Skip to content

Hudson Rci IPN039346

by Teleflex Incorporated

Hudson Rci IPN039346 (5364) is a Class II device made by Teleflex Incorporated, cleared under FDA 510(k) K964719 on 21 Feb 1997 and listed in FDA GUDID since 17 Sep 2019 (UDI-DI 14026704662637), active as of 23 Oct 2026. One FDA recall is linked to it.

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

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

510(k) K964719

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 Number14026704662637 UDI-DI Date17 Sep 2019ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK964719 Date21 Feb 1997DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K964719 decided 21 Feb 1997 Active
  • FDA GUDID UDI-DI 14026704662637 listed 17 Sep 2019 Listed

Recalls

1 recall · FDA

    • Terminated Z-1809-2015 FDA Class I initiated 14 May 2015

    The intake port may be blocked which can cause the bag to fail to fill.

Timeline

3 dated events

  1. Cleared FDA 510(k) K964719
  2. Recall initiated FDA recalls Z-1809-2015
  3. Listed FDA GUDID 14026704662637

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Hudson Rci
Generic name
Pulmonary resuscitator, manual, single-use
Model / Ref / Catalog
IPN039346, 5364
Primary DI / UDI-DI
14026704662637
510(k) Number
FDA product code
BTM
GMDN term
Pulmonary resuscitator, manual, single-use
Device class
Class II
Regulation number
868.5915
GUDID distribution status
In Commercial Distribution

Related devices

Category: Pulmonary resuscitator, manual, single-use

Cleared under the same submission (K964719)

and 8 more cleared under K964719

Similar devices in this category

Other devices filed under Pulmonary resuscitator, manual, single-use.

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 (10, all answered No)