Identity
- Trade Name
- HEATER FDA UDI
- Generic Name
- Infant warmer FDA UDI
- Device Name
- Heating Element Only FDA UDI
- Model / Reference
- OMH005 FDA UDI
- Description
- Heating Element Only FDA UDI
Identifiers
- Catalog Number
- OMH005 FDA UDI
- Primary DI / UDI-DI
- 00841034117209 FDA UDI
- FDA Product Code
- FMT FDA UDI
- GMDN Term
- Infant warmer FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5130 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Infant warmer
Heater by Rpi — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Infant warmer.
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- NuBorne Infant Warmer — INTERNATIONAL BIOMEDICAL, LTD. · Class II
- Olympic Warm-Lamps — Natus Medical Incorporated · Class II
- Panda — Datex-Ohmeda Inc. · Class II
- Panda — Datex-Ohmeda Inc. · Class II
- Olympic Warm-Lamps — Natus Medical Incorporated · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Rpi
Sources (1)
- FDA UDI f50eb024-3ee2-4583-8479-c23bb78a53f3 35 fields · synced May 30, 2026