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Innolitics
Anesthesiology
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—Monitoring Devices
CFR Sub-Part
Subpart D—Prosthetic Devices
CFR Sub-Part
Subpart E—Surgical Devices
CFR Sub-Part
Subpart F—Cardiovascular Therapeutic Devices
CFR Sub-Part
Subpart F—Neurological Therapeutic Devices
CFR Sub-Part
Subpart F—Physical Medicine Therapeutic Devices
CFR Sub-Part
Subpart F—Therapeutic Devices
CFR Sub-Part
BRW
Protector, Dental
1
Product Code
BSF
Absorber, Carbon-Dioxide
1
Product Code
BSJ
Mask, Gas, Anesthetic
1
Product Code
BSK
Cuff, Tracheal Tube, Inflatable
2
Product Code
BSN
Filter, Conduction, Anesthetic
2
Product Code
BSO
Catheter, Conduction, Anesthetic
2
Product Code
BSP
Needle, Conduction, Anesthetic (W/Wo Introducer)
2
Product Code
BSR
Stylet, Tracheal Tube
1
Product Code
BSZ
Gas-Machine, Anesthesia
2
Product Code
BTB
Hook, Ether
1
Product Code
BTC
Bag, Reservoir
1
Product Code
BTK
Strap, Head, Gas Mask
1
Product Code
BTL
Ventilator, Emergency, Powered (Resuscitator)
2
Product Code
BTM
Ventilator, Emergency, Manual (Resuscitator)
2
Product Code
BTO
Tube, Tracheostomy (W/Wo Connector)
2
Product Code
BTP
Dropper, Ether
1
Product Code
BTQ
Airway, Nasopharyngeal
1
Product Code
BTR
Tube, Tracheal (W/Wo Connector)
2
Product Code
BTS
Tube, Bronchial (W/Wo Connector)
2
Product Code
BTT
Humidifier, Respiratory Gas, (Direct Patient Interface)
2
Product Code
BWB
Forceps, Tube Introduction
1
Product Code
BWC
Needle, Emergency Airway
2
Product Code
BWF
Spirometer, Therapeutic (Incentive)
2
Product Code
BWL
Apparatus, Electronanesthesia
3
Product Code
BYD
Condenser, Heat And Moisture (Artificial Nose)
1
Product Code
BYE
Attachment, Breathing, Positive End Expiratory Pressure
2
Product Code
BYF
Mask, Oxygen, Low Concentration, Venturi
1
Product Code
BYG
Mask, Oxygen
1
Product Code
BYH
Drain, Tee (Water Trap)
1
Product Code
BYI
Percussor, Powered-Electric
2
Product Code
BYJ
Unit, Liquid-Oxygen, Portable
2
Product Code
BYK
Tent, Oxygen, Electrically Powered
2
Product Code
BYL
Tent, Oxygen
1
Product Code
BYN
Chair, Posture, For Cardiac And Pulmonary Treatment
1
Product Code
BYO
Bottle, Blow
1
Product Code
BYP
Mouthpiece, Breathing
1
Product Code
BYT
Ventilator, External Body, Negative Pressure, Adult (Cuirass)
2
Product Code
BYW
Device, Rebreathing
1
Product Code
BYX
Tubing, Pressure And Accessories
1
Product Code
BZA
Connector, Airway (Extension)
1
Product Code
BZB
Catheter, Nasal, Oxygen
1
Product Code
BZD
Ventilator, Non-Continuous (Respirator)
2
Product Code
BZE
Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer
2
Product Code
BZO
Set, Tubing And Support, Ventilator (W Harness)
1
Product Code
BZR
Mixer, Breathing Gases, Anesthesia Inhalation
2
Product Code
CAD
Vaporizer, Anesthesia, Non-Heated
2
Product Code
CAE
Airway, Oropharyngeal, Anesthesiology
1
Product Code
CAF
Nebulizer (Direct Patient Interface)
2
Product Code
CAG
Circulator, Breathing-Circuit
2
Product Code
CAI
Circuit, Breathing (W Connector, Adaptor, Y Piece)
1
Product Code
CAL
Laryngoscope, Non-Rigid
1
Product Code
CAO
Airway, Esophageal (Obturator)
2
Product Code
CAT
Cannula, Nasal, Oxygen
1
Product Code
CAW
Generator, Oxygen, Portable
2
Product Code
CAZ
Anesthesia Conduction Kit
2
Product Code
CBF
Chamber, Hyperbaric
2
Product Code
CBG
Spreader, Cuff
1
Product Code
CBH
Device, Fixation, Tracheal Tube
1
Product Code
CBI
Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)
2
Product Code
CBK
Ventilator, Continuous, Facility Use
2
Product Code
CBL
Absorbent, Carbon-Dioxide
1
Product Code
CBN
Apparatus, Gas-Scavenging
2
Product Code
CBO
Attachment, Intermittent Mandatory Ventilation (Imv)
2
Product Code
CBP
Valve, Non-Rebreathing
2
Product Code
MOD
Accessory To Continuous Ventilator (Respirator)
2
Product Code
CCO
Bed, Rocking, Breathing Assist
2
Product Code
CCQ
Nebulizer, Medicinal, Non-Ventilatory (Atomizer)
1
Product Code
CCT
Applicator (Laryngo-Tracheal), Topical Anesthesia
2
Product Code
CCW
Laryngoscope, Rigid
1
Product Code
EPE
Brush, Cleaning, Tracheal Tube
1
Product Code
FNC
Tent, Pediatric Aerosol
2
Product Code
FOG
Hood, Oxygen, Infant
1
Product Code
JAY
Support, Breathing Tube
1
Product Code
JOH
Tube Tracheostomy And Tube Cuff
2
Product Code
K
21
0833
Portex BLUxl Extra Length Tracheostomy Tube, BLUxl Suctionaid Extra Length Tracheostomy Tube, BLUxl Extra Length Tracheostomy Inner Cannula
2
Cleared 510(K)
K
20
3362
TRACOE vario
2
Cleared 510(K)
K
19
3077
Shiley Adult Flexible Evac Tracheostomy Tube with TaperGuard Cuff
2
Cleared 510(K)
K
19
3133
Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Set, Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Tray, Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set, Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Tray, Weinmann-Multi Percutaneous Tracheostomy Exchange Set
2
Cleared 510(K)
K
18
2861
Shiley Neonatal/Pediatric Tracheostomy Tube
2
Cleared 510(K)
K
17
3912
BLUperc Percutaneous Dilation Tracheostomy Kit with BLUselect tube, BLUperc Percutaneous Dilation Tracheostomy Kit with BLUselect Suctionaid tube, BLUgriggs Percutaneous Dilation Tracheostomy Kit with BLUselect tube, BLUgriggs Percutaneous Dilation Tracheostomy Kit with BLUselect Suctionaid tube
2
Cleared 510(K)
K
18
0034
Weinmann Tracheostomy Exchange Set
2
Cleared 510(K)
K
17
2720
TRACOE silcosoft Tracheostomy Tube
2
Cleared 510(K)
K
17
0720
Portex Blue Line Ultra Paediatric Tracheosomy Tube
2
Cleared 510(K)
K
15
1404
ProTrach Dualcare
2
Cleared 510(K)
K
15
0844
Shiley Adult Flexible Tracheostomy Tube Cuffless, Reusable Inner Cannula, Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff, Reusable Inner Cannula
2
Cleared 510(K)
K
14
2296
Shiley Adult Flexible Tracheostomy Tube Cuffless, Disposable Inner Cannula; Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff, Disposable Inner Cannula
2
Cleared 510(K)
K
14
2298
Shiley Neonatal, Pediatric & Pediatric Long Tracheostomy Tubes with TaperGuard Cuff
2
Cleared 510(K)
K
13
3528
H&H EMERGENCY CRICOTHYROTOMY KIT
2
Cleared 510(K)
K
13
3173
RUSCH TRACFLEX PLUS PEDIATRIC TRACHEOSTOMY TUBE SET
2
Cleared 510(K)
K
13
3597
CIAGLIA PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET/TRAY, CIAGLIA BLUE RHINO PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET/TRAY
2
Cleared 510(K)
K
12
2932
SPIRO SPEAKING VALVE WITH OXYGEN PORT SPIRO SPEAKING VALVE WITHOUT OXYGEN PORT
2
Cleared 510(K)
K
12
2235
RUSCH TRACFLEX PLUS TRACHEOSTOMY TUBE SET
2
Cleared 510(K)
K
12
3699
FAHL TRACHEOSTOMY TUBES (MULTIPLE)
2
Cleared 510(K)
K
12
2531
SHILEY NEONATAL TRACHEOSTOMY TUBE CUFFLESS, SHILEY PEDIATRIC TRACHEOSTOMY TUBE CUFFLESS, SHILEY PEDIATRIC TRACHEOSTOMY T
2
Cleared 510(K)
K
10
0995
SHIKANI SPEAKING VALVE
2
Cleared 510(K)
K
09
3469
CIAGLIA BLUE DOLPHIN BALLOON PERCUTANEOUS TRACHEOSTOMY INTRODUCER, MODEL: MULTIPLE, PREFIX C-PTBS
2
Cleared 510(K)
K
08
3641
BIVONA TRACHEOSTOMY TUBES
2
Cleared 510(K)
K
08
1440
BIVONA ADJUSTABLE AND FIXED NECKFLANGE HYPERFLEX TRACHEOSTOMY TUBES
2
Cleared 510(K)
K
07
2582
PROVOX MICRON HME
2
Cleared 510(K)
K
07
2148
CIAGLIA BLUE DOLPHIN (TM) BALLOON PERCUTANEOUS TRACHEOSTOMY INTRODUCER
2
Cleared 510(K)
K
05
1416
SHILEY TRACHEOSOFT XLT EXTENDED LENGTH TRACHEOSTOMY TUBE AND INNER CANNULA
2
Cleared 510(K)
K
04
3160
TRACOE PHON ASSIST I - SPEAKING VALVES, REFERENCE MODELS: PHON ASSIST I-650-T/TO AND 650-S/SO
2
Cleared 510(K)
K
04
1485
MARPAC MESSENGER MODEL #501
2
Cleared 510(K)
K
04
1044
CIAGLIA CHEETAH PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET
2
Cleared 510(K)
K
04
1348
PORTEX ULTRAPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT_WITH SERIAL DILATORS OR SINGLE STAGE DILATOR, BLUE LINE ULTRA
2
Cleared 510(K)
K
04
0014
PERCUTANEOUS DILATION TRACHEOSTOMY KIT WITH SINGLE STAGE DILATOR AND SOFT INTRODUCERS FOR SIZES 7, 8 AND 9MM TUBES ONLY
2
Cleared 510(K)
K
03
0787
SHILEY FLEXTRA TRACHEOSTOMY TUBE
2
Cleared 510(K)
K
03
1057
PER-FIT PERCUTANEOUS DILATIONAL TRACHEOSTOMY KIT
2
Cleared 510(K)
K
02
3918
RUSCH CRYSTAL CLEAR TRACHEOSTOMY SETS, CUFFED AND CUFFLESS
2
Cleared 510(K)
K
02
2212
PORTEX PERCUTANEOUS DILATATIONAL TRACHEOSTOMY KITS
2
Cleared 510(K)
K
01
3728
TRACH VOX
2
Cleared 510(K)
K
01
4102
PROVOX HME CASSETTE, MODEL 7240; PROVOX ADHESIVE, MODEL 7251
2
Cleared 510(K)
K
01
1210
THE PERCUQUICK SET FOR PERCUTANEOUS DILATION TRACHEOSTOMY
2
Cleared 510(K)
K
00
3315
SHILEY TRACHEOSOFT XLT EXTENDED LENGTH TRACHEOSTOMY TUBE AND DISPOSABLE INNER CANNULA
2
Cleared 510(K)
K
00
0964
STERILE WATER OR O.9% SODIUM CHLORIDE, MODEL AL4100 & AL4109
2
Cleared 510(K)
K
99
0905
PASSY-MUIR LOW-PROFILE TRACHEOSTOMY SPEAKING VALVE PMV 2020 (CLEAR) JIT
2
Cleared 510(K)
K
97
0811
DISPOSABLE CANNULA TRACHEOSTOMY TUBE, WITH INNER CANNULA;DISPOSABLE CANNULA FENESTRATED TRACHEOSTOMY TUBE, WITH INNER CN
2
Cleared 510(K)
K
98
2128
SHIKANI-FRENCH SPEAKING VALVE
2
Cleared 510(K)
K
97
2546
RUSCH SINGLE USE CRYSTAL TRACHEOSTOMY TUBE SET
2
Cleared 510(K)
K
98
0466
PER-FIT PERCUTANEOUS DILATIONAL TRACHEOSTOMY KIT WITH SPECIALTY TRACHEOSTOMY TUBE AND DISPOSABLE INNER CANNULA
2
Cleared 510(K)
K
97
3829
IRRIGATION BOTTLE
2
Cleared 510(K)
K
97
2423
RUSCH TRACHEOFIX-SET
2
Cleared 510(K)
K
97
2385
FENESTRATED FLEXIBLE D.I.C. TRACHEOSTOMY TUBE CUFFED
2
Cleared 510(K)
K
96
4056
RUSCH ULTRA TRACHEOFLEX FENESTRATED KIT CUFFED,UNCUFFED/ RUSCH TRACHEOFLEX TRACHEOSTOMY KIT UNCUFFED STERILE
2
Cleared 510(K)
K
97
1267
SHILEY EXTENDED LENGTH, DISPOSABLE CANNULA, TRACHEOSTOMY TUBE: CUFFED, DISTAL EXTENSION, CUFFED, PROXIMAL EXTENSION, CUF
2
Cleared 510(K)
K
96
3732
PERCUTANEOUS DUAL CANNULA TRACHEOSTOMY TUBE WITH LOW PRESSURE/LOW PROFILE CUFF AND DISPOSABLE INNER CANNULA
2
Cleared 510(K)
K
97
0365
PASSY-MUIR O2 ADAPTER; PMA2000
2
Cleared 510(K)
K
96
2175
PORTEX ADJUSTABLE FLANGE TRACHEOSTOMY TUBE
2
Cleared 510(K)
K
96
2714
PASSY-MUIR LOW-PROFILE TRACHEOSTOMY AND VENTILATOR SPEAKING VALVE; PRODUCT NUMBER PMV 2000 OR PMTSV 2000
2
Cleared 510(K)
K
96
2078
TRACHEOSTOMY CLEANING TRAY W/SUCTION CATHETER
2
Cleared 510(K)
K
96
2173
SHIKEY TRACHEOSTOMY TUBES AND ACCESSORIES
2
Cleared 510(K)
K
96
1449
TRACHEOSTOMY TUBES TRACOE-FLEX
2
Cleared 510(K)
K
95
5564
RUSCH ULTRA TRACHEOFLEX TRACHEOSTOMY SET, CUFFED, STERILE
2
Cleared 510(K)
K
96
0429
PER-FIT PERCUTANEOUS TRACHEOSTOMY KIT W/PORTEX TRACHEOSTMY TUBE & DISP. INNER CANNULA
2
Cleared 510(K)
K
95
5680
SHILEY CUFFED PEDIATRIC TRACHEOSTOMY TUBE; LONG CUFFED
2
Cleared 510(K)
K
95
4749
MALLINCKRODT SHILEY 15MM CAP
2
Cleared 510(K)
K
95
4661
THE ZIPPER MEDICAL COMBINATION VENTILATOR ANTI-DISCONNCET DEVICE & TRACHEOSTOMY TUBE NECKBAND. TRACHEOSTOMY TUBE HOLDER,
2
Cleared 510(K)
K
95
5516
MONTGOMERY TRACHEOSTOMY SPEAKING VALVE
2
Cleared 510(K)
K
95
2700
SUPERSLICK
2
Cleared 510(K)
K
94
4451
PASSY-MUIR TRACHEOSTOMY SPEAKING VALVES (ONE-WAY TRACHEOSTOMY SPEAKING VALVES)
2
Cleared 510(K)
K
94
5513
MALLINCKRODT SHILEY NEONATAL, PEDIATRIC, LONG PEDIATRIC TRACHEOSTOMY TUBE
2
Cleared 510(K)
K
94
5874
EUROMEDICAL POLY TRACHEOTOMY TUBE
2
Cleared 510(K)
K
94
4178
BIVONA FLEXTEND PEDIATRIC & NEONATAL TRACHEOSTROMY TUBES
2
Cleared 510(K)
K
93
6224
REUSABLE CANNULA TRACHEOSTOMY TUBES, MODIFIED HEADS
2
Cleared 510(K)
K
92
1733
TRACHEOSTOMY CARE TRAY
2
Cleared 510(K)
K
93
6133
PERCUTANEOUS TRACHEOSTOMY KIT
2
Cleared 510(K)
K
93
2016
TRACHEOSTOMY CARE TRAY
2
Cleared 510(K)
K
93
3412
SALINE SOLUTION-STERILE
2
Cleared 510(K)
K
93
1611
PERCUTANEOUS TRACHEOSTOMY TUBE KIT
2
Cleared 510(K)
K
92
5288
TRACHEOSTOMY KIT
2
Cleared 510(K)
K
92
3156
TRACHEOSTOMY CARE TRAY
2
Cleared 510(K)
K
92
5020
TRACHEOSTOMY CARE KIT (STERILE)
2
Cleared 510(K)
K
93
0895
SHILEY FENESTRATED REUSABLE INNER CANNULA, MODIF
2
Cleared 510(K)
K
92
4243
TRACHEOSTOMY CARE KIT
2
Cleared 510(K)
K
92
5438
COMBINATION TRACH TIE & VENTILATOR ANTIDISCONNECT
2
Cleared 510(K)
K
92
2665
BIVONA HYPERFLEX TRACHEOSTOMY TUBE
2
Cleared 510(K)
K
92
3878
BIVONA CUSTOMIZED TRACHEOSTOMY TUBES
2
Cleared 510(K)
K
92
4660
TRACHEOSTOMY TUBE AND TUBE CUFF
2
Cleared 510(K)
K
91
4471
NEEDLECRIC
2
Cleared 510(K)
K
91
3859
BIVONA FOME-CUF(R) & AIR CUF(R), MODIFICATION
2
Cleared 510(K)
K
91
4183
BIVONA CUFF MAINTENANCE DEVICE (CMD)
2
Cleared 510(K)
K
91
4088
BIVONA AIRE-CUF(R) PEDIATRIC TRACHEOSTOMY TUBE
2
Cleared 510(K)
K
91
3270
BIVONA FOME-CUF(R) PEDIATRIC TRACHEOSTOMY TUBE
2
Cleared 510(K)
K
91
2967
BIVONA AIRE-CUF TRACHEOSTOMY TUBE W/TALK ATTACH.
2
Cleared 510(K)
K
91
1080
HYGIENA-TRACH
2
Cleared 510(K)
K
91
0362
TRACHEOSTOMY CARE KIT
2
Cleared 510(K)
K
90
3435
SHILEY SPECIALIZED TRACHEOSTOMY TUBE
2
Cleared 510(K)
K
90
3699
PASSY-MUIR TRACHEOSTOMY SPEAKING VALVE 15MM / 22MM
2
Cleared 510(K)
K
89
7102
HYDRASORB(TM)
2
Cleared 510(K)
K
89
7005
BLOM-SINGER(R) SILICONE LARYNGECTOMY TUBE
2
Cleared 510(K)
K
89
7059
HOOD SPEAKING VALVE
2
Cleared 510(K)
K
89
6547
MODIFIED FOME-CUF SILICONE TRACHEOSTOMY TUBE
2
Cleared 510(K)
K
89
6548
MODIFIED AIRE-CUF SILICONE TRACHEOSTOMY TUBE
2
Cleared 510(K)
K
89
4614
BIVONA AIRE-CUF ADJUSTABLE TRACHEOSTOMY TUBE
2
Cleared 510(K)
K
89
4613
BIVONA FOME-CUF ADJUSTABLE TRACHEOSTOMY TUBE
2
Cleared 510(K)
K
89
4050
MODIFIED DECANNULATION STOPPER
2
Cleared 510(K)
K
89
0194
SHILEY SPECIALIZED TRACHEOSTOMY TUBE
2
Cleared 510(K)
K
88
5129
MODIFIED FOME-CUF SILICONE TRACHEOSTOMY TUBE
2
Cleared 510(K)
K
88
5130
MODIFIED AIRE-CUF SILICONE TRACHEOSTOMY TUBE
2
Cleared 510(K)
K
81
2163
AIRE-CUF TRACHEOSTOMY TUBE
2
Cleared 510(K)
K
81
2302
SHILEY FENESTRATED LOW PRESS. CUFFED
2
Cleared 510(K)
K
76
0453
REGULATOR, PRESSURE, CUFF
2
Cleared 510(K)
KFZ
Humidifier, Non-Direct Patient Interface (Home-Use)
1
Product Code
KGB
Mask, Oxygen, Non-Rebreathing
1
Product Code
KHA
Mask, Scavenging
1
Product Code
LNZ
Changer, Tube, Endotracheal
2
Product Code
MIA
Needle, Spinal, Short Term
2
Product Code
MNS
Ventilator, Continuous, Non-Life-Supporting
2
Product Code
MNT
Ventilator, Continuous, Minimal Ventilatory Support, Facility Use
2
Product Code
MRN
Apparatus, Nitric Oxide Delivery
2
Product Code
MRO
Apparatus, Nitric Oxide, Backup Delivery
2
Product Code
MZT
Device, Heimlich Maneuver Assist
2
Product Code
NFB
Conserver, Oxygen
2
Product Code
NHJ
Device, Positive Pressure Breathing, Intermittent
2
Product Code
NHK
Resuscitator, Manual, Non Self-Inflating
2
Product Code
NMA
Tube, Tracheal, Reprocessed
2
Product Code
NMC
Mask, Ventilator, Non-Continuous, Reprocessed
2
Product Code
NMR
Needle, Spinal, Short Term, Reprocessed
2
Product Code
NNH
Needle, Conduction, Anesthesia, Reprocessed
2
Product Code
NOU
Continuous, Ventilator, Home Use
2
Product Code
NQY
Ventilator, Continuous, Minimal Ventilatory Support, Home Use
2
Product Code
NVO
Spacer, Direct Patient Interface
2
Product Code
NVP
Holding Chambers, Direct Patient Interface
2
Product Code
NXA
Tracheotomy Care Kit
2
Product Code
OBN
Humidifier, Respiratory, Mask (Direct Patient Interface)
2
Product Code
OFQ
Anesthesia Kit
2
Product Code
OFT
Spinal Epidural Anesthesia Kit
2
Product Code
OFU
Spinal Anesthesia Kit
2
Product Code
OFV
Regional Anesthesia Kit
2
Product Code
OGA
Brachial Plexus Anesthesia Kit
2
Product Code
OGB
Caudal Anesthesia Kit
2
Product Code
OGC
Continuous Brachial Plexus Block Tray
2
Product Code
OGD
Custom Anesthesia Tray
2
Product Code
OGE
Epidural Anesthesia Kit
2
Product Code
OGF
Glossopharyngeal Anesthesia Kit
2
Product Code
OGG
Humidifier Nebulizer Kit
2
Product Code
OGH
Laryngoscope Kit
1
Product Code
OGI
Nasal Endotracheal Tube Holder Kit
1
Product Code
OGJ
Nerve Block Tray
2
Product Code
OGL
Oxygen Administration Kit
2
Product Code
OLF
Medevac Use Oxygen Generator
2
Product Code
ONZ
Mechanical Ventilator
2
Product Code
OQU
Airway Monitoring System
2
Product Code
PHS
Oral Airway Assist
1
Product Code
PMB
External Airway
2
Product Code
QAV
High Flow/High Velocity Humidified Oxygen Delivery Device
2
Product Code
QBY
Positive Airway Pressure System
2
Product Code
QCX
Retrograde Intubation Set
2
Product Code
OZR
Intraoral Pressure Gradient Device
2
Product Code
QFB
Isocapnic Ventilation Device
2
Product Code
Subpart G—Miscellaneous
CFR Sub-Part
Cardiovascular
Review Panel
Chemistry
Review Panel
Dental
Review Panel
Ear, Nose, Throat
Review Panel
Gastroenterology and Urology
Review Panel
General Hospital
Review Panel
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 16 August 2024 at 11:05 pm
AN
/
subpart-f—therapeutic-devices
/
JOH
/
K944178
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BIVONA FLEXTEND PEDIATRIC & NEONATAL TRACHEOSTROMY TUBES
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K944178
510(k) Type
Traditional
Applicant
BIVONA MEDICAL TECHNOLOGIES
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
10/27/1994
Days to Decision
62 days
Submission Type
Summary
FDA Browser
by
Innolitics
Anesthesiology
Miscellaneous
Subpart B—Cardiovascular Diagnostic Devices
Subpart B—Diagnostic Devices
Subpart C—Cardiovascular Monitoring Devices
Subpart C—Monitoring Devices
Subpart D—Prosthetic Devices
Subpart E—Surgical Devices
Subpart F—Cardiovascular Therapeutic Devices
Subpart F—Neurological Therapeutic Devices
Subpart F—Physical Medicine Therapeutic Devices
Subpart F—Therapeutic Devices
BRW
Protector, Dental
BSF
Absorber, Carbon-Dioxide
BSJ
Mask, Gas, Anesthetic
BSK
Cuff, Tracheal Tube, Inflatable
BSN
Filter, Conduction, Anesthetic
BSO
Catheter, Conduction, Anesthetic
BSP
Needle, Conduction, Anesthetic (W/Wo Introducer)
BSR
Stylet, Tracheal Tube
BSZ
Gas-Machine, Anesthesia
BTB
Hook, Ether
BTC
Bag, Reservoir
BTK
Strap, Head, Gas Mask
BTL
Ventilator, Emergency, Powered (Resuscitator)
BTM
Ventilator, Emergency, Manual (Resuscitator)
BTO
Tube, Tracheostomy (W/Wo Connector)
BTP
Dropper, Ether
BTQ
Airway, Nasopharyngeal
BTR
Tube, Tracheal (W/Wo Connector)
BTS
Tube, Bronchial (W/Wo Connector)
BTT
Humidifier, Respiratory Gas, (Direct Patient Interface)
BWB
Forceps, Tube Introduction
BWC
Needle, Emergency Airway
BWF
Spirometer, Therapeutic (Incentive)
BWL
Apparatus, Electronanesthesia
BYD
Condenser, Heat And Moisture (Artificial Nose)
BYE
Attachment, Breathing, Positive End Expiratory Pressure
BYF
Mask, Oxygen, Low Concentration, Venturi
BYG
Mask, Oxygen
BYH
Drain, Tee (Water Trap)
BYI
Percussor, Powered-Electric
BYJ
Unit, Liquid-Oxygen, Portable
BYK
Tent, Oxygen, Electrically Powered
BYL
Tent, Oxygen
BYN
Chair, Posture, For Cardiac And Pulmonary Treatment
BYO
Bottle, Blow
BYP
Mouthpiece, Breathing
BYT
Ventilator, External Body, Negative Pressure, Adult (Cuirass)
BYW
Device, Rebreathing
BYX
Tubing, Pressure And Accessories
BZA
Connector, Airway (Extension)
BZB
Catheter, Nasal, Oxygen
BZD
Ventilator, Non-Continuous (Respirator)
BZE
Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer
BZO
Set, Tubing And Support, Ventilator (W Harness)
BZR
Mixer, Breathing Gases, Anesthesia Inhalation
CAD
Vaporizer, Anesthesia, Non-Heated
CAE
Airway, Oropharyngeal, Anesthesiology
CAF
Nebulizer (Direct Patient Interface)
CAG
Circulator, Breathing-Circuit
CAI
Circuit, Breathing (W Connector, Adaptor, Y Piece)
CAL
Laryngoscope, Non-Rigid
CAO
Airway, Esophageal (Obturator)
CAT
Cannula, Nasal, Oxygen
CAW
Generator, Oxygen, Portable
CAZ
Anesthesia Conduction Kit
CBF
Chamber, Hyperbaric
CBG
Spreader, Cuff
CBH
Device, Fixation, Tracheal Tube
CBI
Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)
CBK
Ventilator, Continuous, Facility Use
CBL
Absorbent, Carbon-Dioxide
CBN
Apparatus, Gas-Scavenging
CBO
Attachment, Intermittent Mandatory Ventilation (Imv)
CBP
Valve, Non-Rebreathing
MOD
Accessory To Continuous Ventilator (Respirator)
CCO
Bed, Rocking, Breathing Assist
CCQ
Nebulizer, Medicinal, Non-Ventilatory (Atomizer)
CCT
Applicator (Laryngo-Tracheal), Topical Anesthesia
CCW
Laryngoscope, Rigid
EPE
Brush, Cleaning, Tracheal Tube
FNC
Tent, Pediatric Aerosol
FOG
Hood, Oxygen, Infant
JAY
Support, Breathing Tube
JOH
Tube Tracheostomy And Tube Cuff
K
21
0833
Portex BLUxl Extra Length Tracheostomy Tube, BLUxl Suctionaid Extra Length Tracheostomy Tube, BLUxl Extra Length Tracheostomy Inner Cannula
K
20
3362
TRACOE vario
K
19
3077
Shiley Adult Flexible Evac Tracheostomy Tube with TaperGuard Cuff
K
19
3133
Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Set, Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Tray, Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set, Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Tray, Weinmann-Multi Percutaneous Tracheostomy Exchange Set
K
18
2861
Shiley Neonatal/Pediatric Tracheostomy Tube
K
17
3912
BLUperc Percutaneous Dilation Tracheostomy Kit with BLUselect tube, BLUperc Percutaneous Dilation Tracheostomy Kit with BLUselect Suctionaid tube, BLUgriggs Percutaneous Dilation Tracheostomy Kit with BLUselect tube, BLUgriggs Percutaneous Dilation Tracheostomy Kit with BLUselect Suctionaid tube
K
18
0034
Weinmann Tracheostomy Exchange Set
K
17
2720
TRACOE silcosoft Tracheostomy Tube
K
17
0720
Portex Blue Line Ultra Paediatric Tracheosomy Tube
K
15
1404
ProTrach Dualcare
K
15
0844
Shiley Adult Flexible Tracheostomy Tube Cuffless, Reusable Inner Cannula, Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff, Reusable Inner Cannula
K
14
2296
Shiley Adult Flexible Tracheostomy Tube Cuffless, Disposable Inner Cannula; Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff, Disposable Inner Cannula
K
14
2298
Shiley Neonatal, Pediatric & Pediatric Long Tracheostomy Tubes with TaperGuard Cuff
K
13
3528
H&H EMERGENCY CRICOTHYROTOMY KIT
K
13
3173
RUSCH TRACFLEX PLUS PEDIATRIC TRACHEOSTOMY TUBE SET
K
13
3597
CIAGLIA PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET/TRAY, CIAGLIA BLUE RHINO PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET/TRAY
K
12
2932
SPIRO SPEAKING VALVE WITH OXYGEN PORT SPIRO SPEAKING VALVE WITHOUT OXYGEN PORT
K
12
2235
RUSCH TRACFLEX PLUS TRACHEOSTOMY TUBE SET
K
12
3699
FAHL TRACHEOSTOMY TUBES (MULTIPLE)
K
12
2531
SHILEY NEONATAL TRACHEOSTOMY TUBE CUFFLESS, SHILEY PEDIATRIC TRACHEOSTOMY TUBE CUFFLESS, SHILEY PEDIATRIC TRACHEOSTOMY T
K
10
0995
SHIKANI SPEAKING VALVE
K
09
3469
CIAGLIA BLUE DOLPHIN BALLOON PERCUTANEOUS TRACHEOSTOMY INTRODUCER, MODEL: MULTIPLE, PREFIX C-PTBS
K
08
3641
BIVONA TRACHEOSTOMY TUBES
K
08
1440
BIVONA ADJUSTABLE AND FIXED NECKFLANGE HYPERFLEX TRACHEOSTOMY TUBES
K
07
2582
PROVOX MICRON HME
K
07
2148
CIAGLIA BLUE DOLPHIN (TM) BALLOON PERCUTANEOUS TRACHEOSTOMY INTRODUCER
K
05
1416
SHILEY TRACHEOSOFT XLT EXTENDED LENGTH TRACHEOSTOMY TUBE AND INNER CANNULA
K
04
3160
TRACOE PHON ASSIST I - SPEAKING VALVES, REFERENCE MODELS: PHON ASSIST I-650-T/TO AND 650-S/SO
K
04
1485
MARPAC MESSENGER MODEL #501
K
04
1044
CIAGLIA CHEETAH PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET
K
04
1348
PORTEX ULTRAPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT_WITH SERIAL DILATORS OR SINGLE STAGE DILATOR, BLUE LINE ULTRA
K
04
0014
PERCUTANEOUS DILATION TRACHEOSTOMY KIT WITH SINGLE STAGE DILATOR AND SOFT INTRODUCERS FOR SIZES 7, 8 AND 9MM TUBES ONLY
K
03
0787
SHILEY FLEXTRA TRACHEOSTOMY TUBE
K
03
1057
PER-FIT PERCUTANEOUS DILATIONAL TRACHEOSTOMY KIT
K
02
3918
RUSCH CRYSTAL CLEAR TRACHEOSTOMY SETS, CUFFED AND CUFFLESS
K
02
2212
PORTEX PERCUTANEOUS DILATATIONAL TRACHEOSTOMY KITS
K
01
3728
TRACH VOX
K
01
4102
PROVOX HME CASSETTE, MODEL 7240; PROVOX ADHESIVE, MODEL 7251
K
01
1210
THE PERCUQUICK SET FOR PERCUTANEOUS DILATION TRACHEOSTOMY
K
00
3315
SHILEY TRACHEOSOFT XLT EXTENDED LENGTH TRACHEOSTOMY TUBE AND DISPOSABLE INNER CANNULA
K
00
0964
STERILE WATER OR O.9% SODIUM CHLORIDE, MODEL AL4100 & AL4109
K
99
0905
PASSY-MUIR LOW-PROFILE TRACHEOSTOMY SPEAKING VALVE PMV 2020 (CLEAR) JIT
K
97
0811
DISPOSABLE CANNULA TRACHEOSTOMY TUBE, WITH INNER CANNULA;DISPOSABLE CANNULA FENESTRATED TRACHEOSTOMY TUBE, WITH INNER CN
K
98
2128
SHIKANI-FRENCH SPEAKING VALVE
K
97
2546
RUSCH SINGLE USE CRYSTAL TRACHEOSTOMY TUBE SET
K
98
0466
PER-FIT PERCUTANEOUS DILATIONAL TRACHEOSTOMY KIT WITH SPECIALTY TRACHEOSTOMY TUBE AND DISPOSABLE INNER CANNULA
K
97
3829
IRRIGATION BOTTLE
K
97
2423
RUSCH TRACHEOFIX-SET
K
97
2385
FENESTRATED FLEXIBLE D.I.C. TRACHEOSTOMY TUBE CUFFED
K
96
4056
RUSCH ULTRA TRACHEOFLEX FENESTRATED KIT CUFFED,UNCUFFED/ RUSCH TRACHEOFLEX TRACHEOSTOMY KIT UNCUFFED STERILE
K
97
1267
SHILEY EXTENDED LENGTH, DISPOSABLE CANNULA, TRACHEOSTOMY TUBE: CUFFED, DISTAL EXTENSION, CUFFED, PROXIMAL EXTENSION, CUF
K
96
3732
PERCUTANEOUS DUAL CANNULA TRACHEOSTOMY TUBE WITH LOW PRESSURE/LOW PROFILE CUFF AND DISPOSABLE INNER CANNULA
K
97
0365
PASSY-MUIR O2 ADAPTER; PMA2000
K
96
2175
PORTEX ADJUSTABLE FLANGE TRACHEOSTOMY TUBE
K
96
2714
PASSY-MUIR LOW-PROFILE TRACHEOSTOMY AND VENTILATOR SPEAKING VALVE; PRODUCT NUMBER PMV 2000 OR PMTSV 2000
K
96
2078
TRACHEOSTOMY CLEANING TRAY W/SUCTION CATHETER
K
96
2173
SHIKEY TRACHEOSTOMY TUBES AND ACCESSORIES
K
96
1449
TRACHEOSTOMY TUBES TRACOE-FLEX
K
95
5564
RUSCH ULTRA TRACHEOFLEX TRACHEOSTOMY SET, CUFFED, STERILE
K
96
0429
PER-FIT PERCUTANEOUS TRACHEOSTOMY KIT W/PORTEX TRACHEOSTMY TUBE & DISP. INNER CANNULA
K
95
5680
SHILEY CUFFED PEDIATRIC TRACHEOSTOMY TUBE; LONG CUFFED
K
95
4749
MALLINCKRODT SHILEY 15MM CAP
K
95
4661
THE ZIPPER MEDICAL COMBINATION VENTILATOR ANTI-DISCONNCET DEVICE & TRACHEOSTOMY TUBE NECKBAND. TRACHEOSTOMY TUBE HOLDER,
K
95
5516
MONTGOMERY TRACHEOSTOMY SPEAKING VALVE
K
95
2700
SUPERSLICK
K
94
4451
PASSY-MUIR TRACHEOSTOMY SPEAKING VALVES (ONE-WAY TRACHEOSTOMY SPEAKING VALVES)
K
94
5513
MALLINCKRODT SHILEY NEONATAL, PEDIATRIC, LONG PEDIATRIC TRACHEOSTOMY TUBE
K
94
5874
EUROMEDICAL POLY TRACHEOTOMY TUBE
K
94
4178
BIVONA FLEXTEND PEDIATRIC & NEONATAL TRACHEOSTROMY TUBES
K
93
6224
REUSABLE CANNULA TRACHEOSTOMY TUBES, MODIFIED HEADS
K
92
1733
TRACHEOSTOMY CARE TRAY
K
93
6133
PERCUTANEOUS TRACHEOSTOMY KIT
K
93
2016
TRACHEOSTOMY CARE TRAY
K
93
3412
SALINE SOLUTION-STERILE
K
93
1611
PERCUTANEOUS TRACHEOSTOMY TUBE KIT
K
92
5288
TRACHEOSTOMY KIT
K
92
3156
TRACHEOSTOMY CARE TRAY
K
92
5020
TRACHEOSTOMY CARE KIT (STERILE)
K
93
0895
SHILEY FENESTRATED REUSABLE INNER CANNULA, MODIF
K
92
4243
TRACHEOSTOMY CARE KIT
K
92
5438
COMBINATION TRACH TIE & VENTILATOR ANTIDISCONNECT
K
92
2665
BIVONA HYPERFLEX TRACHEOSTOMY TUBE
K
92
3878
BIVONA CUSTOMIZED TRACHEOSTOMY TUBES
K
92
4660
TRACHEOSTOMY TUBE AND TUBE CUFF
K
91
4471
NEEDLECRIC
K
91
3859
BIVONA FOME-CUF(R) & AIR CUF(R), MODIFICATION
K
91
4183
BIVONA CUFF MAINTENANCE DEVICE (CMD)
K
91
4088
BIVONA AIRE-CUF(R) PEDIATRIC TRACHEOSTOMY TUBE
K
91
3270
BIVONA FOME-CUF(R) PEDIATRIC TRACHEOSTOMY TUBE
K
91
2967
BIVONA AIRE-CUF TRACHEOSTOMY TUBE W/TALK ATTACH.
K
91
1080
HYGIENA-TRACH
K
91
0362
TRACHEOSTOMY CARE KIT
K
90
3435
SHILEY SPECIALIZED TRACHEOSTOMY TUBE
K
90
3699
PASSY-MUIR TRACHEOSTOMY SPEAKING VALVE 15MM / 22MM
K
89
7102
HYDRASORB(TM)
K
89
7005
BLOM-SINGER(R) SILICONE LARYNGECTOMY TUBE
K
89
7059
HOOD SPEAKING VALVE
K
89
6547
MODIFIED FOME-CUF SILICONE TRACHEOSTOMY TUBE
K
89
6548
MODIFIED AIRE-CUF SILICONE TRACHEOSTOMY TUBE
K
89
4614
BIVONA AIRE-CUF ADJUSTABLE TRACHEOSTOMY TUBE
K
89
4613
BIVONA FOME-CUF ADJUSTABLE TRACHEOSTOMY TUBE
K
89
4050
MODIFIED DECANNULATION STOPPER
K
89
0194
SHILEY SPECIALIZED TRACHEOSTOMY TUBE
K
88
5129
MODIFIED FOME-CUF SILICONE TRACHEOSTOMY TUBE
K
88
5130
MODIFIED AIRE-CUF SILICONE TRACHEOSTOMY TUBE
K
81
2163
AIRE-CUF TRACHEOSTOMY TUBE
K
81
2302
SHILEY FENESTRATED LOW PRESS. CUFFED
K
76
0453
REGULATOR, PRESSURE, CUFF
KFZ
Humidifier, Non-Direct Patient Interface (Home-Use)
KGB
Mask, Oxygen, Non-Rebreathing
KHA
Mask, Scavenging
LNZ
Changer, Tube, Endotracheal
MIA
Needle, Spinal, Short Term
MNS
Ventilator, Continuous, Non-Life-Supporting
MNT
Ventilator, Continuous, Minimal Ventilatory Support, Facility Use
MRN
Apparatus, Nitric Oxide Delivery
MRO
Apparatus, Nitric Oxide, Backup Delivery
MZT
Device, Heimlich Maneuver Assist
NFB
Conserver, Oxygen
NHJ
Device, Positive Pressure Breathing, Intermittent
NHK
Resuscitator, Manual, Non Self-Inflating
NMA
Tube, Tracheal, Reprocessed
NMC
Mask, Ventilator, Non-Continuous, Reprocessed
NMR
Needle, Spinal, Short Term, Reprocessed
NNH
Needle, Conduction, Anesthesia, Reprocessed
NOU
Continuous, Ventilator, Home Use
NQY
Ventilator, Continuous, Minimal Ventilatory Support, Home Use
NVO
Spacer, Direct Patient Interface
NVP
Holding Chambers, Direct Patient Interface
NXA
Tracheotomy Care Kit
OBN
Humidifier, Respiratory, Mask (Direct Patient Interface)
OFQ
Anesthesia Kit
OFT
Spinal Epidural Anesthesia Kit
OFU
Spinal Anesthesia Kit
OFV
Regional Anesthesia Kit
OGA
Brachial Plexus Anesthesia Kit
OGB
Caudal Anesthesia Kit
OGC
Continuous Brachial Plexus Block Tray
OGD
Custom Anesthesia Tray
OGE
Epidural Anesthesia Kit
OGF
Glossopharyngeal Anesthesia Kit
OGG
Humidifier Nebulizer Kit
OGH
Laryngoscope Kit
OGI
Nasal Endotracheal Tube Holder Kit
OGJ
Nerve Block Tray
OGL
Oxygen Administration Kit
OLF
Medevac Use Oxygen Generator
ONZ
Mechanical Ventilator
OQU
Airway Monitoring System
PHS
Oral Airway Assist
PMB
External Airway
QAV
High Flow/High Velocity Humidified Oxygen Delivery Device
QBY
Positive Airway Pressure System
QCX
Retrograde Intubation Set
OZR
Intraoral Pressure Gradient Device
QFB
Isocapnic Ventilation Device
Subpart G—Miscellaneous
Cardiovascular
Chemistry
Dental
Ear, Nose, Throat
Gastroenterology and Urology
General Hospital
Hematology
Immunology
Microbiology
Neurology
Obstetrical and Gynecological
Ophthalmic
Orthopedic
Pathology
Physical Medicine
Radiology
General and Plastic Surgery
Toxicology
Medical Genetics
Unknown
AN
/
subpart-f—therapeutic-devices
/
JOH
/
K944178
View Source
BIVONA FLEXTEND PEDIATRIC & NEONATAL TRACHEOSTROMY TUBES
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K944178
510(k) Type
Traditional
Applicant
BIVONA MEDICAL TECHNOLOGIES
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
10/27/1994
Days to Decision
62 days
Submission Type
Summary