Skip to content

Cool Point™ H701666

by Irvine Biomedical, Inc.

Ref H701666

Cool Point™ H701666 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 P060019 on 16 Mar 2007 and listed in FDA GUDID since 12 Jan 2024 (UDI-DI 05415067016669), active as of 23 Oct 2026.

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 Number5414734ABC00326E Basic UDI-DI 05415067016669UDI-DIDate24 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05415067016669 UDI-DI Date12 Jan 2024ListedStatusListed 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 5414734ABC00326E registered 24 Aug 2026 Active
  • FDA PMA P060019 decided 16 Mar 2007 Active
  • FDA GUDID UDI-DI 05415067016669 listed 12 Jan 2024 Listed

Recalls

1 recall · FDA

    • Terminated Z-1032-2012 FDA Not yet classified initiated 5 Jan 2012 on shared PMA P060019

    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.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Timeline

4 dated events

  1. Approved FDA PMA P060019
  2. Recall initiated FDA recalls Z-1032-2012
  3. Listed FDA GUDID 05415067016669
  4. 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  • Withdrawn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

Trade name
Cool Point™
Generic name
Electrical-only medical device connection cable, reusable
Device name
Cool Point Accessories
Model / Ref / Catalog
H701666
Primary DI / UDI-DI
05415067016669
Basic UDI-DI
5414734ABC00326E
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

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 (P060019)

and 8 more cleared under P060019

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)