Identity
- Trade Name
- OCS Lung System FDA UDI
- Generic Name
- Donor-organ preservation/transport system gas cylinder regulator FDA UDI
- Device Name
- OCS Lung Monitoring Gas Regulator Kit FDA UDI
- Model / Reference
- 2464 FDA UDI
- Description
- OCS Lung Monitoring Gas Regulator Kit FDA UDI
Identifiers
- Catalog Number
- 2464 FDA UDI
- Primary DI / UDI-DI
- B00939251 FDA UDI
- FDA Product Code
- QBA FDA UDI
- GMDN Term
- Donor-organ preservation/transport system gas cylinder regulator FDA UDI
Classification
- Device Class
- Class III FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Height — 3 Inch FDA UDIWidth — 12 Inch FDA UDILength — 10 Inch FDA UDI
Category: Donor-organ preservation/transport system gas cylinder regulator
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 |
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Manufacturer
- Manufacturer
- TransMedics, Inc
Sources (1)
- FDA UDI 3250cb73-c5bc-4ee1-b455-4a17fc7d8a55 37 fields · synced May 30, 2026