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Gibeck IPN042947

by Teleflex Incorporated

Gibeck IPN042947 (18832) is a Class I device made by Teleflex Incorporated, cleared under FDA 510(k) K881657 on 24 Jun 1988 and listed in FDA GUDID since 16 Sep 2016 (UDI-DI 04026704388318), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K881657

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number04026704388318 UDI-DI Date16 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK881657 Date24 Jun 1988DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K881657 decided 24 Jun 1988 Active
  • FDA GUDID UDI-DI 04026704388318 listed 16 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K881657
  2. Listed FDA GUDID 04026704388318

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Gibeck
Generic name
Heat/moisture exchanger/microbial medical gas filter
Model / Ref / Catalog
IPN042947, 18832
Primary DI / UDI-DI
04026704388318
510(k) Number
FDA product code
BYD
GMDN term
Heat/moisture exchanger/microbial medical gas filter
Device class
Class I
Regulation number
868.5375
GUDID distribution status
In Commercial Distribution

Similar devices in this category

Other devices filed under Heat/moisture exchanger/microbial medical gas filter.

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  • Arrow IPNB00827 Open recall

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See all devices from Teleflex Incorporated →

Properties

  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (10, all answered No)