Vacuette 450070
Vacuette 450070 is a Class II device made by Greiner Bio - One GmbH, cleared under FDA 510(k) K981619 on 15 Jul 1998 and listed in FDA GUDID since 23 Sep 2016 (UDI-DI 29120017570176), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number29120017570176 | Date23 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK981619 | Date15 Jul 1998 | StatusActive |
Official records
- AccessGUDID record 29120017570176
- FDA 510(k) database K981619
Across registries
- FDA 510(k) K981619 decided 15 Jul 1998 Active
- FDA GUDID UDI-DI 29120017570176 listed 23 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K981619
- Listed FDA GUDID 29120017570176
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Vacuette
- Generic name
- Luer-ended blood collection tube spike
- Model / Ref / Catalog
- 450070
- Primary DI / UDI-DI
- 29120017570176
- 510(k) Number
- FDA product code
- FMI
- GMDN term
- Luer-ended blood collection tube spike
- Device class
- Class II
- Regulation number
- 880.5570
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Luer-ended blood collection tube spike.