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Buddy Lite With Ac, Battery Housing And Heater Unit, Germany
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- BUDDY LITE WITH AC, BATTERY HOUSING AND HEATER UNIT,GERMANY FDA UDI
- Generic Name
- Conduction blood/fluid warmer FDA UDI
- Device Name
- ASSY, BUDDY LITE WITH AC, BATTERY HOUSING AND HEATER UNIT, GERMANY, CHARGER FDA UDI
- Model / Reference
- 905-00023-G FDA UDI
- Description
- ASSY, BUDDY LITE WITH AC, BATTERY HOUSING AND HEATER UNIT, GERMANY, CHARGER FDA UDI
Identifiers
- Primary DI / UDI-DI
- 50896128002447 FDA UDI
- 510(k) Number
- K112639 FDA UDI
- FDA Product Code
- BSB FDA UDI
- GMDN Term
- Conduction blood/fluid warmer FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.9205 FDA UDI
- Commercial Distribution
- Not 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
Yes
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
Buddy Lite With Ac, Battery Housing And Heater Unit, Germany by Belmont Instrument Corp. — Class II — FDA UDI — listed in FDA GUDID
Cleared under the same submission
K112639 also covers:
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
- Belmont Instrument Corp.
Sources (1)
- FDA UDI d03293e0-d804-4d59-b2f7-4a7fc209df67 35 fields · synced Jun 1, 2026