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Gibeck IPN043768

by Teleflex Incorporated

Ref 19402

Gibeck IPN043768 (19402) is a device classified as Class IIa in the EU and Class II in the US made by Teleflex Incorporated, registered in EUDAMED on 23 Jul 2026 (Basic UDI-DI B-04026704348022), cleared under FDA 510(k) K964382 on 15 Apr 1997 and listed in FDA GUDID since 16 Sep 2016 (UDI-DI 04026704348022), active as of 23 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 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K964382

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-04026704348022 Basic UDI-DI 04026704348022UDI-DIDate23 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04026704348022 UDI-DI Date16 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK964382 Date15 Apr 1997DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-04026704348022 registered 23 Jul 2026 Active
  • FDA 510(k) K964382 decided 15 Apr 1997 Active
  • FDA GUDID UDI-DI 04026704348022 listed 16 Sep 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K964382
  2. Listed FDA GUDID 04026704348022
  3. Registered EUDAMED B-04026704348022

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  • Withdrawn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
Humid-Vent Filter Compact S EUDAMED
Gibeck GUDID
Generic name
Heat/moisture exchanger/microbial medical gas filter
Device name
Humid-Vent Filter Compact Straight
Model / Ref / Catalog
19402, IPN043768
Primary DI / UDI-DI
04026704348022
Basic UDI-DI
B-04026704348022
510(k) Number
FDA product code
CAH
EMDN code
R040102 Antibacterial and antiviral respiratory filters humidifiers
GMDN term
Heat/moisture exchanger/microbial medical gas filter
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
868.5260
EU registration type
Legacy device (under a directive)
EU market of registration
Ireland
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
19402
GUDID
IPN043768
Device classEUDAMED
Class IIa
GUDID
Class II

Device class is stated on each registry's own scale: Class IIa 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: Heat/moisture exchanger/microbial medical gas filter

Cleared under the same submission (K964382)

and 8 more cleared under K964382

Similar devices in this category

Other devices filed under ANTIBACTERIAL AND ANTIVIRAL RESPIRATORY FILTERS HUMIDIFIERS.

Other devices from Teleflex Incorporated

  • Arrow IPNB00820 Open recall

    Class II

  • Arrow IPNB00826 Open recall

    Class II

  • Arrow IPNB00822 Open recall

    Class II

  • Arrow IPNB00827 Open recall

    Class II

See all devices from Teleflex Incorporated →

Properties

  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (20, all answered No)