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Cool Point™ 85785

by Irvine Biomedical, Inc.

Ref 85785

Cool Point™ 85785 is a device classified as Class IIa in the EU and Class III in the US made by Irvine Biomedical, Inc., registered in EUDAMED on 28 Aug 2026 (Basic UDI-DI 5414734ABS0021BR), approved under FDA PMA P060019 on 16 Mar 2007 and listed in FDA GUDID since 29 Sep 2014 (UDI-DI 05414734258616), active as of 23 Oct 2026. One FDA recall is 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

1 closed

Documents

None linked in EUDAMED

A group certificate may exist

PMA P060019

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 Number5414734ABS0021BR Basic UDI-DI 05414734258616UDI-DIDate28 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05414734258616 UDI-DI Date29 Sep 2014ListedStatusListed GUDID: in commercial distribution
United StatesFDA PMAAPPR GUDID from GUDID Approved NumberP060019 Date16 Mar 2007DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 5414734ABS0021BR registered 28 Aug 2026 Active
  • FDA PMA P060019 decided 16 Mar 2007 Active
  • FDA GUDID UDI-DI 05414734258616 listed 29 Sep 2014 Listed

Recalls

1 recall · FDA

    • Terminated Z-1032-2012 FDA Not yet classified initiated 5 Jan 2012

    Two St Jude Medical 1500T9 RF Generator units were distributed to customers while still under FDA review as part of a PMA supplement to the approved PMA applications.

Timeline

4 dated events

  1. Approved FDA PMA P060019
  2. Recall initiated FDA recalls Z-1032-2012
  3. Listed FDA GUDID 05414734258616
  4. Registered EUDAMED 5414734ABS0021BR

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  • Withdrawn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
Cool Point™
Generic name
Cardiac ablation system irrigation tubing set
Device name
Cool Point Tubing Set
Model / Ref / Catalog
85785
Primary DI / UDI-DI
05414734258616
Basic UDI-DI
5414734ABS0021BR
PMA number
FDA product code
OAD
EMDN code
A03040299 Irrigation kits, single-use - other
GMDN term
Cardiac ablation system irrigation tubing set
Device class
Class IIa EUDAMED
Class III GUDID
EU registration type
Standard device
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class III

Device class is stated on each registry's own scale: Class IIa 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: Cardiac ablation system irrigation tubing set

Cleared under the same submission (P060019)

and 8 more cleared under P060019

Similar devices in this category

Other devices filed under IRRIGATION KITS, SINGLE-USE - OTHER.

Other devices from Irvine Biomedical, Inc.(Ibi)

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

Properties

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