ONM · Radiant Infant Warmer Cabinet
General Hospital · 21 CFR 880.5130 · Class 2
Overview
| Product Code | ONM |
|---|---|
| Device Name | Radiant Infant Warmer Cabinet |
| Regulation | 21 CFR 880.5130 |
| Device Class | Class 2 |
| Review Panel | General Hospital |
| 3rd-Party Reviewable | Yes |
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.
Classification Rationale
Class II (Special Controls)
Special Controls
*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.
Recent Cleared Devices (0 of 0)
No cleared devices on record.
