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Ibi-85710

by Irvine Biomedical, Inc.

Ref IBI-85710

Ibi-85710 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 5414734ABC00326E), approved under FDA PMA P040014 on 14 Jan 2005 and listed in FDA GUDID since 31 Oct 2014 (UDI-DI 05414734308830), active as of 23 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 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number5414734ABC00326E Basic UDI-DI 05414734308830UDI-DIDate24 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05414734308830 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 5414734ABC00326E registered 24 Aug 2026 Active
  • FDA PMA P040014 decided 14 Jan 2005 Active
  • FDA GUDID UDI-DI 05414734308830 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 05414734308830
  6. Registered EUDAMED 5414734ABC00326E

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

Generic name
Electrical-only medical device connection cable, reusable
Device name
Cool Point Accessories
Model / Ref / Catalog
IBI-85710
Primary DI / UDI-DI
05414734308830
Basic UDI-DI
5414734ABC00326E
Direct marketing DI
05414734308830
PMA number
FDA product code
LPB
EMDN code
Z12019080 Various instruments for general and multidisciplinary surgery - hardware accessories
GMDN term
Electrical-only medical device connection cable, reusable
Device class
Class I EUDAMED
Class III GUDID
EU registration type
Standard device
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution
Size
Length — 10 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, reusable

Cleared under the same submission (P040014)

and 8 more cleared under P040014

Similar devices in this category

Other devices filed under VARIOUS INSTRUMENTS FOR GENERAL AND MULTIDISCIPLINARY SURGERY - HARDWARE ACCESSORIES.

Other devices from Irvine Biomedical, Inc.(Ibi)

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

Properties

  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (22, all answered No)