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Babytherm 8004 System
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref 2M22370Model 041382
Identity
- Trade Name
- Babytherm 8004 EUDAMEDBabytherm 8004 System FDA UDI
- Generic Name
- Infant warmer FDA UDI
- Model / Reference
- 2M22370 EUDAMEDFDA UDI041382 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04048675041382 EUDAMEDFDA UDI
- Basic UDI-DI
- B-04048675041382 EUDAMED
- 510(k) Number
- K971198 FDA UDI
- FDA Product Code
- FMT FDA UDI
- EMDN Code
- Z12080407 NEONATAL RADIANT WARMERS EUDAMED
- GMDN Term
- Infant warmer FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 880.5130 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
Yes
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
Babytherm 8004 System by Drägerwerk AG & Co. KGaA — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Cleared under the same submission
K971198 also covers:
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Drägerwerk AG & Co. KGaA
Sources (2)
- FDA UDI e8ae9449-7b35-4ebd-860f-e78352bbe4d2 35 fields · synced Oct 7, 2026
- EUDAMED 9d34d41b-d20d-4c80-9ad2-df33bff882f3 61 fields · synced Oct 7, 2026