Identity
- Trade Name
- OCS Liver System FDA UDI
- Generic Name
- Liver donor-organ preservation/transport perfusion set FDA UDI
- Device Name
- OCS Liver Perfusion Set FDA UDI
- Model / Reference
- 3200 FDA UDI
- Description
- OCS Liver Perfusion Set FDA UDI
Identifiers
- Catalog Number
- 3200 FDA UDI
- Primary DI / UDI-DI
- B00944705 FDA UDI
- PMA Number
- P200031 FDA UDI
- FDA Product Code
- QQK FDA UDI
- GMDN Term
- Liver donor-organ preservation/transport perfusion set FDA UDI
Classification
- Device Class
- Class III FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Length — 27 Inch FDA UDIWidth — 27 Inch FDA UDIHeight — 21 Inch FDA UDI
Category: Liver donor-organ preservation/transport perfusion set
OCS Liver System by TransMedics, Inc — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
P200031 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 III | Pending data |
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Manufacturer
- Manufacturer
- TransMedics, Inc
Sources (1)
- FDA UDI a20e679d-5e85-4c9e-9507-b1785322977e 38 fields · synced May 31, 2026