Identity
- Trade Name
- Organ Care System FDA UDI
- Generic Name
- Donor-organ preservation/transport system control unit FDA UDI
- Device Name
- OCS Wireless Monitor, Universal FDA UDI
- Model / Reference
- 2450 FDA UDI
- Description
- OCS Wireless Monitor, Universal FDA UDI
Identifiers
- Catalog Number
- 2450 FDA UDI
- Primary DI / UDI-DI
- B00939270 FDA UDI
- FDA Product Code
- QBA FDA UDI
- GMDN Term
- Donor-organ preservation/transport system control unit 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 — 3.5 Inch FDA UDIWidth — 8.5 Inch FDA UDILength — 9.5 Inch FDA UDI
Category: Donor-organ preservation/transport system control unit
Organ Care System by TransMedics, Inc — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Donor-organ preservation/transport system control unit.
- OCS Heart System — TransMedics, Inc · Class III
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 5705927f-39d6-4c74-916d-3790ccdc4f2f 37 fields · synced May 30, 2026