Vacuette 450081
Vacuette 450081 is a Class II device made by Greiner Bio - One GmbH, cleared under FDA 510(k) K121908 on 25 Jul 2012 (2 earlier submissions) and listed in FDA GUDID since 23 Sep 2016 (UDI-DI 19120017570230), active as of 23 Oct 2026. One FDA recall is linked to it.
Active
510(k)
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number19120017570230 | Date23 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK121908 | Date25 Jul 2012 | StatusActive |
Official records
- AccessGUDID record 19120017570230
- FDA 510(k) database K121908
- FDA 510(k) database K080235
- FDA 510(k) database K011786
Across registries
- FDA 510(k) K121908 decided 25 Jul 2012 Active
- FDA GUDID UDI-DI 19120017570230 listed 23 Sep 2016 Listed
Recalls
-
- Terminated Z-0835-2013
The VACUETTE Safety Blood Collection Set + Luer Adapter may display leaking (small droplets) during use due to a crack on the luer connector piece.
-
- Terminated Z-0797-03
The needle portion of the Safety Blood Collection Sets, may become separated from the body of the Luer Adapter.
Timeline
- Cleared FDA 510(k) K011786
- Recall initiated FDA recalls Z-0797-03
- Cleared FDA 510(k) K080235
- Cleared FDA 510(k) K121908
- Recall initiated FDA recalls Z-0835-2013
- Listed FDA GUDID 19120017570230
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Vacuette
- Generic name
- Basic intravenous administration set, invasive
- Model / Ref / Catalog
- 450081
- Primary DI / UDI-DI
- 19120017570230
- FDA product code
- FMI
- GMDN term
- Basic intravenous administration set, invasive
- Device class
- Class II
- Regulation number
- 880.5570
- GUDID distribution status
- In Commercial Distribution
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