Part 880 Subpart G—General Hospital and Personal Use Miscellaneous Devices
FDA submissions for Part 880 Subpart G—General Hospital and Personal Use Miscellaneous Devices in the General Hospital (HO) review panel, including product codes and regulations.
Section range: §§ 880.6025–880.6994
CFR Part: 880
Product Codes
| Product Code | Device Name | Regulation | Class | Devices |
|---|---|---|---|---|
| KXF | Applicator, Absorbent Tipped, Non-Sterile | 880.6025 | 1 | 21 |
| KXG | Applicator, Absorbent Tipped, Sterile | 880.6025 | 1 | 1 |
| KYR | Bag, Ice | 880.6050 | 1 | 4 |
| KME | Bedding, Disposable, Medical | 880.6060 | 1 | 65 |
| FPS | Board, Bed | 880.6070 | 1 | 1 |
| FOA | Board, Cardiopulmonary | 880.6080 | 1 | 3 |
| FPF | Bottle, Hot/Cold Water | 880.6085 | 1 | 1 |
| FLI | Cabinet, Ethylene-Oxide Gas Aerator | 880.6100 | 2 | 8 |
| FML | Chair, Blood Donor | 880.6140 | 1 | 2 |
| FRJ | Chair, Geriatric | 880.6140 | 1 | 0 |
| FRK | Chair, Examination And Treatment | 880.6140 | 1 | 4 |
| KMN | Chair And Table, Medical | 880.6140 | 1 | 3 |
| FLG | Cleaner, Ultrasonic, Medical Instrument | 880.6150 | 1 | 19 |
| KIA | Cover, Cast | 880.6185 | 1 | 1 |
| FMW | Cover, Mattress (Medical Purposes) | 880.6190 | 1 | 14 |
| QTV | Mattress And Bed Deck Cover (Medical Purposes) | 880.6190 | 1 | 1 |
| FNS | Ring Cutter | 880.6200 | 1 | 0 |
| MTV | Sharps Needle Destruction Device | 880.6210 | 2 | 9 |
| FMA | Depressor, Tongue, Non-Surgical | 880.6230 | 1 | 5 |
| FMC | Patient Examination Glove | 880.6250 | 1 | 34 |
| LYY | Latex Patient Examination Glove | 880.6250 | 1 | 1954 |
| LYZ | Vinyl Patient Examination Glove | 880.6250 | 1 | 799 |
| LZA | Polymer Patient Examination Glove | 880.6250 | 1 | 1168 |
| LZB | Finger Cot | 880.6250 | 1 | 5 |
| LZC | Medical Glove, Specialty | 880.6250 | 1 | 79 |
| OIG | Powder-Free Guayle Rubber Examination Glove | 880.6250 | 1 | 1 |
| OPC | Powder-Free Polychloroprene Patient Examination Glove | 880.6250 | 1 | 1 |
| OPH | Radiation Attenuating Medical Glove | 880.6250 | 1 | 0 |
| OPJ | Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs | 880.6250 | 1 | 0 |
| PWP | Blood Borne Pathogen Response Kit | 880.6250 | 1 | 0 |
| PWS | Chemotherapy Administration Kit | 880.6250 | 1 | 0 |
| PWT | Chemotherapy Spill Clean-Up Kit | 880.6250 | 1 | 0 |
| PWV | Delivery Room Apparel Kit | 880.6250 | 1 | 0 |
| PXC | Personal Protection Kit | 880.6250 | 1 | 0 |
| PXD | Prep Kit | 880.6250 | 1 | 0 |
| QDO | Fentanyl And Other Opioid Protection Glove | 880.6250 | 1 | 0 |
| NZJ | Respirator, N95, For Use By The General Public In Public Health Medical Emergencies | 880.6260 | 2 | 2 |
| ORW | N95 Respirator With Antimicrobial/Antiviral Agent For Use By The General Public In Public Health Medical Emergencies | 880.6260 | 2 | 1 |
| FME | Gown, Examination | 880.6265 | 1 | 5 |
| KYS | Insoles, Medical | 880.6280 | 1 | 1 |
| NRV | Implantable Radio Frequency Transponder System | 880.6300 | 2 | 1 |
| PYQ | Rfid Chip For Dental Appliance | 880.6300 | 2 | 1 |
| OZW | Ingestible Event Marker | 880.6305 | 2 | 8 |
| OUG | Medical Device Data System | 880.6310 | 1 | 1 |
| NZH | Medication Management System, Remote | 880.6315 | 2 | 2 |
| SAK | Software Device To Aid In The Prediction Or Diagnosis Of Sepsis | 880.6316 | 2 | 1 |
| KZF | Device, Medical Examination, Ac Powered | 880.6320 | 1 | 37 |
| PEQ | Accessories To Examination Light | 880.6320 | 1 | 1 |
| KYT | Light, Examination, Medical, Battery Powered | 880.6350 | 1 | 6 |
| KMJ | Lubricant, Patient | 880.6375 | 1 | 49 |
| MMS | Lubricant, Vaginal, Patient | 880.6375 | 1 | 0 |
| ONK | Oral Lubricant | 880.6375 | 1 | 1 |
| KYW | Container, Liquid Medication, Graduated | 880.6430 | 1 | 2 |
| KYX | Dispenser, Liquid Medication | 880.6430 | 1 | 11 |
| OHY | Pill Crusher/Cutter | 880.6430 | 1 | 0 |
| PXA | Oral Administration Set | 880.6430 | 1 | 0 |
| FMP | Protector, Skin Pressure | 880.6450 | 1 | 23 |
| FRA | Purifier, Air, Ultraviolet, Medical | 880.6500 | 2 | 36 |
| MKB | Device, Germicidal, Ultraviolet | 880.6500 | 2 | 0 |
| QXJ | Whole Room Microbial Reduction Device | 880.6510 | 2 | 2 |
| SCS | Ultraviolet Radiation Disinfection Chamber Device | 880.6511 | 2 | 2 |
| SGX | Ultraviolet Light-Based Microbial Reduction Device For Luer-Activated Valves | 880.6512 | 2 | 1 |
| OSZ | Antimicrobial Keyboard | 880.6600 | 2 | 1 |
| KMG | Purifier, Water, Ultraviolet, Medical | 880.6710 | 2 | 9 |
| FNP | Urinal | 880.6730 | 1 | 1 |
| FNY | Basin, Emesis | 880.6730 | 1 | 9 |
| FOB | Bedpan | 880.6730 | 1 | 5 |
| PWM | Admission Kit (Patient Utensil) | 880.6730 | 1 | 0 |
| PWZ | Mid-Stream Collection Kit | 880.6730 | 1 | 0 |
| PXF | Sitz Bath Kit | 880.6730 | 1 | 0 |
| BYY | Tube, Aspirating, Flexible, Connecting | 880.6740 | 2 | 24 |
| BYZ | Trap, Sterile Specimen | 880.6740 | 2 | 9 |
| CBC | Bottle, Collection And Trap, Breathing System (Uncalibrated) | 880.6740 | 2 | 3 |
| CBD | Bottle, Collection, Breathing System (Calibrated) | 880.6740 | 2 | 3 |
| GAZ | Tubing, Noninvasive | 880.6740 | 2 | 27 |
| GCX | Apparatus, Suction, Operating-Room, Wall Vacuum Powered | 880.6740 | 2 | 87 |
| JOL | Catheter And Tip, Suction | 880.6740 | 2 | 84 |
| KDP | Regulator, Vacuum | 880.6740 | 2 | 21 |
| KDQ | Bottle, Collection, Vacuum | 880.6740 | 2 | 48 |
| PAD | Chest Drainage Kit | 880.6740 | 2 | 0 |
| BRT | Restraint, Patient, Conductive | 880.6760 | 1 | 0 |
| FMQ | Restraint, Protective | 880.6760 | 1 | 134 |
| OYS | Patient Bed With Canopy/Restraints | 880.6760 | 1 | 3 |
| FRZ | Device, Patient Transfer, Powered | 880.6775 | 2 | 5 |
| FMR | Device, Transfer, Patient, Manual | 880.6785 | 1 | 5 |
| FLH | Washer Of Body Waste Receptacles | 880.6800 | 1 | 0 |
| JOK | Scissors, Medical, Disposable | 880.6820 | 1 | 7 |
| FRG | Wrap, Sterilization | 880.6850 | 2 | 320 |
| KCT | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | 880.6850 | 2 | 277 |
| QJT | Rigid Sterilization Container With Software | 880.6855 | 2 | 1 |
| FLF | Sterilizer, Ethylene-Oxide Gas | 880.6860 | 2 | 26 |
| MLR | Sterilizer, Chemical | 880.6860 | 2 | 47 |
| PJJ | Two Or More Sterilant Sterilizer | 880.6860 | 2 | 6 |
| KMH | Sterilizer, Dry Heat | 880.6870 | 2 | 10 |
| FLE | Sterilizer, Steam | 880.6880 | 2 | 184 |
| PEC | Sterilizer Automated Loading System | 880.6880 | 2 | 1 |
| LFE | Solution, Cold Sterilizing | 880.6885 | 2 | 1 |
| MED | Sterilant, Medical Devices | 880.6885 | 2 | 64 |
| QWS | Foam Or Gel Chemical Sterilant/High Level Disinfectant | 880.6886 | 2 | 2 |
| OVY | Liquid Chemical Processing System | 880.6887 | 2 | 4 |
| LRJ | Disinfectant, Medical Devices | 880.6890 | 1 | 73 |
| PWU | Clean-Up Kit | 880.6890 | 1 | 0 |
| PXG | Spill Kit | 880.6890 | 1 | 0 |
| PXM | Vomitus Clean-Up Kit | 880.6890 | 1 | 0 |
| FPP | Stretcher, Hand-Carried | 880.6900 | 1 | 39 |
| NZD | Stretcher, Patient Restraint | 880.6900 | 1 | 1 |
| FPO | Stretcher, Wheeled | 880.6910 | 2 | 50 |
| KZH | Introducer, Syringe Needle | 880.6920 | 2 | 47 |
| SDC | Qualitative Cleaning Process Protein Indicator | 880.6930 | 2 | 1 |
| KYZ | Syringe, Irrigating (Non Dental) | 880.6960 | 1 | 41 |
| OGQ | Ear Irrigation Kit | 880.6960 | 1 | 0 |
| KZA | Device, Vein Location, Liquid Crystal | 880.6970 | 1 | 6 |
| LBJ | Device, Vein Stabilization | 880.6980 | 1 | 0 |
| FOX | Stand, Infusion | 880.6990 | 1 | 36 |
| LDS | Device, Pasteurization, Hot Water | 880.6991 | 2 | 11 |
| MDZ | Cleaners, Medical Devices | 880.6992 | 2 | 2 |
| MEC | Disinfector, Medical Devices | 880.6992 | 2 | 2 |
| QXQ | Respiratory Accessory Microbial Reduction Device. | 880.6993 | 2 | 2 |
| SEW | Automated Endoscope Channel Cleaner | 880.6994 | 2 | 2 |
