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Rusch IPN044051

by Teleflex Incorporated

Rusch IPN044051 (230100000) is an endotracheal tube cuff inflator (FDA Class II; FDA product code BSK, Cuff, tracheal tube, inflatable) made by Teleflex Incorporated, cleared under FDA 510(k) K951046 on 6 Apr 1995 and listed in FDA GUDID since 16 Oct 2015 (UDI-DI 04026704554102), 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) K951046

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 Number04026704554102 UDI-DI Date16 Oct 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK951046 Date6 Apr 1995DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K951046 decided 6 Apr 1995 Active
  • FDA GUDID UDI-DI 04026704554102 listed 16 Oct 2015 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K951046
  2. Listed FDA GUDID 04026704554102

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Rusch
Generic name
Endotracheal tube cuff inflator
Model / Ref / Catalog
IPN044051, 230100000
Primary DI / UDI-DI
04026704554102
510(k) Number
FDA product code
BSK
GMDN term
Endotracheal tube cuff inflator
Device class
Class II
Regulation number
868.5750
GUDID distribution status
In Commercial Distribution
Size
Length — 103.5 Centimeter

Similar devices

Other devices filed under FDA product code BSK (Cuff, tracheal tube, inflatable).

Other devices from Teleflex Incorporated

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  • 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)