Identity
- Trade Name
- modification kit phototherapy FDA UDI
- Generic Name
- Infant warmer FDA UDI
- Model / Reference
- 2M30450 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04048675246312 FDA UDI
- 510(k) Number
- K954611 FDA UDI
- FDA Product Code
- LBI FDA UDI
- GMDN Term
- Infant warmer FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5700 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Category: Infant warmer
modification kit phototherapy by Drägerwerk AG & Co. KGaA — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- HEATER — RPI · Class II
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- Fisher & Paykel Healthcare — FISHER & PAYKEL HEALTHCARE, INC. · Class II
- NuBorne Infant Warmer — INTERNATIONAL BIOMEDICAL, LTD. · 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
- Drägerwerk AG & Co. KGaA
Sources (1)
- FDA UDI 874b1530-2cc7-4791-b999-5d972cdd95d8 34 fields · synced May 30, 2026