Identity
- Trade Name
- OCS Lung System FDA UDI
- Generic Name
- Lung donor-organ preservation/transport perfusion set FDA UDI
- Device Name
- OCS Lung Perfusion Set FDA UDI
- Model / Reference
- 2200 FDA UDI
- Description
- OCS Lung Perfusion Set FDA UDI
Identifiers
- Catalog Number
- 2200 FDA UDI
- Primary DI / UDI-DI
- B00938535 FDA UDI
- FDA Product Code
- QBA FDA UDI
- GMDN Term
- Lung 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
- Height — 21 Inch FDA UDIWidth — 27 Inch FDA UDILength — 27 Inch FDA UDI
Category: Lung donor-organ preservation/transport perfusion set
OCS Lung System by TransMedics, Inc — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- TransMedics, Inc
Sources (1)
- FDA UDI be6562d6-ad1f-4424-91e5-b8720075f6a1 36 fields · synced Jun 6, 2026