[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR880.5130]

[Page 387]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 880--GENERAL HOSPITAL AND PERSONAL USE DEVICES--Table of Contents
 
    Subpart F--General Hospital and Personal Use Therapeutic Devices
 
Sec. 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 Sec. 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]

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