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Rusch IPN041632

by Teleflex Incorporated

Ref 112682-000065

Rusch IPN041632 (112682065) is a device classified as Class IIa in the EU and Class II in the US made by Teleflex Incorporated, registered in EUDAMED on 6 Jul 2026 (Basic UDI-DI B-04026704325269), cleared under FDA 510(k) K132415 on 6 Jun 2014 and listed in FDA GUDID since 16 Oct 2015 (UDI-DI 04026704325269), 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) K132415

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-04026704325269 Basic UDI-DI 04026704325269UDI-DIDate6 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04026704325269 UDI-DI Date16 Oct 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK132415 Date6 Jun 2014DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-04026704325269 registered 6 Jul 2026 Active
  • FDA 510(k) K132415 decided 6 Jun 2014 Active
  • FDA GUDID UDI-DI 04026704325269 listed 16 Oct 2015 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K132415
  2. Listed FDA GUDID 04026704325269
  3. Registered EUDAMED B-04026704325269

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  • Withdrawn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
Super Safety Silk Endotracheal Tube - with Cuff - Murphy - Sterile Pack EUDAMED
Rusch GUDID
Generic name
Basic endotracheal tube, single-use
Device name
Tracheal Tube, Cuffed, Murphy
Model / Ref / Catalog
112682-000065 EUDAMED
IPN041632 GUDID
112682065 GUDID
Primary DI / UDI-DI
04026704325269
Basic UDI-DI
B-04026704325269
510(k) Number
FDA product code
BTR
EMDN code
R01030201 Endotracheal tubes, cuffed, not reinforced
GMDN term
Basic endotracheal tube, single-use
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
868.5730
EU registration type
Legacy device (under a directive)
EU market of registration
Ireland
GUDID distribution status
In Commercial Distribution
Size
Height — 24 Millimeter
Outer Diameter — 9.3 Millimeter
Length — 300 Millimeter
Width — 25 Millimeter

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
112682-000065
GUDID
IPN041632
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: Basic endotracheal tube, single-use

Cleared under the same submission (K132415)

and 8 more cleared under K132415

Similar devices in this category

Other devices filed under ENDOTRACHEAL TUBES, CUFFED, NOT REINFORCED.

Other devices from Teleflex Incorporated

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    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

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (19, all answered No)