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Cook-Swartz G21364

by Cook Vandergrift Inc

Ref DP-CAB01

Cook-Swartz G21364 (DP-CAB01) is a device classified as Class I in the EU and Class II in the US made by Cook Vandergrift Inc, registered in EUDAMED on 28 May 2026 (Basic UDI-DI B-00827002213647) and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 00827002213647), active as of 8 Nov 2026.

Active European Union. Also listed in GUDID (US).

CE MDD

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 8 Nov 2026.

Regulatory status

as of registry sync 8 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00827002213647 Basic UDI-DI 00827002213647UDI-DIDate28 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00827002213647 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-00827002213647 registered 28 May 2026 Active
  • FDA GUDID UDI-DI 00827002213647 listed 24 Sep 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00827002213647
  2. Registered EUDAMED B-00827002213647

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
Cook-Swartz
Generic name
Electrical-only medical device connection cable, single-use
Model / Ref / Catalog
DP-CAB01, G21364
Primary DI / UDI-DI
00827002213647
Basic UDI-DI
B-00827002213647
FDA product code
ITX
EMDN code
Z12040111 Blood flow meters
GMDN term
Electrical-only medical device connection cable, single-use
Device class
Class I EUDAMED
Class II GUDID
Regulation number
892.1570
EU registration type
Legacy device (under a directive)
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
DP-CAB01
GUDID
G21364
Device classEUDAMED
Class I
GUDID
Class II

Device class is stated on each registry's own scale: Class I 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: Electrical-only medical device connection cable, single-use

Similar devices in this category

Other devices filed under BLOOD FLOW METERS.

Other devices from Cook Vandergrift Inc

See all devices from Cook Vandergrift Inc →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (17, all answered No)