21 CFR 880.5130 - Infant radiant warmer.

§ 880.5130 Infant radiant warmer.

(a)Identification. The infant radiant warmer is a device consisting of an infrared heating element intended to be placed over an infant to maintain the infant's body temperature by means of radiant heat. The device may also contain a temperature monitoring sensor, a heat output control mechanism, and an alarm system (infant temperature, manual mode if present, and failure alarms) to alert operators of a temperature condition over or under the set temperature, manual mode time limits, and device component failure, respectively. The device may be placed over a pediatric hospital bed or it may be built into the bed as a complete unit.

(b)Classification. Class II (Special Controls):

(1) The Association for the Advancement of Medical Instrumentation (AAMI) Voluntary Standard for the Infant Radiant Warmer;

(2) A prescription statement in accordance with § 801.109 of this chapter (restricted to use by or upon the order of qualified practitioners as determined by the States); and

(3) Labeling for use only in health care facilities and only by persons with specific training and experience in the use of the device.

[ 62 FR 33350, June 19, 1997]

This is a list of United States Code sections, Statutes at Large, Public Laws, and Presidential Documents, which provide rulemaking authority for this CFR Part.

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United States Code

Title 21 published on 09-Jun-2018 03:51

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR Part 880 after this date.

  • 2018-06-05; vol. 83 # 108 - Tuesday, June 5, 2018
    1. 83 FR 25910 - Medical Devices; Exemptions From Premarket Notification: Class II Devices
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final order.
      This order is effective June 5, 2018.
      21 CFR Parts 862, 866, 876, 880, and 884