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Cool Point™ IBI-89003

by Irvine Biomedical, Inc.

Cool Point™ IBI-89003 is a Class III device made by Irvine Biomedical, Inc., approved under FDA PMA P060019 on 16 Mar 2007 and listed in FDA GUDID since 29 Sep 2014 (UDI-DI 05415067008985), active as of 23 Oct 2026. One FDA recall is linked to it.

Active United States. Also listed in GUDID (US).

PMA

Valid until

No expiry

PMA approval is not time-limited

FDA recalls

None ongoing

1 closed

Documents

PMA P060019

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number05415067008985 UDI-DI Date29 Sep 2014ListedStatusListed GUDID: in commercial distribution
United StatesFDA PMAAPPR from GUDID Approved NumberP060019 Date16 Mar 2007DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA PMA P060019 decided 16 Mar 2007 Active
  • FDA GUDID UDI-DI 05415067008985 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

3 dated events

  1. Approved FDA PMA P060019
  2. Recall initiated FDA recalls Z-1032-2012
  3. Listed FDA GUDID 05415067008985

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA PMA Active

Specification

GUDID

Trade name
Cool Point™
Generic name
Bedside infusion pump, single-channel
Model / Ref / Catalog
IBI-89003
Primary DI / UDI-DI
05415067008985
PMA number
FDA product code
OAD
GMDN term
Bedside infusion pump, single-channel
Device class
Class III
GUDID distribution status
In Commercial Distribution

Related devices

Category: Bedside infusion pump, single-channel

Cleared under the same submission (P060019)

and 8 more cleared under P060019

Similar devices

Other devices filed under FDA product code OAD (catheter, percutaneous, cardiac ablation, for treatment of atrial flutter).

Other devices from Irvine Biomedical, Inc.(Ibi)

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

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)