVOIR, MODEL 326A; THINSET 3.0 ML RESERVOIR, MODEL 332A
K
04
0899
MEDEX 3000 SERIES MR SYRINGE INFUSION PUMP
K
04
0061
MEDTRONIC MINIMED MMT-407C AMBULATORY INFUSION PUMP, MODEL MMT-407C
K
04
0114
ABBOTT DATA PORT PC, MODEL 12181
K
03
0739
INFUSION DYNAMICS (ID) POWER INFUSER, MODEL M100B-3A WITH BLOOD CARTRIDGE
K
03
3425
AMBIT INTERMITTENT AMBULATORY INFUSION PUMP
K
03
3325
AMBIT CONTINUOUS AMBULATORY INFUSION PUMP
K
03
2789
REPLACEMENT PUMP HEAD DOOR ASSEMBLY, P1, MODEL BX10468, REPLACEMENT PUMP HEAD DOOR ASSEMBLY, P2, MODEL BX10469
K
03
2771
MEDRAD CONTINUUM MR INFUSION SYSTEM
K
03
2642
BEELINE SYSTEM
K
03
2005
MEDTRONIC MINIMED PARADIGM RESERVOIR, MODEL MMT-332
K
03
1749
BODYGUARD INFUSION SYSTEM
K
03
1600
CONDUCTION CATHETER
K
03
1432
KLEIN SURGICAL INFILTRATION PUMP, MODEL KIP-II
K
03
2147
SIGNATURE EDITION INFUSION PUMP, SIGNATURE EDITION ADMINISTRATION SETS, MODELS 70XX, 71XX, 72XX, 7XXXX SERIES
K
03
1249
MODIFICATION TO STRYKER PAINPUMP
K
03
0576
ANSPACH IRRIGATION PUMP AND IRRIGATION PUMP II
K
03
1185
ABBOTT PLUM A+ INFUSION PUMP WITH A HPL/RS PLUG-AND-PLAY MODULE
K
03
0885
MODIFICATION TO STRYKER PAINPUMP2
K
03
0459
MEDLEY SYSTEM WITH MEDICATION MANAGEMENT SYSTEM (MMS)
K
03
0323
MRI-CADDY
K
02
3189
VISTA BASIC WITH FM SYSTEM
K
02
4190
FENESTRATED INFUSION CATHETER
K
02
3083
SILBERG T.P.S., TISSUE PREPARATION SYSTEM, MODEL ME 800
K
02
3973
AUTOMED 3200 INFUSION PUMP
K
02
3863
AUTOMED 3000 INFUSION PUMP
K
02
4056
SURESET 3.0 ML RESERVOIR, MODEL 24-103
K
02
4084
ABBOTT PLUM A+ INFUSION PUMP, MODEL 12391
K
02
3264
MEDLEY SYRINGE PUMP MODULE SYSTEM, MODEL 8110
K
02
3827
PARAGON INFUSION SYSTEM WITH BOLUS
K
02
3491
AUTOMED 3300 AND 3400 INFUSION PUMP SYSTEM
K
02
3062
GEMSTAR INFUSION PUMP SYSTEM, 7 THERAPY, 6 THERAPY & PAIN MANAGEMENT
K
02
2869
SOAKER CATHETER
K
02
1988
MEDRAD CONTINUUM MR COMPATIBLE INFUSION SYSTEM
K
02
2575
PERFUSOR COMPACT WITH FM SYSTEM
K
02
1350
ABBOTT PLUM A+3 MULTICHANNEL INFUSION PUMP, MODEL 12348
K
01
3840
MICROJET CRONO PAR AND CRONO APO-GO
K
01
3855
MICROJET CRONO H
K
01
3776
MICROJET MODEL # CD4 AND CD4/20
K
01
3234
MICROJET CRONO
K
02
0947
MODIFICATION TO DYONICS INTELIJET REUSABLE CANNULAS
K
02
0881
MODIFICATION TO PERSONAL INFUSOR LOCAL PAIN MANAGEMENT PROCEDURAL KIT
K
02
0251
PARAGON INFUSION SYSTEM
K
01
4091
STRYKER PAINPUMP
K
01
3767
SIMPLICITY INFUSION RESERVOIR FOR USE TO INFUSE MEDICINE, INCLUDING INSULIN, FROM AN EXTERNAL INFUSION PUMP
K
01
2383
GEMINI PC-1,PC-2, PC-2TX,PC-4, SIGNATURE EDITION INFUSION PUMP (SE), MEDSYSTEM III INFUSION (MSIII), MEDSYSTEM PATIENT C
K
01
1975
HORIZON OUTLOOK WITH DOSECOM
K
01
2044
BI-PHASIC INFILTRATOR
K
00
3966
WUNDCATH CONDUCTION CATHETER
K
01
0937
SEP-10S PLUS, AND SP-12S PRO.
K
01
1442
ABBOTT PLUM A+INFUSION PUMP, MODEL 11971
K
00
3543
STRYKER PAINPUMP PCA
K
01
0566
COLLEAGUE VOLUMETRIC INFUSION PUMP
K
01
1096
ABBOTT ACCLAIM ENCORE, MODEL 12237
K
01
0924
MODIFICATION TO PLUM XL INFUSION PUMP
K
00
3611
PAIN CARE MULTI-PORT CATHETER, MODEL 2000L
K
00
3616
COLLEAGUE (3CX, 3, CX) VOLUMETRIC INFUSION PUMP
K
00
3582
FLUIDSENSE FLUID DELIVERY SYSTEM MODEL FS-01
K
00
3029
INFUSOMAT P
K
00
2679
6060 MULTI-THERAPY PUMP, MODEL 2M9832; 6060 EPIDURAL PUMP, MODEL 2L9351
K
00
2380
INFUSOR SV, INFUSOR LV, BAXTER PAIN MANAGEMENT SYSTEM
K
00
1829
MINIMED PARADIGM INSULIN PUMP, MODEL 511
K
00
1828
PARADIGM 1.5ML RESERVOIR, MODEL 326
K
99
3524
ADVANTIS ASC INFUSION PUMP AND ADMINISTRATION SETS
K
00
2211
COLLEAGUE CX VOLUMETRIC INFUSION PUMP 2M8161 AND VOLUMETERIC INFUSION PUMP 2M8151
K
00
2126
ABBOTT ACCLAIM ENCORE STANDARD TUBING PUMP
K
00
1629
DISETRONIC MULTIFUSE INFUSION PUMP SYSTEM
K
00
0842
CADD-PRIZM PCS II MODEL 6101 AMBULATORY INFUSION SYSTEM
K
99
4274
QUEST MPS PERFUSION ASSISTED DIRECT CORONARY ARTERY BYPASS (PADCAB)
K
00
0328
MEDEX 3000 SERIES MRI COMPATIBLE SYRINGE INFUSION PUMP
K
00
0821
ABBOTT GEMSTAR I.V. INFUSION PUMP - 7 THERAPY CONFIGURATION, 6 THERAPY CONFIGURATION, 1 THERAPY CONFIGURATION
K
99
4375
HORIZON LIGHT
K
99
4374
SOAKER CATHETER
K
99
4275
SIMS PORTEX ANESTHESIA CATHETER
K
99
1936
3.0 ML RESERVOIR, MODEL 103/193
K
99
4039
ABBOTT GEMSTAR I.V. INFUSION PUMP-7 THERAPY CONFIGURATION, ABBOTT GEMSTAR I.V. INFUSION PUMP-6 THERAPY CONFIGURATION, AB
K
99
3387
IPUMP PAIN MANAGEMENT SYSTEM, MODEL 2L3107K
K
99
1203
IRRIGATION OR INFUSION PUMP K PUMP
K
99
2044
INFUSION DYNAMICS POWER INFUSER MODEL M100B
K
99
1437
WELLS JOHNSON INFUSION SYSTEM, MODEL 20-6000-00
K
99
2672
BELMONT FLUID MANAGEMENT SYSTEM (FMS2000)
K
99
1275
WALKMED 300, WALKMED 350, WALKMED IC, WALKMED PCA, WALKMED PLUS
K
99
1013
MINIMED 407C INFUSION PUMP, MODEL 407C
K
99
1501
ACCLAIM INFUSION PUMP
K
99
1363
30 PUMP, CONTINUOUS LOW FLOW, 200 PUMP, INTERMITTENT WITH KVO OR CONTINUOUS, PCA PUMP, PAIN MANAGEMENT, PCEA PUMP, EPIDU
K
99
0447
1000 PRESSURE INFUSION SIGMACON 1000
K
99
0425
SIDEKICK INFUSION KIT
K
98
2640
MEDEX 3000 SERIES SYRINGE INFUSION PUMP
K
99
0518
PEREGRINE WET SET, MODEL PD400.00
K
99
0101
PAIN CONTROL INFUSION PUMP
K
98
0751
SABRATEK 4040 INFUSION PUMP
K
99
0259
DISETRONIC MULTIFUSE INFUSION PUMP SYSTEM
K
98
3005
PERFUSOR COMPACT
K
98
2159
ABBOTT PLUM A+ INFUSION PUMP
K
97
4332
VARIABLE PRESSURE SYRINGE PUMP
K
98
0378
MELODIE INFUSION PUMP
K
98
1816
CUE AMBULATORY VOLUMETRIC INFUSION PUMP
K
98
3975
BELMONT FLUID MANAGEMENT SYSTEM (FMS2000)
K
98
2170
FLUIDSENSE FLUID DELIVERY SYSTEM
K
98
3838
ABBOTT LIFECARE STANDARD TUBING INFUSION PUMP
K
98
2838
CADD-LEGACY 1 AMBULATORY INFUSION SYSTEM MODEL NUMBER 6400
K
98
2836
CADD-LEGACY PLUS AMBULATORY INFUSION SYSTEM
K
98
3321
MICROFUSE DUAL RATE INFUSER
K
98
2020
METRON QA-IDS I.V. PUMP TESTER
K
97
3593
BRIDGE SENTRY BEDSIDE UNIT, BRIDGE SENTRY ADMINISTRATION SET-STANDARD CONFIGURATION, BRIDGE SENTRY ADMINISTRATION SET 5
K
98
1776
ALEXANDER MANUFACTURING CO. BATTERY PART NUMBER MC146X
K
98
0738
PSI-TEC SYRINGE INFUSION PUMP AND ACCESSORIES FOR GENERAL FLUID IRRIGAION/INFILTRATION
K
98
0089
3600 PRESURE INFUSOR, SIGMACON 3600, LAPRO FLOW 3000
K
97
4778
ABBOTT GEMSTAR IV INFUSION PUMP
K
98
0092
SMITH & NEPHEW DYONICS INTELIJET REUSABLE CANNULAS
K
97
3917
CADD-DIPLOMAT PC COMMUNICATIONS SYSTEM AND THE CADD- AMBASSADOR PUMP COMMUNICATIONS SYSTEM
K
97
3851
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY #M12/630
K
97
3609
IDA-4 AND IPT-MC
K
97
2284
FLUID MANAGEMENT SYSTEM
K
97
2678
MILLENNIUM CRT INFUSION PUMP AND MILLENNIUM CRT INFUSION PUMP ADMINISTRATION SETS
K
97
3133
BIG BAG 3000 PRESSURE INFUSOR
K
96
3574
PULSE*SPRAY INJECTOR
K
96
5230
ABBOTT LIFECARE STANDARD TUBING INFUSION PUMP
K
96
1862
MODELS IDA-2 PLUS AND IPT-1
K
96
1975
DISETRONIC D-MODEM
K
96
0512
GEMINI PC-ITX
K
96
2709
SIGMA SYRINGE DELIVERY SYSTEM(MULTI-DOSER REV. 1/MULTI-DOSER REV. II/SINGLE-DOSER REV. 1-10/SINGLE-DOSER REV. 1-20/
K
96
1263
MODEL 1200 ABMULATORY INFUSION PUMP
K
96
0826
CADD-PRIZM MODEL 6100 PUMP
K
95
5231
MEDFUSION MODEL 2001 SYRINGE INFUSION PUMP
K
96
1703
COLLEAGUE 2 VOLUMETRIC INFUSION PUMP(DUAL CHANNEL)/COLLEAGUE 3 VOLUMETRIC INFUSION PUMP(TREE CHANNEL)
K
96
0957
EXTERNAL POWER SOURCE (EPS) SYSTEM, POWER PACK
K
95
5258
3030 INFUSION PUMP
K
95
4826
DISETRONIC MULTIFUSE PUMP SYSTEM
K
95
5180
CADD-PCA, -MICRO, -PRIZM AMBULATORY INFUSION PUMP
K
95
3896
THE IMED AMBULATORY INFUSION PUMP, ADMINISTRATION SETS
K
95
2967
UNIMED MEDICAL DISPENSING PUMP
K
95
2799
ABBOTT XL3M INFUSION PUMP
K
95
3098
VOLUMETRIC INFUSION PUMP
K
95
3731
PANCRETEC PROVIDER APM INFUSION PUMP (MODIFICATION)
K
94
4352
SMARTDOSE III INFUSION CONTAINER
K
94
4351
SMARTDOSE IV PREFILLED INFUSION CONTAINER
K
95
3660
PLUM XL INFUSION PUMP (MODIFICATION)
K
95
3382
ACCUPUMP 901 (MODEL NUMBERS 50 & 100)
K
95
3270
MODEL 1100 MEDMATE INFUSION PUMP
K
94
3952
DISETRONIC D-MODEM
K
93
3825
ADI SYSTEM
K
95
2794
HARVARD 2 SYRINGE PUMP
K
94
4721
9000 INFUSION PUMP
K
94
4669
FLEXIFLO QUANTUM ENTERAL PUMP
K
94
5942
AUTO SYRINGE(R) AS50 INFUSION PUMP
K
95
0419
THE IMED ORION INFUSION PUMP AND ADMINISTRATION SETS
K
94
4750
CORFLO 300 PUMP
K
94
4190
LIFECARE 175 INFUSER, MODIFICATION
K
94
3692
SMART DOSE(TM)
K
95
0766
SIGMA 8000 AND SIGMA 8002
K
94
2378
POCKET PUMP
K
94
4733
PLUM XL INFUSION PUMP
K
94
1595
MICROJECT MODEL 200, MODEL 30, AND MODEL TPN-5
K
93
1318
3400 INFUSION PUMP
K
94
4125
ABBOTT LTE INFUSION PUMP
K
94
2162
SIGMA 8000 AND SIGMA 8002
K
93
3545
SIEMENS FLUID DELIVERY SYSTEM, MMT-9500
K
94
0446
3M MODEL 3000 & MODEL 3100 INFUSION PUMP (MODIFICATION)
K
94
2161
LOCKBOX
K
94
1984
SABRATEK 6060 HOMERUN VOLUMETRIC INFUSION PUMP
K
92
2702
PROVIDER ANNE INFUSER
K
94
1151
STRATOFUSE PCA II INFUSER
K
93
2847
CORPAK ENTERAL PUMP
K
93
3652
FREEDOM 60 SYRINGE INFUSION PUMP SYSTEM WITH SYRINGE SET & TUBING
K
93
0494
PANOJECT MINIFUSOR MODEL 100 AMBULATORY INFUSION
K
93
0495
PANOJECT MINIFUSOR MODEL 200 AMBU. INFUSION PUMP
K
92
6385
BARD APII PUMP
K
94
0147
AUTO SYRINGE AS40A INFUSION PUMP
K
93
2895
RIVER PUMP
K
93
1458
MEDIPAK AMBULATORY INFUSION PUMP
K
92
4603
PHARMETRIX MINIPUMP MODEL 5120
K
92
4527
VIVUS 5000 INFUSION SYSTEM
K
93
4671
HI-FLO INFUSION PUMP
K
91
5649
BARD 500ML RESERVOIR HOLDER
K
93
3506
SYRINGE INFUSER
K
92
3224
KVOI.V. FLUSH SYSTEM
K
91
0007
SPRINGFUSOR 10R
K
92
3290
COMPUTER - COMPUTERS AND SOFTWARE, MEDICAL USE
K
93
3005
AVI MODEL 600 SYRINGE PUMP
K
93
3006
AVI INFUSION PUMPS, ADDITIONAL INTENDED USE
K
93
3144
GEMINI VOLUMETRIC INFUSION PUMP/CONTROLLER
K
93
2544
IVAC SPACE SAVER VOLUMETRIC PUMP, MODEL 599
K
93
1549
MODEL EZ-1 SING CHAN/EZ-2 DUAL CHANNEL INFUS PUMP
K
92
2670
THE MINIMED MODEL 404-SP AND 504-S
K
92
1901
PORT ACCESS INFUSION SET
K
93
1375
ABBOTT PLUM XL INFUSION PUMP
K
92
6191
SIGMA 7000 AND SIGMA70002
K
93
1132
CADD-MICRO(TM) MODEL 5900 AMBULATORY INFUSION PUMP
K
93
0781
INFUSION PUMP
K
92
5311
TRILOGY INFUSION PUMP
K
93
0459
BARD MINI-INFUSER 1500 & 3000
K
92
1050
ULTRAFLO RATESAVER PLUS INFUSION PUMP
K
92
5091
IVAC SYRING PUMP MODEL 770
K
92
5196
BARD EPIDURAL PUMP
K
92
5112
BIO CLINIC UNDER PATIENT SCALE
K
92
4871
MODEL 880 INFUSION PUMP, MODIFICATION
K
92
4865
MODEL 285 INFUSION PUMP, MODIFICATION
K
92
4872
MODEL 885 INFUSION PUMP, MODIFICATION
K
92
4870
MODEL 480CI INFUSION PUMP, MODIFICATION
K
92
4869
MODEL 480CM INFUSION PUMP, MODIFICATION
K
92
4868
MODEL 480 INFUSION PUMP, MODIFICATION
K
92
4867
285CI INFUSION PUMP, MODIFICATION
K
92
4866
MODEL 285CM INFUSION PUMP, MODIFICATION
K
92
3875
SIDEKICK 50 PLUS AND SIDEKICK 100 PLUS
K
92
5449
REPLACEMENT RECHARGEABLE BATTERY PACK'S
K
92
3068
AVI MODEL 3100 INFUSION PUMP
K
92
3829
LIFECARE 175 INFUSER -- MODIFICATION
K
92
2074
DCR VOLUMETRIC INFUSION PUMP W/ NEW MAINS POWER PK
K
92
3981
IVAC SYRINGE PUMP - 740 SERIES
K
92
3601
PANCRETEC PROVIDER INFUSION PUMP -- MODIFICAITON
K
92
2909
MEDICAL BATTERY PACKS
K
91
4122
VITAL INFUSION PUMP
K
91
5407
PHARMETRIX MEDIPUMP MODEL 524
K
91
5566
DISETRONIC PANOMAT PUMP
K
91
5646
VIVUS 50 AND VIVUS 100 PERSONAL INFUSER
K
92
1378
IMED MODEL PC-4 VOLUMETRIC INFUSION PUMP/CONTROLLE
K
92
1073
AVI MODEL 480CI INFUSION PUMP
K
92
1072
AVI MODEL 470CI INFUSION PUMP
K
91
4589
SABRATEK 3030 INFUSION PUMP
K
92
0013
UNI-DOSE SYRINGE PUMP
K
92
0773
DURAFUSE INFUSION PUMP
K
92
0680
AVI MODEL 275CI INFUSION PUMP
K
92
0681
AVI MODEL 285CI INFUSION PUMP
K
92
0588
AVI MODEL 3000 INFUSION PUMP
K
91
4988
500 INFUSER
K
91
3891
DISETRONIC(R) INFUSOR
K
91
5499
FLO-GARD 8000 HALF-SET
K
91
3931
PANCRETEC PROVIDER(R) MODEL 5500 INFUS PUMP, MODIF
K
91
5523
FLO-GARD(R) 6301
K
91
5522
FLO-GARD(R) 6201
K
91
2193
3000 INFUSION PUMP
K
91
2192
3100 INFUSION PUMP
K
91
4855
MULTIPLE DOSE CONTROLLER
K
91
4854
THUMPER
K
91
5231
EPIDURAL INDICATION FOR VOLUMETRIC INFUSION PUMPS
K
91
4349
PROVIDER APM INFUSION PUMP
K
91
3661
MODIFIED VOLUMETRIC INFUSION PUMP
K
91
3907
VIVUS PS (PROGRAMMING SOFTWARE)
K
91
1782
PUMPMAN(TM) AMBULATORY DRUG DELIVERY SYSTEM
K
91
1103
DANBY D.S.P. SYRINGE PUMP
K
90
4619
INFU.DISK
K
91
4034
INFUCARE SYRINGE PUMP TUBING SET
K
91
3718
PANCRETEC I.V. MODEL 5000 INFUS DEVICE, MODIFIED
K
91
3719
PANCRETEC I.V. MODEL 5500 INFUSER
K
91
3720
PANCRETEC PROVIDER ONE INFUSION SYSTEM, MODIFIED
K
91
3895
FLO-GARD(R) 6200, 6300 & 8000
K
91
2589
AVI MODEL 840D DUAL CHANNEL INFUSION PUMP
K
91
2590
AVI MODEL 400D INFUSION PUMP
K
90
4924
INFUSA PU SYRINGE INFUSION PUMP
K
91
3056
VOLUMETRIC INFUSION PUMP, MODIFICATION
K
91
2591
AVI MICRO 210D INFUSION PUMP
K
90
4923
INFUSA T SYRINGE INFUSION PUMP
K
90
4922
INFUSA D.SLT SYRINGE INFUSION PUMP
K
90
4925
INFUSA TS SYRINGE INFUSION PUMP
K
91
2928
LIFECARE 4100 PCA INFUSER PLUS II
K
91
2914
DANBY-DCR VOLUMETRIC INFUSION PUMP
K
91
2875
AVI MODEL 270CI INFUSION PUMP
K
91
2738
AVI VOLUMETRIC INFUSION PUMPS-VARIOUS MODELS
K
91
2092
MODIFIED LIFECARE MODEL 175 INFUSER
K
91
1964
MODIFIED PANCRETEC PROVIDER ONE INFUSION SYSTEM
K
90
5713
BARD AMBULATORY PUMP TUBING SET
K
90
5778
EPIDURAL INDICATION FOR BAXTER INFUSORS ATTACHMENT
K
91
2458
MODEL 404-SP AND 504-SP INFUSION PUMPS MODIFIED
K
91
0934
FLO-GARD 6300 DUAL CHANNEL VOLUMETRIC INFUSION PUM
K
90
4890
BARD ALFENTANIL INFUSER
K
91
2031
AVI MODEL 870 DUAL CHANNEL INFUSION PUMP
K
91
1769
RATEMINDER(TM) V INFUSION PUMP, MODIFICATION
K
91
0844
INFUSION PUMP
K
91
0024
VOLUMETRIC INFUSION PUMP
K
91
0350
MICREL LTD-PORTABLE INFUSION PUMP-MP20Q
K
91
0758
MICREL LTD - PORTABLE INFUSION MICROPUMP-MP11
K
91
1401
ABBOTT LIFECARE 5000 PUMP
K
91
0919
ABBOTT LIFECARE 5000 PUMP MODIFIED
K
91
1289
EPIDURAL INDICATION FOR BAXTER SYRINGE INFUS PUMP
K
91
0637
MENTOR(R) SUR-E-TROL(R)
K
90
2613
BARD PCA II PUMP WITH PROGRAM CARTRIDGES
K
91
0428
EPIDURAL INDICATION FOR VOLUMETRIC INFUSION PUMPS
K
91
0425
LARGE VOLUME ELASTOMERIC INFUSION DEVICE ATTACH.
K
91
0523
MODIFIED VOLUMETRIC INFUSION PUMPS ATTACHMENTS
K
91
0335
MTP TRANSPORT INFUSION PUMP, MODEL NO. MTPLEA
K
90
5696
STRATOFUSE PCA INFUSER
K
90
5610
MICRORATE INTELLIGENT PUMP
K
90
5611
MICRORATE PLUS INTELLIGENT PUMP
K
90
5251
MTP TRANSPORT INFUSION PUMP MODEL NO. 1001A
K
90
3571
MICREL LTD PORTABLE INFUSION MICROPUMP
K
90
4979
AVI MODEL 600 SYRINGE PUMP, MODIFICATION
K
90
5783
MODIFIED WALKMED 400
K
90
4403
BARD AMBULATORY PCA DRUG DELIVERY SYSTEM
K
90
5029
MODEL 2001, MODIFICATION
K
90
3343
SYRINGE INFUSION PUMP
K
90
2891
VERIFUSE AMBULATORY PUMP
K
90
0217
BARD MICROBORE ANTI-SIPHON NITRO SET
K
90
4518
VOLUMETRIC INFUSION PUMP
K
90
1550
IVAC(R) SYRINGE PUMP - MODEL 770
K
90
3879
IVAC(R) SYRINGE PUMP - MODEL 740
K
90
4048
MULTI DRUG INFUSION SYSTEM
K
90
1978
MULTI-DRUG INFUSION SYSTEM
K
89
7086
PARKER AMBULATORY MEDICATION INFUSION PUMP 2004
K
90
2432
AMBULATORY INFUSER AND ASSOC. FLOW CONTROLLING SET
K
90
2374
CADD-TPN MODEL 5700 AMBULATORY INFUSION SYSTEM
K
90
3782
AVI MODEL 270CM INFUSION PUMP
K
90
3783
AVI MICRO 275CM INFUSION PUMP
K
90
3785
AVI MODEL 400CM INFUSION PUMP
K
90
3786
AVI MICRO 845 DUAL CHANNEL INFUSION PUMP
K
90
3787
AVI MODEL 470CM INFUSION PUMP
K
90
3788
AVI MICRO 285CM INFUSION PUMP
K
90
3781
AVI MODEL 880 DUAL CHANNEL INFUSION PUMP
K
90
3789
AVI MICRO 885 DUAL CHANNEL INFUSION PUMP
K
90
3784
AVI MODEL 480CM INFUSION PUMP
K
90
1755
MODEL 3001 SYRINGE INFUSION PUMP
K
90
0467
LIFECARE MODEL 4 PUMP
K
90
0468
LIFECARE(R) MODEL 3 PUMP
K
90
1065
INFUSION PUMP
K
89
6075
CADD-PCA AMBULATORY INFUSION PUMPS
K
90
2309
PARKER MICROPUMP MODEL 2100
K
90
2835
FTS-100 FLUID TRANSFER SYSTEM
K
89
5644
CADD-PCA AMBULATORY INFUSION PUMPS
K
89
4506
ENTERA-FLO ENTERAL FEEDING PUMP
K
90
0375
BECTON DICKINSON PROGRAM 2 INFUSION PUMP
K
89
6717
PARTNER INFUSION SYSTEM:
K
90
2092
RATEMINDER V INFUSION PUMP W/SECONDARY CAPABILITY
K
90
2409
BECTON DICKINSON 360 INFUSER (TM) SYSTEM
K
89
5710
ABBOTT LIFECARE 4100 PCA INFUSER
K
89
5709
ABBOTT PATIENT CONTROLLED ANALGESIA (PCA) PUMP
K
90
0742
RATE INFUSER PLUS
K
89
0736
TFV-2300 INFUSION PUMP
K
89
5867
PANCRETEC I.V. MODEL 5000 INFUSER
K
89
3769
LIFECARE MICRO PUMP (INFUSION PUMP)
K
89
5436
MODIFIED MINIMED III INFUSION PUMP
K
90
0888
LOCKBOX
K
89
6422
BURRON AMBULATORY DRUG DELIVERY SYSTEM
K
89
6544
MD2 PERSONAL INFUSION SYSTEM
K
90
0699
FLO-GARD 6300 BLOOD PUMPING INDICATION
K
90
0204
AVI MODEL 840 DUAL CHANNEL INFUSION PUMP
K
90
0057
LIFECARE(R) 175 INFUSER
K
89
7096
MODEL 404A I.V. INFUSION PUMP ANALYZER
K
89
7013
AVI MICRO 210CM INFUSION PUMP
K
89
6546
HOMEPUMP (DISP. ELASTOMERIC INFUSION DEVICE)
K
89
1289
FLO-GARD 6300 DUAL CHANNEL VOLUME INFUSION PUMP
K
89
6023
OHMEDA 9000 SYRINGE PUMP
K
89
5797
IMED 4100 AND 4200 DISPOSABLE INFUSION DEVICE
K
89
6593
BECTON DICKINSON RATE INFUSER II SYSTEM
K
89
5426
AMBULATORY INFUSION PUMP
K
89
4028
AMBULATORY INFUSION SYSTEM AND ACCESSORIES
K
89
1237
MODEL 600 SYRINGE PUMP
K
89
4292
BARD LIBERATOR DISPOSABLE INFUSION SYSTEM
K
89
3488
PULSATILE PUMP FOR GONADORELIN ACETATE
K
89
4321
MODEL 285 INFUSION PUMP
K
89
4320
MODEL 480 INFUSION PUMP
K
89
4360
MODEL 280 INFUSION PUMP
K
89
4041
PUMP-JECT SYRINGE WITH LUER-LOCK
K
89
4037
IVAC(R) SPACE.SAVER(TM) VOLUMETRIC PUMP MODEL 599
K
89
2210
MULTI-DRUG(TM) INFUSION SYSTEM
K
88
3645
LIFECARE MICRO PUMP
K
89
0862
AMBULATORY INFUSION PUMP
K
89
0786
IVSK09 CALIBRATION KIT AN ACCESSORY TO IV7000/7200
K
89
0120
SYRINGE INFUSION PUMP
K
89
2906
60 MICROBORE EXTENSION SET W/ANTI-SIPHON VALVE
K
88
4505
BASAL/BOLUS INFUSORS
K
89
1583
IVAC VARIABLE PRESSURE VOLUMETRIC PUMP, 570 SERIES
K
89
0783
GRIESHABER VISCOELASTIC INJECTION SYSTEM
K
89
0282
RESUBMITTED ABBOTT LIFECARE MODEL 3 HB PUMP
K
88
3609
ACCES. PACKAGE FOR USE W/CARDIOGEN-82 GENERATOR
K
89
0062
CADD-PCA MODEL 5800 AMBULATORY INFUSION PUMP
K
89
0457
MODIFIED MINIMED MDL404-SP/504-S DRUG INSULIN PUMP
K
88
3796
LIFECARE MICRO PUMP
K
88
2249
M.I.P. - PUMP
K
88
1759
BT-1 INFUSION PUMP
K
88
5083
INFUSA-PLATE(TM) EX
K
88
3993
MODIFIED IMED GEMINI PC-1 INFUSION PUMP
K
88
4014
FLO-GARD VP
K
88
3577
BARD INFUSOR PUMP
K
88
3587
BIOSEARCH 3600 ENTRI FEEDING PUMP
K
88
3653
EP-100 INFUSION PUMP
K
88
2598
250 ML BAG W/Y INJECT. & 12 EXTENSION SET
K
88
3902
INFUSA-PLATE
K
88
1079
UVP VOLUMED 2001
K
88
3003
MULTI-DRUG INFUSION SYSTEM
K
88
2594
THE OMNI-FLOW THERAPIST INFUSION MANAGEMENT SYSTEM
K
88
2556
BECTON DICKINSON PCA INFUSER - SOFTWARE MODIFI.
K
88
0857
SYRINGE PUMP MS2000
K
88
2159
522 INTELLIGENT PUMP
K
88
2102
PROVIDER ONE INFUSION SYSTEM
K
88
2107
PERFUSOR SECURA SYRINGE PUMP
K
88
2106
PERFUSOR M SYRINGE PUMP
K
88
2047
ENTRUST(TM) MODEL 800
K
88
0733
BARD PCA II INFUSION PUMP
K
88
1590
ADFUSE(TM)
K
87
5332
IVAC VOLUMETRIC PUMP - MODEL 590
K
87
5316
BIONICA MDS 110 PCA
K
87
4546
SIM MODULE
K
87
5365
MODEL 200A INFUSION PUMP
K
87
5348
MODEL 400A INFUSION PUMP
K
87
5347
MODEL 210A INFUSION PUMP
K
88
0479
IMED(R) GEMINI(TM) PC-1 VOLUMETRIC INFUSION PUMP
K
88
0204
CADD-TPA(TM) MODEL 5600 AMBULATORY INFUSION PUMP
K
88
0623
MINIMED MODEL 404-SP EXTERNAL INFUSION PUMP
K
88
0569
TEAMMATE(TM)
K
88
0625
HALF HOUR INFUSOR
K
87
5364
MODIFIED PCA INFUSER
K
87
5174
RATEMINDER V INFUSION PUMP
K
87
4181
BAXTER BEDSIDE SYSTEM
K
87
4564
MINIMED III INFUSION PUMP & UNI-SET ADMIN SET
K
87
4649
CADD-PLUS(TM) MODEL 5400 AMBULATORY INFUSION PUMP
K
87
3884
IVAC MODEL 560+ SERIES VOLUMETRIC INFUSION PUMP
K
87
3746
AUTO SYRINGE MODEL AS20G INFUSION PUMP
K
87
1881
MODEL 3000 INFUSION PUMP
K
87
2774
BETATRON IV SYSTEM
K
87
3494
RESERVOIR BAG
K
87
3495
PUMP TUBING SET
K
87
3961
INFUMED 300 AMBULATORY INFUSION PUMP
K
87
3522
BARD AMBULATORY PCA DRUG DELIVERY SYSTEM
K
87
2516
INFUSION PUMP MODEL 275
K
87
2514
INFUSION PUMP MODEL 270
K
87
2515
INFUSION PUMP MODEL 470
K
87
1807
BARD MICROINFUSER I INSULIN INFUSION PUMP
K
87
3938
IVAC(R) DUAL RATE SET - MODEL C50066
K
87
3847
CORMED III AMBULATORY INFUSION PUMP
K
87
3776
IVAC(R) STAR-FLOW(TM) VOLUMETRIC PUMP - MODEL 580+
K
87
3875
BAXA EXACTA-MED PHARMACY PUMP
K
87
3161
VALLEYLAB MODEL IV7200 INFUSION PUMP
K
87
2764
IVAC NITROGLYCERIN & LIPID ADMIN. SET MODEL S75053
K
87
3444
ENTECH ENTERAL PUMP AND SET
K
87
1806
PROVIDER IV. MODEL 5000 INFUSION DEVICE
K
87
2952
ULTRASONIC AIR-IN-LINE DETECTOR (AILD)
K
87
2741
NUTRIPUMP
K
87
0656
IMED(R) 980C VOLUMETRIC INFUSION PUMP
K
87
0801
FLO-GARD 6200 VOLUMETRIC INFUSION/PUMPING BLOOD
K
87
2850
RATE INFUSER SYSTEM
K
87
2821
INFUSION PUMP ENCLOSURE
K
87
1728
MODIFIED LIFECARE(R) 4100 PCA INFUSER
K
87
1084
NITROGLYCERINE PUMP SET
K
87
0330
SP55 SYRINGE PUMP
K
87
0991
IMED(R) MODEL 960A VOLUMETRIC INFUSION PUMP
K
87
0992
IMED(R) MODEL 965A VOLUMETRIC INFUSION PUMP
K
87
0524
AMBULATORY INFUSION PUMP DRUG RESERVOIR
K
87
0444
HOMEPRO II VOLUMETRIC INFUSION PUMP
K
87
0279
VP2000 INFUSION PUMP
K
86
4276
PERSONAL INFUSION PUMP
K
87
0768
AC ADAPTER ACCESSORY, PRODUCT CODE 600123A
K
87
0242
INTERMATE(TM)
K
86
4997
MEDTRAC VP VOLUMETRIC INFUSION PUMP
K
86
5051
GRASEBY PCAS MODEL NO. 0124-0701, PVS DYTINHR PUMP
K
86
4809
IVAC(R) STAR-FLOW(TM) VOLUMETRIC PUMP - MODEL 580
K
86
5060
I.V. SET WITH DUAL-CHANNEL CASSETTE
K
86
5059
I.V. SET W/SINGLE-CHANNEL CASSETTE
K
86
5058
ABBOTT LIFECARE (R) 5000, PUMP SYSTEM
K
86
3864
AMBULATORY INFUSION PUMP, MODEL AS30C
K
86
4808
STRATO(R) PCA INFUSER
K
86
4227
PERCUPUMP (TM)
K
86
3532
MODIFIED LABELING TO MODEL 2000 AMBULATORY INFUSER
K
86
4233
BARD HARVARD MINI-INFUSER 950 PUMP
K
86
3470
DALTEX IV INFUSION PUMP
K
86
4138
MINIMED MODEL 404-S EXTERNAL INFUSION PUMP
K
86
4517
MODEL 504-S EXTERNAL INFUSION PUMP FOR DIABETICS
K
86
3997
ABBOTT LIFECARE(R) 4100 PCA INFUSER
K
86
4106
SR-MODEL 230 (MODIFICATION)
K
86
3683
BARD HARVARD(TM) PCA JR INTERMITTENT INFUSION PUMP
K
86
2295
MODEL PC-2 VOLUMETRIC INFUSION PUMP/CONTROLLER
K
86
0353
SYRINGE INFUSION PUMP
K
86
2927
CADD-1, MODEL 5100 HF
K
86
1539
NIKKISO INFUSION PUMP MODEL PFA-02
K
86
1598
INTELLIGRAPH(TM) PROGRAMMER
K
86
1207
INTELLIJECT INFUSION PUMP
K
86
1208
INTELLIJECT MEDICATION SYRINGE
K
86
1209
STREAM-SWITCH MANIFOLD
K
86
1040
ENTERNAL INFUSER MULTIPUMP 203
K
86
1001
PARENTERAL INFUSER MEDIPUMP 204
K
86
1436
SOF SET, MODELS 111 AND 112
K
86
1324
PATIENTCARE 1000
K
86
0222
70 ML RESERVOIR BAG AND ADMINISTRATION SETS
K
86
0857
SOF SET, MODELS 113 AND 114
K
86
1007
BECTON DICKINSON PCAINFUSER
K
86
0969
FLUID MANAGEMENT SYSTEM (MODIFIED)
K
86
0694
IV7200 AND IV7400 INFUSION PUMP
K
86
0162
FLO-GARD 6200 VOLUMETRIC INFUSION PUMP
K
86
0229
MODEL 900 INFUSION PUMP
K
86
0218
SYRINGE PUMP: VM 07
K
86
0086
ENTERAL NUTRITION PUMPS PN 1000 AND VM 05
K
85
4318
LIFEPORT AMBULATORY INFUSION PUMP
K
85
3664
HEPARIN MICRO-INFUSOR
K
85
2168
ELECTRONIC COMMUNICATION SYS ACCESSORY FOR GRAVITY
K
85
4964
CADD-LD 5500 AMBU INFUSION PUMP&3010 10ML MED RES.
K
86
0502
G.A.S./GRIESHABER AIR SYSTEM
K
85
5215
AIR/FLUID EXCHANGE SYSTEM
K
86
0492
NORDISK INFUSER SYSTEM WITH PRE-FILLED CARTRIDGE
K
85
4157
PMT ACCUPRESSURE INFUSION SYSTEM 3601
K
85
3629
BARD HARVARD CHRONOFUSOR TIME-DOSE SYRINGE INFUSIO
K
85
3814
MP0400 ADULT, PERISTALIC INFUSION PUMP
K
85
4074
MODEL 200 INFUSION PUMP
K
85
4073
MODEL 210 INFUSION PUMP
K
85
2645
FLUID MANAGEMENT SYSTEM
K
85
3881
THE TRAVENOL 5 ML/HR INFUSOR
K
85
3393
INSULIN PUMP INSUMAT 229
K
85
0792
ODAC-ON DEMAND ARALGESIA BY COMPUTER-INFUSION PUMP
K
85
3584
CADD-1, MODEL 5100 HF, AMBULATORY INFUSION PUMP
K
85
3134
NATIONAL MED CARE INFUSION PUMP ADM SET #95-0001-8
K
84
2905
TRAVENOL MULTIDAY INFUSOR 2C1080
K
85
2965
ENTERAL FEEDING PUMP
K
85
2358
SYRINGE INFUSION PUMP - AS 20 SERIES
K
85
1821
VI-FLOW PUMP WITH VI-SET
K
85
2073
VIAL SYRINGE PUMPS, SE200, SE200B & SE400
K
85
2060
INFUSION SETS MODELS 9120,9121,9125, 9122 & 9123
K
85
1564
MODEL 2000 INDULIN INFUSION PUMP
K
85
1351
ENTERAL FEEDING PUMP
K
85
0997
UVP 2000 VOLUMED -TENTATIVE
K
85
1360
IMED GRAVISET INTRAVASCULAR ADMIN. SET
K
85
1447
IVAC MODEL 580 GENER. USE VOLUMETRIC INFUSION PUMP
K
85
1017
QUEST 521 VARIABLE PRESSURE VOLUMETRIC INFUSION PU
K
85
0729
ACUFLO VOLUMETRIC CONTROLLED DELIVERY SYS 2000
K
85
0674
CORMED II AMBULATORY INFUSION PUMP
K
85
0669
PROMINJECT PROGRAMMABLE INFUSION PUMP
K
85
0653
IMED 440 INFUSION PUMP & ADMINISTRATION SET
K
85
0488
STRATOFUSE SYRINGE PIGGYBACK PUMP 1030
K
85
0183
CADD-VT, 5300 AMBULATORY INFUSION PUMP W/3050, 50M
K
84
3311
IV ADMIN. SET FOR MVP 1 INFUSION PUMP
K
84
4401
REPRO-MED SYSTEMS INFUSION DEVICE
K
84
4915
IMED 980 VOLUMETRIC INFUSION PUMP
K
85
0098
SILVER SPOON ENTERAL FEEDING PUMP
K
84
1374
HOME PRO VOLUMETRIC INFUSION PUMP
K
84
4730
BARD HARVARD MINI-INFUSER 400 MULTI DOSE SYRINGE
K
84
4719
360 INFUSER
K
84
4718
MODEL 1001
K
84
4627
STRATOFUSE SYRINGE PIGGYBACK PUMP
K
84
4768
ABBOTT LIFECARE 500 INFUSER
K
84
4091
ABBOTT LIFECARE 900 VOLUMETRIC PUMP
K
84
4851
MINIMED EXTERNAL INFUSION PUMP FOR DIAGETICS 504
K
84
4792
MINIMED EXTERNAL INFUSION PUMP FOR DIABETICS 502A
K
84
4078
PROVIDER PA 3000 INFUSION SYSTEM
K
84
3878
HEPARIN INFUSIN PUMP
K
84
3773
CADD-PAC 5200 AMBULATORY INFUSION PUMP
K
84
3772
CADD-1 5100 AMBULATORY INFUSION PUMP
K
84
3949
I.V. PUMP ADMINISTRATION SET
K
84
3331
INTERMEDICS/GRASEBY DYNAMICS MS 36
K
84
2479
I.V. TEAMATE
K
84
3616
AVI GUARDIAN 400 INFUSION PUMP
K
84
3615
AVI GUARDIAN MICRO 410 INFUSION PUMP
K
84
3548
INTERMEDICS SYRINGE PUMP 710-02
K
84
3168
ENTERAL FEEDING PUMP 14-800 SERIES
K
84
3274
MODULAR VOLUMETRIC INFUSION PUMP SYS
K
84
2568
RADIONUCLIDE INFUSION SYSTEM
K
84
2421
ARGYLE ENTERITE ENTERAL FEEDING PUMP
K
84
1827
ENTEROPORT NUTRITION PUMP
K
84
2289
SR- MODEL 230
K
84
2263
MTP E.V. INFUSION PUMP
K
84
2027
IVAC 3080 ENTERAL FEEDING PUMP
K
84
1922
ACCUPRO VOLUMETRIC INFUSION PUMP W/RS232
K
84
1784
FLEXIFLO-III PORTABLE ENTERAL NUTRI
K
84
1630
ENTERAL NUTRITION PUMP
K
84
1729
ACCUPRO ENTERAL FEEDING PUMP
K
84
1512
ETHOX RELIA-FLO 2001 ENTERAL FEED
K
84
1481
WINDSOR MEDICAL MODEL 50-00002
K
84
1373
PROVIDER IV MODEL 2000 INFUSIN SYS
K
84
1017
PROVIDER INFUSION SET
K
83
3983
PROVIDER U-100 INSULIN INFUSION SYS
K
84
1018
PANCRETEC PUMP CHECK
K
84
0616
MINI-PUMP U-100
K
83
2470
INFUSION PUMP
K
84
0263
LIFECARE 4/HOMECARE - 4H PUMP
K
83
4461
INFUSION PUMP PRIMER
K
83
3723
MODEL 2000 AMBULATORY MED. INFUSER
K
83
3958
FLO-GARD 8100 INFUSION PUMP
K
83
3655
GILLETTE SABRE SYRINGE
K
83
2285
VOLUMETRIC PUMP SET 2C9100 FOR NITROGLY
K
83
2606
WINDSOR MEDICAL VARIOUS MODELS
K
83
3306
BETATRON I AMBULATORY INSULIN PUMP
K
83
2350
INTRABIONIC CO. - MICRO SYRINGE
K
83
2349
PROGRAMED
K
83
2923
AMBULATORY INSULIN INFUSION PUMP
K
83
2755
INFUSION PUMP & IV SETS #4000
K
83
2641
WINDSOR MEDICAL MODEL 52
K
83
0657
AMBULATORY MARK XI DRUG INFUSION DEV-
K
83
2410
GRASEBY DYNAMICS MS302 SYRINGE DRIVER
K
83
2289
LIFECARE MICRO PUMP
K
83
1534
PUMPETTE AS8P-INFUSION PUMP
K
83
1444
SINGLE USE SYRINGE #103 PERSONAL MEDIC
K
83
0389
ACCU-RYNGE PUMP SP-250
K
83
2166
FLO-GARD 8500 MICROINFUSION PUMP
K
83
2167
CORPAK VTR 300 ENTERNAL PUMP
K
83
0656
AMBULATORY MARK III INFUSION DEVICE
K
83
2120
PROMINJET PUMP
K
83
2008
INFUTROL 7000 INFUSION PUMP
K
83
1897
BETA I PROGRAMMABLE INFUSION PUMP
K
83
1761
SIMPLICITY PLUS
K
83
1935
ENTERNAL PUMP & ADMIN. SET 430
K
83
1258
FLO-GARD 6100 VOLUMETRIC INFUSION PUMP
K
83
0906
PULSAMAT MODEL 1050
K
83
1203
Y-TYPE BACKCHECK MICROBORE EXTEN. SET
K
83
1259
RESERVOIR 1.5CC #9210 W/25 GAUGE/NEEDLE
K
83
0809
GRASE BY DYNAMICS MS 27 SYRINGE DRIVER
K
83
0452
PCA PUMP
K
83
0486
INFUSION PUMP #AS*6H
K
83
0936
TREONIC IP5
K
83
0605
PUMP PALL AMBULATORY INSULIN INFUSION
K
83
0544
WINDSOR MEDICAL, INC. 50-01-028
K
83
0454
IMS MINIATURE VOLUMETRIC INFUSION PUMP
K
83
0490
MODEL 50-01-27
K
83
0570
PERSONAL MEDICATION INFUSER
K
82
2842
AMBULATORY MARK I
K
83
0423
SYRINGE DRIVER MS-16
K
83
0355
SECURA IV VOLUMETRIC INFUSION PUMP
K
83
0102
HARVARD APPARATUS INTERMITTENT INFUSION
K
83
0151
EXTERNAL INFUSION PUMP
K
83
0177
HARVARD APPARATUS FAMILY OF FLUID INFUS
K
83
0038
SIGMA 7000-6000 INFUSION PUMPS
K
82
0038
SIGMA 7000
K
83
0017
VOLUMETRIC PUMP ADMIN. SETS
K
82
3406
GUARDIAN 110, VOL. CONTROL DELIV. SYS
K
82
3204
BETATRON II
K
82
3193
AMBULATORY INSULIN INFUSION PUMP 9205
K
82
3063
FLO-GARD 2000 ENTERNAL PUMP & TRAVASORB
K
82
3035
COMPUTER INTERFACE MODULE CIM
K
82
2989
HARVARD APPARATUS SINGLE SPEED SYRINGE
K
82
2454
SYRINGE PUMP 209-100
K
82
2571
SYRINGE PUMP
K
82
2761
DELIVERY TUBE SET #2226
K
82
1661
FLEXIFLO-II
K
82
1069
MODEL AS6M INFUSION PUMP
K
82
1148
ETHOX FOOD PUMP STAND W/POLE CLAMP
K
82
1047
IVAC 630 & VOLUMETRIC INFUSION PUMP
K
82
0946
AS 70 VOLUMETRIC INFUSION PUMP
K
82
0860
VOLUMETRIC PUMP CASSETTE W/ATTACHED SET
K
82
0764
IVAC MODEL 160 AIR-IN-LINE SENSOR
K
82
0726
ACCUSET (R) CASSETTE
K
82
0482
ACCU-RYNGE INSULIN PUMP #SP-250
K
81
3644
MODEL 2650 HIGH CAPACITY DUAL SYRINGE
K
82
0219
OPEN LOOP INFUSION PUMP
K
82
0063
KEOFEED 500 ENTERIC FEEDING PUMP
K
81
3562
SYRINGE DRIVER 209
K
81
3590
MODEL AS6B INFUSION PUMP
K
82
0073
OPEN LOOP AMBULATORY INSULIN INFUSION
K
81
3473
5B SLAVE MODULE SYRINGE PUMP
K
81
3455
PUMP & DETECTOR
K
81
3403
FLO-GARD 8000 INFUSION PUMP SYSTEM
K
81
2898
PE-01 ELECTRONIC INFUSION PUMP
K
81
2917
PORTABLE LIDOCAINE INFUSION PUMP
K
81
0850
PERSONAL MEDICATION INFUSER
K
81
2824
PRESSURE DISC COMPONENT FOR ACCUSET
K
81
2823
IMED MODEL 970 & 975 VOL. INFUSION PUMP
K
81
2499
INFUSION PUMP
K
81
2442
3M INFUSION SYSTEM
K
81
1783
ENDOPUMP
K
81
2339
TERUFUSION INFUSION PUMP MODEL STC-502
K
81
2042
INFUSION PUMP MODEL 200/201
K
81
2021
VOLUMETRIC INFUSION PUMP
K
81
2035
IMED ACCUSET CASSETTE
K
81
1917
I.V. ADMIN. SETS FOR THE AMP MARK IV PMP
K
81
1933
GUARDIAN, VOLUMETRIC CONTROL DELIVERY
K
81
1918
AMP MARK IV INFUSION PUMP
K
81
1884
IVAC 700 SYRINGE INFUSION PUMP
K
81
1774
OPEN LOOP AMBULATORY INFUSION DEVICE
K
81
1739
ENTRI ENTERAL FEEDING PUMP
K
81
1272
RAZEL MODEL C
K
80
3183
OFFENBACK REVERSIBLE BARIUM PUMP
K
81
1238
MODEL 560 SERIES VOLUMETRIC INFUSION
K
81
0295
COMPUTER INTERFACE MODULE
K
81
0252
STUMARK INFUSOR
K
80
3078
SIMPLICITY INFUSION PUMP MODEL 2100A
K
80
3190
ETHOX/BARRON #2000 FOOD PUMP-ENTERAL FED
K
80
2901
TRAVENOL INFUSION PUMP-2M8016
K
80
2400
MS 16 SYRINGE DRIVER
K
80
2820
TRAVENOL 24 HR. INFUSOR (ELASTOMERIC PP)
K
80
2301
CORDIS DOW INFUSION PUMP
K
80
1904
SYRINGE INFUSION PUMP #2716
K
80
1546
THE SIMPLICITY PUMP #2100 INFUSION PUMP
K
80
1725
KANGAROO ENTERAL FEEDING PUMP
K
80
1704
OPEN-LOOP INSULIN DELIVERY SYSTEM
K
80
1441
ABBOTT/SHAW LIFE CARE PUMP MODEL 3
K
80
0627
AMBULATORY INFUSION PUMP, CODE 2M9807
K
80
0629
INTRAVENOUS INFUSION PUMP, CODE 2M8015
K
80
0570
HEPARIN PUMP #7420
K
80
0569
SYRINGE INFUSION PUMP #2720
K
79
2050
3M SMALL VOLUME INFUSTION (SVI) SYSTEM
K
79
2142
MODEL IV 6500 FORMULATOR
K
79
1293
BATTERY POWERED SYRINGE INFUSION PUMP
K
79
1720
AR/MDE INFUSOR MODEL 60/2 INFUSION PUMP
K
79
1729
SYRINGE INFUSION PUMP
K
79
1528
FLEXIFO ENTERAL NUTRITION PUMP
K
79
0814
DELTA PUMP
K
79
0945
MODEL 113 TREONIC IP3 DIGITAL SYRINGE PU
K
79
0559
ALARM
K
79
0315
BLOOD CELL SEPARATOR SYSTEM CS3000
K
79
0373
IVAC 630 VOLUMETRIC INFUSION PUMP
K
79
0332
MODEL IV6000 INFUSION PUMP
K
78
2034
INFUSION PUMP, MODEL AS*5
K
78
2019
CUTTER 888-00 INFUSION PUMP
K
78
2020
INFUSION PUMP, MODEL 5000
K
78
1171
INFUSION PUMP, PEDIATRIC MODEL 301
K
78
0705
INFUSION PUMP-MODEL 2616
K
78
0503
INFUSION PUMP
K
78
0086
INFUSION APPARATUS, POWERED
K
77
2094
LIFECARE I.V. PUMP - MODEL III
K
77
1300
INTRAVENOUS INFUSION PUMP
K
77
1664
VOLUMETRIC INFUSION PUMP MODEL 960
K
77
1478
INFUSION PUMP #6202
K
77
0849
VOLUMET INFUSION PUMP, MODIFI. OF
K
77
0730
PUMP, INFUSION, DYNATECH/HANDLEY
K
77
0087
I.V. PUMP, ABBOTT/SHAW LIFECARE
K
76
1307
AUTO SYRINGE MODEL AS-3A
K
76
1151
INFUSION PUMP
K
76
0718
PERISTALTIC INFUSION PUMP (2100,2101)
K
76
0370
INFUSION EQUIPMENT, INTRAVENOUS
FRP
Holder, Infant Position
FRR
Chamber, Reverse Isolation, Patient Care
FSA
Lift, Patient, Non-Ac-Powered
FSD
Binder, Abdominal
HEF
Binder, Breast
HFS
Shield, Nipple
IKY
Mattress, Flotation Therapy, Non-Powered
KMK
Device, Intravascular Catheter Securement
KMO
Binder, Elastic
KPE
Container, I.V.
KYP
Snake Bite Suction Kit
KYQ
Kit, Chemical Snake-Bite
KZD
Infusor, Pressure, For I.V. Bags
KZE
Injector, Fluid, Non-Electrically Powered
LBI
Unit, Neonatal Phototherapy
LDR
Controller, Infusion, Intravascular, Electronic
LGM
Chamber, Patient Isolation
LGN
Chamber, Patient Transport Isolation
LGZ
Warmer, Thermal, Infusion Fluid
LHF
Warmer, Microwave, Infusion Fluid
LHI
Set, I.V. Fluid Transfer
LJL
Detectors And Removers, Lice, (Including Combs)
LJS
Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
LJT
Port & Catheter, Implanted, Subcutaneous, Intravascular
LLI
Bed, Therapeutic, Ac-Powered, Adjustable Home-Use
LLK
Legging, Compression, Non-Inflatable
LZH
Pump, Infusion, Enteral
MDR
Binder, Medical, Therapeutic
MEA
Pump, Infusion, Pca
MEB
Pump, Infusion, Elastomeric
MEG
Syringe, Antistick
MHC
Needle, Interosseous
MHD
Pump, Infusion, Gallstone Dissolution
MJF
Check Valve, Retrograde Flow (In-Line)
MMK
Container, Sharps
MQX
Needle, Acupuncture, Single Use
MRZ
Accessories, Pump, Infusion
MZR
Topical Approximation System
NEP
System/Device, Pharmacy Compounding
NGT
Saline, Vascular Access Flush
NKK
Needle, Hypodermic, Single Lumen, Reprocessed
NKN
Syringe, Piston, Reprocessed
NRW
Stimulator, Intramuscular, Automatic
NSC
Injector, Pen
NTC
Nursing Pad, Hydrogel
NTX
Nursing Pad, Polyurethane Pad With Starch Copolymer, Glycerin, And Surfactant (F-68)
NXH
Nursing Pad, Cohesive Gel
NZG
Bassinet, Hospital
NZW
Heparin, Vascular Access Flush
NZX
Water, Vascular Access Flush
OBK
Port, Protector/Cushion
ODI
Administration Set Docking Station
ODY
Tunneled Catheter Remover
OJA
Intravenous Extension Tubing Set
OKC
Implanted Subcutaneous Securement Catheter
OKE
Port Introducer Kit
OKL
Intravascular Administration Set, Automated Air Removal System
OMF
Percutaneous, Implanted, Long-Term Intravascular Catheter Accessory For Catheter Position
ONB
Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System
ONM
Radiant Infant Warmer Cabinet
PUK
Administration Set Securement Device
OPP
Pump, Infusion, Insulin Bolus
OSI
Bariatric Bed
OUW
Infant Positioner, Rx, Use In Highly Monitored Setting
OWL
Peripheral Catheter Insertion Kit
PDH
Blanket, Neonatal Phototherapy
PEF
Heparin Flush In 0.45% Sodium Chloride
PEZ
Central Venous Catheter Dressing Change Kit
PHC
Infusion Safety Management Software
PKP
Immunoglobulin G (Igg) Infusion System
PMS
Peripheral Intravenous (Piv) Infiltration Monitor
PND
Midline Catheter
POQ
Blood Transfusion Kit
POR
Parenteral Administration Kit
PQH
Iodinated Contrast Media Transfer Tubing Set
PQX
Epinephrine Syringe
PRN
Pediatric Position Holder
PTD
Subcutaneous Implanted Apheresis Port
PTI
Non-Coring (Huber) Needle
PUN
Lice Removal Kit Containing A Solution
PUR
Vacuum Syringe
PVZ
Non-Stainless Steel Needle
PWH
Administrations Sets With Neuraxial Connectors
PWN
Baby Care Kit
PWO
Blood Administration Kit
PWQ
Buret Administration Intravenous Kit
PWR
Catheter Repair Kit
PWX
Insect Sting Emergency Kit
PWY
Lumbar Puncture Tray (Adult & Pediatric)
PXB
Percutaneous Introducer Kit
PXI
Thoracentesis Tray
PXJ
Umbilical Catheter Insertion Tray
PXK
Vascular Access Port Kit
PXL
Venipuncture Kit
PYR
Neuraxial Administration Set - Intrathecal Delivery
PZW
Catheter Access Cover, Tamper-Resistant
QBL
Piston Syringe Lever
QDM
Midazolam Syringe
QEH
Piston Syringe With Neuraxial Connector – Epidural, Peripheral, And/Or Indirect Cerebral Spinal Fluid Contact
QJY
Infusion Pump, Drug Specific, Pharmacy-Filled
QLF
On-Body Injector
QLY
Ophthalmic Syringe
QMT
Prep Kit – Vaccine Injection
QNQ
Low Dead Space Piston Syringe
QNS
Low Dead Space Needle, Single Lumen, Hypodermic
QOG
Injection Data Capture Device
QOI
Intravenous Catheter Force-Activated Separation Device.
QTI
Saline Vascular Access Flush With Integrated Alcohol Disinfectant Device
QYM
Ophthalmic Needle
SCL
Allergen And Vaccine Delivery Needles
SEF
Central Venous Catheter With Manual Insertion System
Subpart F—Neurological Therapeutic Devices
Subpart F—Physical Medicine Therapeutic Devices
Subpart F—Therapeutic Devices
Subpart G—General Hospital and Personal Use Miscellaneous Devices
Subpart G—Miscellaneous Devices
Hematology
Immunology
Microbiology
Neurology
Obstetrical and Gynecological
Ophthalmic
Orthopedic
Pathology
Physical Medicine
Radiology
General and Plastic Surgery
Toxicology
Medical Genetics
Unknown
HO
/
subpart-f—general-hospital-and-personal-use-therapeutic-devices
/
FRN
/
K223607
View Source
Plum Duo™ Infusion System
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K223607
510(k) Type
Traditional
Applicant
ICU Medical, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
8/24/2023
Days to Decision
265 days
Submission Type
Summary