metra Liver Perfusion Circuit Pack D0146-US
by Organox Limited United States GUDID
Product code QQK
Regulatory status
Recall ongoing. 1 ongoing FDA recall. See recalls
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number05060462240043 | Date15 Jun 2022 | StatusIn distribution |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — GUDID listing Listed
Recalls
-
- Ongoing Z-0501-2025
Battery movement led to damage of one of the battery cells causing it to short to the battery retention bracket
Specification
- Trade Name
- metra Liver Perfusion Circuit Pack
- Generic Name
- Liver donor-organ preservation/transport system
- Model / Reference
- D0146-US
- Primary DI / UDI-DI
- 05060462240043
- FDA Product Code
- QQK
- GMDN Term
- Liver donor-organ preservation/transport system
- Device Class
- Class III
- Commercial Distribution
- In Commercial Distribution
Other devices from Organox Limited
Properties & raw data
Show properties, registry sources and raw records
Other properties (7)
- Implantable: No
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Premarket Exempt: No
- Serial Number: No
Sources (1)
- FDA UDI db0afd20-7477-4cc0-aea3-b01732f649a6