Vacuette 454372H
Vacuette 454372H is an evacuated blood collection tube IVD (FDA Class II; FDA product code JKA, Tubes, vials, systems, serum separators, blood collection) made by Greiner Bio - One GmbH, listed under FDA premarket submission BK040066 and listed in FDA GUDID since 6 Aug 2020 (UDI-DI 29120049208566), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
510(k) BK040066
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number29120049208566 | Date6 Aug 2020 | StatusListed |
| United States | FDA 510(k) | NumberBK040066 | Date— | StatusActive |
Official records
- AccessGUDID record 29120049208566
Across registries
- FDA premarket submission BK040066 Active
- FDA GUDID UDI-DI 29120049208566 listed 6 Aug 2020 Listed
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Vacuette
- Generic name
- Evacuated blood collection tube IVD, no additive
- Model / Ref / Catalog
- 454372H
- Primary DI / UDI-DI
- 29120049208566
- FDA product code
- JKA
- GMDN term
- Evacuated blood collection tube IVD, no additive
- Device class
- Class II
- Regulation number
- 862.1675
- GUDID distribution status
- In Commercial Distribution
Similar devices
Other devices filed under FDA product code JKA (Tubes, vials, systems, serum separators, blood collection).
- MODIFICATION TO MYALLERGY TEST by Immunetech Corporation
- VACUTAINER(R) BRAND PLUS PST(TM) PLASMA SEPARATION TUBE by Bd Becton Dickinson Vacutainer Systems Preanalytic
- S-Monovette® 02.1067.001 by Sarstedt Aktiengesellschaft & Co.KG
- VACUTAINER BRAND SAFETY-LOK BLOOD COLLECTION SET by Bd Becton Dickinson Vacutainer Systems Preanalytic
- BD A-Line™ Arterial Blood Collection Syringe 364378 by Becton, Dickinson U.K. Limited
- S-Monovette® 2,7 ml EDTA Pink 04.1917.002 by Sarstedt Aktiengesellschaft & Co.KG
- GREINER VACUETTE BLOOD COLLECTION TUBE by Greiner America, Inc.
- SAFETY NEEDLE by SARSTEDT, INC.
- BD Vacutainer Push Button Blood Collection Set, BD Vacutainer Push Button Blood Collection Set with Pre-Attached Holder by Becton, Dickinson and Company
- STATSPIN STATSAMPLER by Statspin Technologies