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U.S. Department of Health and Human Services

Product Classification

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Device radiant infant warmer cabinet
Regulation Description Infant radiant warmer.
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.
Physical State The accessory could be in a range of sizs and materials. The important aspects are its capability of providing suppport as a bassinet and electrical safety.
Technical Method When not in use, the device encloses the infant radiant warmer. The device opens to provide a bassinet placed under the warmer. The device includes a power outlet that provides power to the warmer and includes a cut-off switch to disconnect power when the accessory device is closed.
Target Area The accessory is intended for use with an infant radiant warmer, which are intended for use in warming the whole body of an infant.
Regulation Medical Specialty General Hospital
Review Panel General Hospital
Product CodeONM
Premarket Review Drug Delivery and General Hospital Devices, and Human Factors (DHT3C)
Drug Delivery and General Hospital Devices, and Human Factors (DHT3C)
Submission Type 510(k)
Regulation Number 880.5130
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review
Accredited Persons