Identity
- Trade Name
- Barkey S-line FDA UDI
- Generic Name
- Conduction blood/fluid warmer FDA UDI
- Device Name
- The device delivers warm blood, blood products, and liquids to adult and pediatric patients FDA UDI
- Model / Reference
- 39 °C FDA UDI
- Description
- The device delivers warm blood, blood products, and liquids to adult and pediatric patients FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04059201002203 FDA UDI
- 510(k) Number
- K213191 FDA UDI
- FDA Product Code
- LGZ FDA UDI
- GMDN Term
- Conduction blood/fluid warmer FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5725 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
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
Category: Conduction blood/fluid warmer
Barkey S-line by Barkey GmbH & Co. KG — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Barkey GmbH & Co. KG
Sources (2)
- FDA UDI 86ac296b-d49d-4899-8ff7-8e05cb40687a 36 fields · synced Jun 19, 2026
- EUDAMED 1 fields · synced Jun 2, 2026