Identity
- Trade Name
- OCS Lung System FDA UDI
- Generic Name
- Lung donor-organ preservation/transport system FDA UDI
- Device Name
- OCS Lung Console EUDAMEDFDA UDI
- Model / Reference
- 100003924 EUDAMED2000 EUDAMEDFDA UDI
- Description
- OCS Lung Console FDA UDI
Identifiers
- Catalog Number
- 2000 FDA UDI
- Primary DI / UDI-DI
- B009OCSLungConsoleGY EUDAMEDB00939240 FDA UDI
- Basic UDI-DI
- ++B009OCSLungConsoleGY EUDAMED
- Direct Marketing DI
- B00939240 EUDAMED
- FDA Product Code
- QBA FDA UDI
- EMDN Code
- Z12050201 EXTRA-CORPOREAL CIRCULATION SYSTEMS EUDAMED
- GMDN Term
- Lung donor-organ preservation/transport system FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass III FDA UDI
- Market of Registration
- France EUDAMED
- 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
- Height — 29 Inch FDA UDIWidth — 28 Inch FDA UDILength — 17 Inch FDA UDI
OCS Lung 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 | ++B009OCSLungConsoleGY | 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 78ce992a-853c-4cc4-8224-dac4947314f6 61 fields · synced Jul 28, 2026
- FDA UDI 62b13ba6-1a2d-40ae-83b1-d69be8b1b82f 37 fields · synced May 29, 2026