FDA product code ONM

Radiant Infant Warmer Cabinet

General Hospital·Class 2·21 CFR 880.5130
US regulatory classifications
US Product Code (FDA)
ONM
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US Risk Class (FDA)
Class 2
US Regulation (CFR)
21 CFR 880.5130
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Medical specialty
General Hospital
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
No
Third party review
Eligible
Definition

The device is intended to provide an enclosure for storage of an radiant infant warmer. It may also provide a bassinet for use with the radiant infant warmer, and provide power to the infant radiant warmer.

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About this record

Radiant Infant Warmer Cabinet is a medical device type in the General Hospital specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.