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Rusch IPN041782

by Teleflex Incorporated

Rusch IPN041782 (120000-000080) is a Class II device made by Teleflex Incorporated, cleared under FDA 510(k) K955564 on 28 Jun 1996 and listed in FDA GUDID since 16 Oct 2015 (UDI-DI 04026704009817), 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) K955564

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 Number04026704009817 UDI-DI Date16 Oct 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK955564 Date28 Jun 1996DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K955564 decided 28 Jun 1996 Active
  • FDA GUDID UDI-DI 04026704009817 listed 16 Oct 2015 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K955564
  2. Listed FDA GUDID 04026704009817

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  • Withdrawn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
Tracheostomy tube, non-reinforced, non-customized, reusable
Model / Ref / Catalog
IPN041782, 120000-000080
Primary DI / UDI-DI
04026704009817
510(k) Number
FDA product code
JOH
GMDN term
Tracheostomy tube, non-reinforced, non-customized, reusable
Device class
Class II
Regulation number
868.5800
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Size
Lumen/Inner Diameter — 8 Millimeter
Outer Diameter — 11.4 Millimeter

Related devices

Category: Tracheostomy tube, non-reinforced, non-customized, reusable

Cleared under the same submission (K955564)

and 8 more cleared under K955564

Similar devices

Other devices filed under FDA product code JOH (Tube tracheostomy and tube cuff).

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See all devices from Teleflex Incorporated →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (9, all answered No)