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Gibeck IPN929914

by Teleflex Incorporated

Ref 45512Model IPN929914

Gibeck IPN929914 (45512) is a device classified as Class IIa in the EU and Class I in the US made by Teleflex Incorporated, registered in EUDAMED on 31 Jul 2026 (Basic UDI-DI B-14026704927743) and listed in FDA GUDID since 31 Jul 2025 (UDI-DI 14026704927743), active as of 25 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 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-14026704927743 Basic UDI-DI 14026704927743UDI-DIDate31 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number14026704927743 UDI-DI Date31 Jul 2025ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-14026704927743 registered 31 Jul 2026 Active
  • FDA GUDID UDI-DI 14026704927743 listed 31 Jul 2025 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 14026704927743
  2. Registered EUDAMED B-14026704927743

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  • Withdrawn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
Oxy-Vent with Tubing EUDAMED
Gibeck GUDID
Generic name
Heat/moisture exchanger, single-use
Device name
Oxy-Vent
Model / Ref / Catalog
IPN929914, 45512
Primary DI / UDI-DI
14026704927743
Basic UDI-DI
B-14026704927743
FDA product code
BYD
EMDN code
R060280 Humidification systems - accessories
GMDN term
Heat/moisture exchanger, single-use
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
868.5375
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: Heat/moisture exchanger, single-use

Similar devices in this category

Other devices filed under HUMIDIFICATION SYSTEMS - ACCESSORIES.

Other devices from Teleflex Incorporated

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  • Arrow IPNB00827 Open recall

    Class II

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)