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Rusch IPN054284

by Teleflex Incorporated

Ref 664176-000220

Rusch IPN054284 (570822) is an indwelling urethral drainage balloon catheter (EU MDD Class IIa; FDA Class II; FDA product code EZL, Catheter, Retention Type, Balloon) made by Teleflex Incorporated, registered in EUDAMED on 14 Jul 2026 (Basic UDI-DI B-14026704612557), cleared under FDA 510(k) K162989 on 24 Feb 2017 and listed in FDA GUDID since 11 Mar 2017 (UDI-DI 14026704612557), active as of 25 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 25 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K162989

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-14026704612557 Basic UDI-DI 14026704612557UDI-DIDate14 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number14026704612557 UDI-DI Date11 Mar 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK162989 Date24 Feb 2017DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-14026704612557 registered 14 Jul 2026 Active
  • FDA 510(k) K162989 decided 24 Feb 2017 Active
  • FDA GUDID UDI-DI 14026704612557 listed 11 Mar 2017 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K162989
  2. Listed FDA GUDID 14026704612557
  3. Registered EUDAMED B-14026704612557

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  • Withdrawn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
Postoperative Foley Catheter EUDAMED
Rusch GUDID
Generic name
Indwelling urethral drainage balloon catheter, non-antimicrobial
Device name
Softsimplastic 3W 75ml Couvelaire C
Model / Ref / Catalog
664176-000220 EUDAMED
IPN054284 GUDID
570822 GUDID
Primary DI / UDI-DI
14026704612557
Basic UDI-DI
B-14026704612557
510(k) Number
FDA product code
EZL
EMDN code
U010202 Urethral prostatic and bladder catheters, couvelaire, with balloon
GMDN term
Indwelling urethral drainage balloon catheter, non-antimicrobial
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
876.5130
EU registration type
Legacy device (under a directive)
EU market of registration
Ireland
GUDID distribution status
In Commercial Distribution
Size
Outer Diameter — 7.3 Millimeter

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
664176-000220
GUDID
IPN054284
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: Indwelling urethral drainage balloon catheter, non-antimicrobial

Cleared under the same submission (K162989)

and 8 more cleared under K162989

Similar devices in this category

Other devices filed under URETHRAL PROSTATIC AND BLADDER CATHETERS, WITH BALLOON.

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

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