Part 880 Subpart F—General Hospital and Personal Use Therapeutic Devices
FDA submissions for Part 880 Subpart F—General Hospital and Personal Use Therapeutic Devices in the General Hospital (HO) review panel, including product codes and regulations.
Section range: §§ 880.5025–880.5970
CFR Part: 880
Product Codes
| Product Code | Device Name | Regulation | Class | Devices |
|---|---|---|---|---|
| KPE | Container, I.V. | 880.5025 | 2 | 117 |
| FRF | Cleaner, Air, Medical Recirculating | 880.5045 | 2 | 53 |
| NUP | Cream, Nasal, Topical, Mechanical Allergen Particle Barrier | 880.5045 | 2 | 8 |
| FQM | Bandage, Elastic | 880.5075 | 1 | 42 |
| MCY | Wound Dressing Kit | 880.5075 | 2 | 24 |
| MHW | Dressing, Compression | 880.5075 | 1 | 2 |
| OXQ | Dressing Change Tray | 880.5075 | 1 | 0 |
| KMF | Bandage, Liquid | 880.5090 | 1 | 222 |
| NEC | Bandage, Liquid, Skin Protectant | 880.5090 | 1 | 3 |
| FNL | Bed, Ac-Powered Adjustable Hospital | 880.5100 | 2 | 70 |
| LLI | Bed, Therapeutic, Ac-Powered, Adjustable Home-Use | 880.5100 | 2 | 2 |
| OSI | Bariatric Bed | 880.5100 | 2 | 0 |
| FNK | Bed, Hydraulic, Adjustable Hospital | 880.5110 | 1 | 1 |
| FNJ | Bed, Manual | 880.5120 | 1 | 39 |
| FMT | Warmer, Infant Radiant | 880.5130 | 2 | 92 |
| ONM | Radiant Infant Warmer Cabinet | 880.5130 | 2 | 0 |
| FMS | Bed, Pediatric Open Hospital | 880.5140 | 2 | 27 |
| NZG | Bassinet, Hospital | 880.5145 | 2 | 0 |
| IKY | Mattress, Flotation Therapy, Non-Powered | 880.5150 | 1 | 8 |
| QVY | Therapeutic Vibrational Mattress Pad, Adjunct Use In Neonatal Abstinence Syndrome Or Neonatal Opioid Withdrawal Syndrome | 880.5151 | 2 | 1 |
| FQK | Binder, Perineal | 880.5160 | 1 | 0 |
| FSD | Binder, Abdominal | 880.5160 | 1 | 5 |
| HEF | Binder, Breast | 880.5160 | 1 | 0 |
| KMO | Binder, Elastic | 880.5160 | 1 | 5 |
| MDR | Binder, Medical, Therapeutic | 880.5160 | 1 | 0 |
| FPY | Sheet, Burn | 880.5180 | 1 | 17 |
| FOS | Catheter, Umbilical Artery | 880.5200 | 2 | 34 |
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | 880.5200 | 2 | 503 |
| LRS | I.V. Start Kit | 880.5200 | 2 | 30 |
| NGT | Saline, Vascular Access Flush | 880.5200 | 2 | 41 |
| NZW | Heparin, Vascular Access Flush | 880.5200 | 2 | 7 |
| NZX | Water, Vascular Access Flush | 880.5200 | 2 | 0 |
| OWL | Peripheral Catheter Insertion Kit | 880.5200 | 2 | 0 |
| PEF | Heparin Flush In 0.45% Sodium Chloride | 880.5200 | 2 | 0 |
| PEZ | Central Venous Catheter Dressing Change Kit | 880.5200 | 2 | 0 |
| PND | Midline Catheter | 880.5200 | 2 | 13 |
| PXJ | Umbilical Catheter Insertion Tray | 880.5200 | 2 | 0 |
| QTI | Saline Vascular Access Flush With Integrated Alcohol Disinfectant Device | 880.5200 | 2 | 1 |
| SEF | Central Venous Catheter With Manual Insertion System | 880.5200 | 2 | 1 |
| KMK | Device, Intravascular Catheter Securement | 880.5210 | 1 | 64 |
| PUK | Administration Set Securement Device | 880.5210 | 1 | 0 |
| QOI | Intravenous Catheter Force-Activated Separation Device. | 880.5220 | 2 | 8 |
| FPX | Strip, Adhesive, Closure, Skin | 880.5240 | 1 | 35 |
| KGX | Tape And Bandage, Adhesive | 880.5240 | 1 | 187 |
| MZR | Topical Approximation System | 880.5240 | 1 | 0 |
| PYO | Tape And Bandage, Adhesive, Adjustable Closing Mechanism, Otc Use | 880.5240 | 1 | 1 |
| FOK | Pad, Neonatal Eye | 880.5270 | 1 | 5 |
| FRL | Fiber, Medical, Absorbent | 880.5300 | 1 | 19 |
| FMZ | Incubator, Neonatal | 880.5400 | 2 | 85 |
| QWX | Active Noise Attenuation System For Infant Incubators | 880.5405 | 2 | 1 |
| FPL | Incubator, Neonatal Transport | 880.5410 | 2 | 25 |
| KZD | Infusor, Pressure, For I.V. Bags | 880.5420 | 1 | 35 |
| KZE | Injector, Fluid, Non-Electrically Powered | 880.5430 | 2 | 53 |
| BRZ | Set, Blood Transfusion | 880.5440 | 2 | 30 |
| CAK | Microfilter, Blood Transfusion | 880.5440 | 2 | 36 |
| FMG | Stopcock, I.V. Set | 880.5440 | 2 | 89 |
| FPA | Set, Administration, Intravascular | 880.5440 | 2 | 1174 |
| FPB | Filter, Infusion Line | 880.5440 | 2 | 98 |
| FPK | Tubing, Fluid Delivery | 880.5440 | 2 | 64 |
| LHI | Set, I.V. Fluid Transfer | 880.5440 | 2 | 205 |
| MJF | Check Valve, Retrograde Flow (In-Line) | 880.5440 | 2 | 1 |
| NEP | System/Device, Pharmacy Compounding | 880.5440 | 2 | 0 |
| ODI | Administration Set Docking Station | 880.5440 | 2 | 1 |
| OJA | Intravenous Extension Tubing Set | 880.5440 | 2 | 1 |
| ONB | Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System | 880.5440 | 2 | 41 |
| POQ | Blood Transfusion Kit | 880.5440 | 2 | 0 |
| POR | Parenteral Administration Kit | 880.5440 | 2 | 0 |
| PQH | Iodinated Contrast Media Transfer Tubing Set | 880.5440 | 2 | 5 |
| PWH | Administrations Sets With Neuraxial Connectors | 880.5440 | 2 | 4 |
| PWO | Blood Administration Kit | 880.5440 | 2 | 0 |
| PWQ | Buret Administration Intravenous Kit | 880.5440 | 2 | 0 |
| PYR | Neuraxial Administration Set - Intrathecal Delivery | 880.5440 | 2 | 0 |
| QBP | Cap, Device Disinfectant | 880.5440 | 2 | 22 |
| OKL | Intravascular Administration Set, Automated Air Removal System | 880.5445 | 2 | 2 |
| FRR | Chamber, Reverse Isolation, Patient Care | 880.5450 | 2 | 1 |
| LGM | Chamber, Patient Isolation | 880.5450 | 2 | 12 |
| LGN | Chamber, Patient Transport Isolation | 880.5450 | 2 | 2 |
| FQH | Lavage, Jet | 880.5475 | 2 | 53 |
| FNG | Lift, Patient, Ac-Powered | 880.5500 | 2 | 21 |
| FSA | Lift, Patient, Non-Ac-Powered | 880.5510 | 1 | 13 |
| FNM | Mattress, Air Flotation, Alternating Pressure | 880.5550 | 2 | 102 |
| FOH | Mattress, Water, Temperature Regulated | 880.5560 | 1 | 6 |
| FMI | Needle, Hypodermic, Single Lumen | 880.5570 | 2 | 689 |
| MHC | Needle, Interosseous | 880.5570 | 2 | 2 |
| MMK | Container, Sharps | 880.5570 | 2 | 112 |
| NKK | Needle, Hypodermic, Single Lumen, Reprocessed | 880.5570 | 2 | 0 |
| PTI | Non-Coring (Huber) Needle | 880.5570 | 2 | 13 |
| PVZ | Non-Stainless Steel Needle | 880.5570 | 2 | 1 |
| PWY | Lumbar Puncture Tray (Adult & Pediatric) | 880.5570 | 2 | 0 |
| PXB | Percutaneous Introducer Kit | 880.5570 | 2 | 0 |
| PXI | Thoracentesis Tray | 880.5570 | 2 | 0 |
| PXL | Venipuncture Kit | 880.5570 | 2 | 0 |
| QMT | Prep Kit Vaccine Injection | 880.5570 | 2 | 0 |
| QNS | Low Dead Space Needle, Single Lumen, Hypodermic | 880.5570 | 2 | 3 |
| QYM | Ophthalmic Needle | 880.5570 | 2 | 2 |
| SCL | Allergen And Vaccine Delivery Needles | 880.5570 | 2 | 25 |
| BWJ | Locator, Acupuncture Point | 880.5580 | 2 | 3 |
| MQX | Needle, Acupuncture, Single Use | 880.5580 | 2 | 91 |
| NRW | Stimulator, Intramuscular, Automatic | 880.5580 | 2 | 1 |
| HFS | Shield, Nipple | 880.5630 | 1 | 12 |
| NTC | Nursing Pad, Hydrogel | 880.5630 | 1 | 1 |
| NTX | Nursing Pad, Polyurethane Pad With Starch Copolymer, Glycerin, And Surfactant (F-68) | 880.5630 | 1 | 1 |
| NXH | Nursing Pad, Cohesive Gel | 880.5630 | 1 | 1 |
| FNN | Nipple, Lambs Feeding | 880.5640 | 1 | 0 |
| FRP | Holder, Infant Position | 880.5680 | 1 | 14 |
| OUW | Infant Positioner, Rx, Use In Highly Monitored Setting | 880.5680 | 1 | 1 |
| PRN | Pediatric Position Holder | 880.5680 | 1 | 0 |
| QTG | Infant Supine Sleep System | 880.5690 | 2 | 1 |
| LBI | Unit, Neonatal Phototherapy | 880.5700 | 2 | 71 |
| PDH | Blanket, Neonatal Phototherapy | 880.5700 | 2 | 2 |
| PWN | Baby Care Kit | 880.5700 | 2 | 0 |
| FRN | Pump, Infusion | 880.5725 | 2 | 848 |
| LDR | Controller, Infusion, Intravascular, Electronic | 880.5725 | 2 | 60 |
| LGZ | Warmer, Thermal, Infusion Fluid | 880.5725 | 2 | 75 |
| LHF | Warmer, Microwave, Infusion Fluid | 880.5725 | 2 | 2 |
| LZF | Pump, Infusion, Analytical Sampling | 880.5725 | 2 | 7 |
| LZG | Pump, Infusion, Insulin | 880.5725 | 2 | 84 |
| LZH | Pump, Infusion, Enteral | 880.5725 | 2 | 34 |
| MEA | Pump, Infusion, Pca | 880.5725 | 2 | 31 |
| MEB | Pump, Infusion, Elastomeric | 880.5725 | 2 | 88 |
| MHD | Pump, Infusion, Gallstone Dissolution | 880.5725 | 2 | 1 |
| MRH | Pump, Infusion, Ophthalmic | 880.5725 | 2 | 19 |
| MRZ | Accessories, Pump, Infusion | 880.5725 | 2 | 48 |
| OPP | Pump, Infusion, Insulin Bolus | 880.5725 | 2 | 7 |
| PHC | Infusion Safety Management Software | 880.5725 | 2 | 10 |
| PKP | Immunoglobulin G (Igg) Infusion System | 880.5725 | 2 | 7 |
| PMS | Peripheral Intravenous (Piv) Infiltration Monitor | 880.5725 | 2 | 5 |
| QJY | Infusion Pump, Drug Specific, Pharmacy-Filled | 880.5725 | 2 | 4 |
| QXC | Diabetes Digital Therapeutic Device | 880.5735 | 2 | 1 |
| KYP | Snake Bite Suction Kit | 880.5740 | 1 | 4 |
| PWX | Insect Sting Emergency Kit | 880.5740 | 1 | 0 |
| KYQ | Kit, Chemical Snake-Bite | 880.5760 | 3 | 0 |
| DWL | Stocking, Medical Support (To Prevent Pooling Of Blood In Legs) | 880.5780 | 2 | 64 |
| FQL | Stocking, Medical Support (For General Medical Purposes) | 880.5780 | 1 | 6 |
| LLK | Legging, Compression, Non-Inflatable | 880.5780 | 2 | 4 |
| FQJ | Support, Scrotal, Therapeutic | 880.5820 | 1 | 0 |
| FMF | Syringe, Piston | 880.5860 | 2 | 749 |
| MEG | Syringe, Antistick | 880.5860 | 2 | 163 |
| MZM | Fibrin Sealant Preparation Device | 880.5860 | 2 | 0 |
| NKN | Syringe, Piston, Reprocessed | 880.5860 | 2 | 0 |
| NSC | Injector, Pen | 880.5860 | 2 | 1 |
| PQX | Epinephrine Syringe | 880.5860 | 2 | 2 |
| PUR | Vacuum Syringe | 880.5860 | 2 | 2 |
| QBL | Piston Syringe Lever | 880.5860 | 2 | 3 |
| QDM | Midazolam Syringe | 880.5860 | 2 | 0 |
| QEH | Piston Syringe With Neuraxial Connector Epidural, Peripheral, And/Or Indirect Cerebral Spinal Fluid Contact | 880.5860 | 2 | 5 |
| QLF | On-Body Injector | 880.5860 | 2 | 0 |
| QLY | Ophthalmic Syringe | 880.5860 | 2 | 7 |
| QNQ | Low Dead Space Piston Syringe | 880.5860 | 2 | 12 |
| QOG | Injection Data Capture Device | 880.5860 | 2 | 7 |
| FOD | Device, Occlusion, Umbilical | 880.5950 | 1 | 0 |
| LJL | Detectors And Removers, Lice, (Including Combs) | 880.5960 | 1 | 11 |
| PUN | Lice Removal Kit Containing A Solution | 880.5960 | 1 | 0 |
| LJT | Port & Catheter, Implanted, Subcutaneous, Intravascular | 880.5965 | 2 | 287 |
| LLD | Port & Catheter, Implanted, Subcutaneous, Intraperitoneal | 880.5965 | 2 | 4 |
| OBK | Port, Protector/Cushion | 880.5965 | 2 | 1 |
| OKE | Port Introducer Kit | 880.5965 | 2 | 0 |
| PTD | Subcutaneous Implanted Apheresis Port | 880.5965 | 2 | 3 |
| PXK | Vascular Access Port Kit | 880.5965 | 2 | 0 |
| LJS | Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days | 880.5970 | 2 | 302 |
| ODY | Tunneled Catheter Remover | 880.5970 | 2 | 2 |
| OKC | Implanted Subcutaneous Securement Catheter | 880.5970 | 2 | 5 |
| OMF | Percutaneous, Implanted, Long-Term Intravascular Catheter Accessory For Catheter Position | 880.5970 | 2 | 2 |
| PWR | Catheter Repair Kit | 880.5970 | 2 | 0 |
| PZW | Catheter Access Cover, Tamper-Resistant | 880.5970 | 2 | 2 |
