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Sjm™ Ibi-85763

by Irvine Biomedical, Inc.

Part of a family of 22 devices: see the family page

Ref IBI-85763

Sjm™ Ibi-85763 is a device classified as Class I in the EU and Class III in the US made by Irvine Biomedical, Inc., registered in EUDAMED on 24 Aug 2026 (Basic UDI-DI 5414734ABR0026BQ), approved under FDA PMA P040014 on 14 Jan 2005 and listed in FDA GUDID since 31 Oct 2014 (UDI-DI 05414734308977), active as of 25 Oct 2026. 3 FDA recalls are linked to it.

Active European Union and United States. Also listed in GUDID (US).

CE MDR PMA

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None ongoing

3 closed

Documents

None linked in EUDAMED

A group certificate may exist

PMA P040014

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/MDR EUDAMED Number5414734ABR0026BQ Basic UDI-DI 05414734308977UDI-DIDate24 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05414734308977 UDI-DI Date31 Oct 2014ListedStatusListed GUDID: in commercial distribution
United StatesFDA PMAAPPR GUDID from GUDID Approved NumberP040014 Date14 Jan 2005DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 5414734ABR0026BQ registered 24 Aug 2026 Active
  • FDA PMA P040014 decided 14 Jan 2005 Active
  • FDA GUDID UDI-DI 05414734308977 listed 31 Oct 2014 Listed

Recalls

3 recalls · FDA

  • 3 recalls, same reason

    • Terminated Z-3255-2011 FDA Unclassified (pre-2012) initiated 10 Feb 2011
    • Terminated Z-3256-2011 FDA Unclassified (pre-2012) initiated 10 Feb 2011
    • Terminated Z-3257-2011 FDA Unclassified (pre-2012) initiated 10 Feb 2011

    The recall was initiated because St. Jude Medical has confirmed that the Therapy Ablation Catheter, 4 mm Tip Thermistor Quadripolar, were packaged with the incorrect Instructions for Use (IFU). To ensure accuracy of device labeling, St. Jude Medical is requesting that the incorrect IFU be replaced with the enclose, correct version.

Timeline

6 dated events

  1. Approved FDA PMA P040014
  2. Recall initiated FDA recalls Z-3255-2011
  3. Recall initiated FDA recalls Z-3256-2011
  4. Recall initiated FDA recalls Z-3257-2011
  5. Listed FDA GUDID 05414734308977
  6. Registered EUDAMED 5414734ABR0026BQ

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA PMA Active

Specification

EUDAMED · GUDID

Trade name
Sjm™
Generic name
Electrical-only medical device connection cable, reprocessed
Device name
Sterile Cables
Model / Ref / Catalog
IBI-85763
Primary DI / UDI-DI
05414734308977
Basic UDI-DI
5414734ABR0026BQ
Direct marketing DI
05414734308977
PMA number
FDA product code
LPB
EMDN code
L0317 General surgery adapters and connectors, reusable
GMDN term
Electrical-only medical device connection cable, reprocessed
Device class
Class I EUDAMED
Class III GUDID
EU registration type
Standard device
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution
Sterilisation method
Ethylene Oxide
MRI safety
MR Unsafe
Size
Length — 8 Feet

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class I
GUDID
Class III

Device class is stated on each registry's own scale: Class I in the EU (EUDAMED), Class III in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Electrical-only medical device connection cable, reprocessed

Cleared under the same submission (P040014)

and 8 more cleared under P040014

Similar devices in this category

Other devices filed under GENERAL SURGERY ADAPTERS AND CONNECTORS, REUSABLE.

Other devices from Irvine Biomedical, Inc.(Ibi)

See all devices from Irvine Biomedical, Inc.(Ibi) →

Properties

  • Supplied sterile
  • Sterilise before use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (20, all answered No)