Identity
- Trade Name
- OCS Liver System FDA UDI
- Generic Name
- Liver donor-organ preservation/transport system FDA UDI
- Device Name
- OCS Liver Console EUDAMEDFDA UDI
- Model / Reference
- 100005048 EUDAMED3000 EUDAMEDFDA UDI
- Description
- OCS Liver Console FDA UDI
Identifiers
- Catalog Number
- 3000 FDA UDI
- Primary DI / UDI-DI
- B009OCSLiverConsoleKE EUDAMEDB00950480 FDA UDI
- Basic UDI-DI
- ++B009OCSLiverConsoleKE EUDAMED
- Direct Marketing DI
- B00950480 EUDAMED
- PMA Number
- P200031 FDA UDI
- FDA Product Code
- QQK FDA UDI
- EMDN Code
- Z12019002 EQUIPMENT FOR THE TRANSPORT OF ORGANIC MATERIAL EUDAMED
- GMDN Term
- Liver donor-organ preservation/transport system FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass III 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
Yes
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
Dimensions & Sizes
- Size
- Length — 17 Inch FDA UDIHeight — 29 Inch FDA UDIWidth — 28 Inch FDA UDI
OCS Liver Console by TransMedics, Inc — 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 | ++B009OCSLiverConsoleKE | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- TransMedics, Inc
- EUDAMED SRN
- US-MF-000029912
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED f7c4c066-b522-43c1-8657-7fa15b5000db 61 fields · synced Jun 20, 2026
- FDA UDI f6c811bf-174a-4137-bd9b-61fcd3fb4b60 38 fields · synced May 30, 2026