Product Classification

• 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 Code: ONM
• Premarket Review: Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices (OHT3); 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 Reporting: Ineligible
• Implanted Device?: No
• Life-Sustain/Support Device?: No

Third Party Review

• Eligible for 510(k) Third Party Review Program

Accredited Persons

• beanstock consulting
• global quality and regulatory services
• regulatory technology services, llc
• smo india
• third party review group, llc