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e-CFR data is current as of January 21, 2021

Title 21 → Chapter I → Subchapter H → Part 880

TITLE 21—Food and Drugs

CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED)

SUBCHAPTER H—MEDICAL DEVICES

PART 880—GENERAL HOSPITAL AND PERSONAL USE DEVICES

rule

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).
rule

Subpart B—[RESERVED]

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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.
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Subparts D-E [Reserved]

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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.
§880.5740
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.
rule

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.
§880.6860
Ethylene oxide gas sterilizer.
§880.6870
Dry-heat sterilizer.
§880.6880
Steam sterilizer.
§880.6885
Liquid chemical sterilants/high level disinfectants.
§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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