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Code of Federal Regulations (Last Updated: April 5, 2024) |
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Title 21 - Food and Drugs |
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Chapter I - Food and Drug Administration, Department of Health and Human Services |
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SubChapter H - Medical Devices |
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Part 880 - General Hospital and Personal Use Devices |
| Subpart A - General Provisions |
| § 880.1 - Scope. |
| § 880.3 - Effective dates of requirement for premarket approval. |
| § 880.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act). |
| Subpart B - XXX |
| Subpart C - General Hospital and Personal Use Monitoring Devices |
| § 880.2200 - Liquid crystal forehead temperature strip. |
| § 880.2400 - Bed-patient monitor. |
| § 880.2420 - Electronic monitor for gravity flow infusion systems. |
| § 880.2460 - Electrically powered spinal fluid pressure monitor. |
| § 880.2500 - Spinal fluid manometer. |
| § 880.2700 - Stand-on patient scale. |
| § 880.2720 - Patient scale. |
| § 880.2740 - Surgical sponge scale. |
| § 880.2750 - Image processing device for estimation of external blood loss. |
| § 880.2800 - Sterilization process indicator. |
| § 880.2900 - Clinical color change thermometer. |
| § 880.2910 - Clinical electronic thermometer. |
| § 880.2920 - Clinical mercury thermometer. |
| § 880.2930 - Apgar timer. |
| Subparts D--E - XXX |
| Subpart F - General Hospital and Personal Use Therapeutic Devices |
| § 880.5025 - I.V. container. |
| § 880.5045 - Medical recirculating air cleaner. |
| § 880.5075 - Elastic bandage. |
| § 880.5090 - Liquid bandage. |
| § 880.5100 - AC-powered adjustable hospital bed. |
| § 880.5110 - Hydraulic adjustable hospital bed. |
| § 880.5120 - Manual adjustable hospital bed. |
| § 880.5130 - Infant radiant warmer. |
| § 880.5140 - Pediatric medical crib. |
| § 880.5145 - Medical bassinet. |
| § 880.5150 - Nonpowered flotation therapy mattress. |
| § 880.5160 - Therapeutic medical binder. |
| § 880.5180 - Burn sheet. |
| § 880.5200 - Intravascular catheter. |
| § 880.5210 - Intravascular catheter securement device. |
| § 880.5240 - Medical adhesive tape and adhesive bandage. |
| § 880.5270 - Neonatal eye pad. |
| § 880.5300 - Medical absorbent fiber. |
| § 880.5400 - Neonatal incubator. |
| § 880.5410 - Neonatal transport incubator. |
| § 880.5420 - Pressure infusor for an I.V. bag. |
| § 880.5430 - Nonelectrically powered fluid injector. |
| § 880.5440 - Intravascular administration set. |
| § 880.5445 - Intravascular administration set, automated air removal system. |
| § 880.5450 - Patient care reverse isolation chamber. |
| § 880.5475 - Jet lavage. |
| § 880.5500 - AC-powered patient lift. |
| § 880.5510 - Non-AC-powered patient lift. |
| § 880.5550 - Alternating pressure air flotation mattress. |
| § 880.5560 - Temperature regulated water mattress. |
| § 880.5570 - Hypodermic single lumen needle. |
| § 880.5580 - Acupuncture needle. |
| § 880.5630 - Nipple shield. |
| § 880.5640 - Lamb feeding nipple. |
| § 880.5680 - Pediatric position holder. |
| § 880.5700 - Neonatal phototherapy unit. |
| § 880.5725 - Infusion pump. |
| § 880.5730 - Alternate controller enabled infusion pump. |
| § 880.5740 - Suction snakebite kit. |
| § 880.5760 - Chemical cold pack snakebite kit. |
| § 880.5780 - Medical support stocking. |
| § 880.5820 - Therapeutic scrotal support. |
| § 880.5860 - Piston syringe. |
| § 880.5950 - Umbilical occlusion device. |
| § 880.5960 - Lice removal kit. |
| § 880.5965 - Subcutaneous, implanted, intravascular infusion port and catheter. |
| § 880.5970 - Percutaneous, implanted, long-term intravascular catheter. |
| Subpart G - General Hospital and Personal Use Miscellaneous Devices |
| § 880.6025 - Absorbent tipped applicator. |
| § 880.6050 - Ice bag. |
| § 880.6060 - Medical disposable bedding. |
| § 880.6070 - Bed board. |
| § 880.6080 - Cardiopulmonary resuscitation board. |
| § 880.6085 - Hot/cold water bottle. |
| § 880.6100 - Ethylene oxide gas aerator cabinet. |
| § 880.6140 - Medical chair and table. |
| § 880.6150 - Ultrasonic cleaner for medical instruments. |
| § 880.6175 - [Reserved] |
| § 880.6185 - Cast cover. |
| § 880.6190 - Mattress cover for medical purposes. |
| § 880.6200 - Ring cutter. |
| § 880.6210 - xxx |
| § 880.6230 - Tongue depressor. |
| § 880.6250 - Non-powdered patient examination glove. |
| § 880.6260 - Filtering facepiece respirator for use by the general public in public health medical emergencies. |
| § 880.6265 - Examination gown. |
| § 880.6280 - Medical insole. |
| § 880.6300 - Implantable radiofrequency transponder system for patient identification and health information. |
| § 880.6305 - Ingestible event marker. |
| § 880.6310 - Medical device data system. |
| § 880.6315 - Remote Medication Management System. |
| § 880.6320 - AC-powered medical examination light. |
| § 880.6350 - Battery-powered medical examination light. |
| § 880.6375 - Patient lubricant. |
| § 880.6430 - Liquid medication dispenser. |
| § 880.6450 - Skin pressure protectors. |
| § 880.6500 - Medical ultraviolet air purifier. |
| § 880.6600 - Ultraviolet (UV) radiation chamber disinfection device. |
| § 880.6710 - Medical ultraviolet water purifier. |
| § 880.6730 - Body waste receptacle. |
| § 880.6740 - Vacuum-powered body fluid suction apparatus. |
| § 880.6760 - Protective restraint. |
| § 880.6775 - Powered patient transfer device. |
| § 880.6785 - Manual patient transfer device. |
| § 880.6800 - Washers for body waste receptacles. |
| § 880.6820 - Medical disposable scissors. |
| § 880.6850 - Sterilization wrap. |
| § 880.6860 - Ethylene oxide gas sterilizer. |
| § 880.6870 - Dry-heat sterilizer. |
| § 880.6880 - Steam sterilizer. |
| § 880.6885 - Liquid chemical sterilants/high level disinfectants. |
| § 880.6887 - Spore test strip. |
| § 880.6890 - General purpose disinfectants. |
| § 880.6900 - Hand-carried stretcher. |
| § 880.6910 - Wheeled stretcher. |
| § 880.6920 - Syringe needle introducer. |
| § 880.6960 - Irrigating syringe. |
| § 880.6970 - Liquid crystal vein locator. |
| § 880.6980 - Vein stabilizer. |
| § 880.6990 - Infusion stand. |
| § 880.6991 - Medical washer. |
| § 880.6992 - Medical washer-disinfector. |