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Gibeck IPN929823

by Teleflex Incorporated

Ref 22362Model IPN929823

Gibeck IPN929823 (22362) is a device classified as Class IIa in the EU and Class I in the US made by Teleflex Incorporated, registered in EUDAMED on 14 Jul 2026 (Basic UDI-DI B-14026704929099) and listed in FDA GUDID since 30 Jul 2025 (UDI-DI 14026704929099), active as of 23 Oct 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 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-14026704929099 Basic UDI-DI 14026704929099UDI-DIDate14 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number14026704929099 UDI-DI Date30 Jul 2025ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-14026704929099 registered 14 Jul 2026 Active
  • FDA GUDID UDI-DI 14026704929099 listed 30 Jul 2025 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 14026704929099
  2. Registered EUDAMED B-14026704929099

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  • Withdrawn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
Expandi-Flex EUDAMED
Gibeck GUDID
Generic name
Breathing circuit catheter mount, single-use
Device name
Expandi-Flex Tube
Model / Ref / Catalog
IPN929823, 22362
Primary DI / UDI-DI
14026704929099
Basic UDI-DI
B-14026704929099
FDA product code
BZO
EMDN code
R020299 Mount catheters - other
GMDN term
Breathing circuit catheter mount, single-use
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
868.5975
EU registration type
Legacy device (under a directive)
EU market of registration
Ireland
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class I

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

Related devices

Category: Breathing circuit catheter mount, single-use

Similar devices in this category

Other devices filed under MOUNT CATHETERS - OTHER.

Other devices from Teleflex Incorporated

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See all devices from Teleflex Incorporated →

Properties

  • Single use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (19, all answered No)