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Cook G18813

by Cook Incorporated

Ref TBAYR-6

Cook G18813 (TBAYR-6) is a device classified as Class I in the EU and Class II in the US made by Cook Incorporated, registered in EUDAMED on 16 Jun 2026 (Basic UDI-DI B-00827002188136), cleared under FDA 510(k) K173105 on 22 Mar 2018 and listed in FDA GUDID since 5 Oct 2020 (UDI-DI 00827002188136), active as of 24 Oct 2026.

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

CE MDD 510(k)

Valid until

No date given

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

FDA recalls

None found

in data synced 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K173105

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00827002188136 Basic UDI-DI 00827002188136UDI-DIDate16 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00827002188136 UDI-DI Date5 Oct 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK173105 Date22 Mar 2018DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-00827002188136 registered 16 Jun 2026 Active
  • FDA 510(k) K173105 decided 22 Mar 2018 Active
  • FDA GUDID UDI-DI 00827002188136 listed 5 Oct 2020 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K173105
  2. Listed FDA GUDID 00827002188136
  3. Registered EUDAMED B-00827002188136

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
Cook
Generic name
In-line backflow valve, single-use
Model / Ref / Catalog
TBAYR-6, G18813
Primary DI / UDI-DI
00827002188136
Basic UDI-DI
B-00827002188136
510(k) Number
FDA product code
ODC
EMDN code
A070199 Adapters and connectors - other
GMDN term
In-line backflow valve, single-use
Device class
Class I EUDAMED
Class II GUDID
Regulation number
876.1500
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
TBAYR-6
GUDID
G18813
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: In-line backflow valve, single-use

Cleared under the same submission (K173105)

Similar devices in this category

Other devices filed under ADAPTERS AND CONNECTORS - OTHER.

Other devices from Cook Incorporated

See all devices from Cook Incorporated →

Properties

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