21 CFR Part 880
PART 880—GENERAL HOSPITAL AND PERSONAL USE DEVICES
- PART 880—GENERAL HOSPITAL AND PERSONAL USE DEVICES
- Chapter I—Food and Drug Administration, Department of Health and Human Services › Subchapter H—Medical 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 [Reserved]
- 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 [Reserved]
- 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.
- § 880.5220 Intravenous catheter force-activated separation device.
- § 880.5240 Medical adhesive tape and adhesive bandage.
- § 880.5270 Neonatal eye pad.
- § 880.5300 Medical absorbent fiber.
- § 880.5400 Neonatal incubator.
- § 880.5405 Active noise attenuation system for infant incubators.
- § 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.
- § 880.5690 Infant supine sleep system.
- § 880.5700 Neonatal phototherapy unit.
- § 880.5725 Infusion pump.
- § 880.5730 Alternate controller enabled infusion pump.
- § 880.5735 Diabetes digital behavioral therapeutic device.
- § 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 Sharps needle destruction device.
- § 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.
- § 880.6855 Rigid sterilization container with electronic monitoring.
- § 880.6860 Ethylene oxide gas sterilizer.
- § 880.6870 Dry-heat sterilizer.
- § 880.6880 Steam sterilizer.
- § 880.6885 Liquid chemical sterilants/high level disinfectants.
- § 880.6886 Foam or gel chemical sterilant/high level disinfectant.
- § 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.
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