Identity
- Trade Name
- plasmatherm FDA UDI
- Generic Name
- Cryopreserved blood/tissue thawing unit FDA UDI
- Device Name
- plasmatherm EUDAMEDThawing and warming device for frozen Plasma (FFP, PF24, AHF), Whole Blood, RBC and IV solution FDA UDI
- Model / Reference
- 00000460 EUDAMEDUS-TCP FDA UDI
- Description
- Thawing and warming device for frozen Plasma (FFP, PF24, AHF), Whole Blood, RBC and IV solution FDA UDI
Identifiers
- Catalog Number
- 00000460 FDA UDI
- Primary DI / UDI-DI
- 04059201000018 EUDAMEDFDA UDI
- Basic UDI-DI
- 4059201plasmathermTJ EUDAMED
- Direct Marketing DI
- 04059201000018 EUDAMED
- FDA Product Code
- KZL FDA UDI
- EMDN Code
- Z12019009 THAWING UNITS EUDAMED
- GMDN Term
- Cryopreserved blood/tissue thawing unit FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 864.9205 FDA UDI
- Commercial Distribution
- 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
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
plasmatherm by Barkey GmbH & Co. KG — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 4059201plasmathermTJ | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Barkey GmbH & Co. KG
- EUDAMED SRN
- DE-MF-000005854
Sources (2)
- EUDAMED 319d2643-f14b-4d99-8b01-95d0d17d4c53 61 fields · synced Jul 9, 2026
- FDA UDI fbeaffaf-f488-4a5b-8c4a-61487cc1b8de 37 fields · synced May 30, 2026