---
kind: "section"
citation: "21 C.F.R. § 880.5130"
title: "21"
number: "880.5130"
heading: "Infant radiant warmer."
url: "https://uscodex.org/cfr/21/880.5130"
---

# §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](/cfr/21/801.109.md) 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.

## Notes

### Amendments

[62 FR 33350, June 19, 1997]

### Authority

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.

### Source

Source: 45 FR 69682, Oct. 21, 1980, unless otherwise noted.

### Amendments

[62 FR 33350, June 19, 1997]