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MEDRAD® Twist & Go Disposable Syringe 150 mL with Quick Fill Tube

by Bayer Medical Care Inc.

Ref TAG 150 SYR

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

CE MDR 510(k)

Valid until

Not listed

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

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K964642↗

+1 more

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0616258TFCN-0086QS Basic UDI-DI Date19 Nov 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number00616258024561 UDI-DI Date6 May 2024ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) 510(k) NumberK964642 Date29 Apr 1997IssuedStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · 510(k) · GUDID

Trade Name
MEDRAD® Twist & Go Disposable Syringe 150 mL with Quick Fill Tube EUDAMED
MEDRAD® Twist & Go Disposable Syringe 150mL with Quick Fill Tube GUDID
Generic Name
Angiographic syringe
Model / Ref / Catalog
TAG 150 SYR
Primary DI / UDI-DI
00616258024561, 00616258024820
Basic UDI-DI
0616258TFCN-0086QS
510(k) Number
FDA Product Code
FPK
EMDN Code
A02010401 Syringes for contrast media injector, single-use
GMDN Term
Angiographic syringe
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
880.5440
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class II

Manufacturer details

EUDAMED SRN
US-MF-000007050
Authorised representative
Bayer Medical Care B.V. NL-AR-000000240

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Properties

  • Sterile
  • Single Use
  • CMR Substance
  • Prescription Use
  • Convenience Kit
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (16)

  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No