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Vacuette 450091V1

by Greiner Bio - One GmbH

Part of a family of 17 devices: see the family page

Ref 450091V1Model SAFETY Blood Collection/Infusion Sets

Vacuette 450091V1 is a device classified as Class IIa in the EU and Class II in the US made by Greiner Bio - One GmbH, registered in EUDAMED on 16 Jul 2026 (Basic UDI-DI 912001757G0000077AA), cleared under FDA 510(k) K121908 on 25 Jul 2012 (2 earlier submissions) and listed in FDA GUDID since 7 Dec 2023 (UDI-DI 19120049208798), active as of 23 Oct 2026. One FDA recall is linked to it.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None ongoing

2 closed

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K121908

+2 more

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number912001757G0000077AA Basic UDI-DI 19120049208798UDI-DIDate16 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number19120049208798 UDI-DI Date7 Dec 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Special NumberK121908 Date25 Jul 2012DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 912001757G0000077AA registered 16 Jul 2026 Active
  • FDA 510(k) K121908 decided 25 Jul 2012 Active· +2 more in the status table
  • FDA GUDID UDI-DI 19120049208798 listed 7 Dec 2023 Listed

Recalls

2 recalls · FDA

    • Terminated Z-0835-2013 FDA Class II initiated 1 Feb 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 FDA Unclassified (pre-2012) initiated 10 Mar 2003 on shared 510(k) K011786

    The needle portion of the Safety Blood Collection Sets, may become separated from the body of the Luer Adapter.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Timeline

7 dated events

  1. Cleared FDA 510(k) K011786
  2. Recall initiated FDA recalls Z-0797-03
  3. Cleared FDA 510(k) K080235
  4. Cleared FDA 510(k) K121908
  5. Recall initiated FDA recalls Z-0835-2013
  6. Listed FDA GUDID 19120049208798
  7. Registered EUDAMED 912001757G0000077AA

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
SAFETY Blood Collection/Infusion Set 21G x 3/4" tubing length 7 1/2" (19 cm), single-packed, sterile EUDAMED
Vacuette GUDID
Generic name
Basic intravenous administration set, invasive
Device name
SAFETY Blood Collection/Infusion Sets
Model / Ref / Catalog
450091V1, SAFETY Blood Collection/Infusion Sets
Primary DI / UDI-DI
19120049208798
Basic UDI-DI
912001757G0000077AA
510(k) Number
FDA product code
FMI
EMDN code
A01010201 Butterfly needles, with safety systems
GMDN term
Basic intravenous administration set, invasive
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
880.5570
EU registration type
Standard device
EU market of registration
Austria
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class II

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Basic intravenous administration set, invasive

Cleared under the same submission (K011786)

and 8 more cleared under K011786

Cleared under the same submission (K080235)

and 8 more cleared under K080235

Similar devices in this category

Other devices filed under BUTTERFLY NEEDLES, WITH SAFETY SYSTEMS.

Other devices from Greiner Bio - One GmbH

See all devices from Greiner Bio - One GmbH →

Properties

  • Supplied sterile
  • Single use
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction)
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (19, all answered No)