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Battery, Li-Ion, with Ifu, LP35 11335

by PHYSIO-CONTROL, Inc. 2 variants

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

17 ongoing

This device is named in the recall

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00883873760482 UDI-DI Date26 Sep 2025ListedStatusListed GUDID: in commercial distribution

Recalls

17 recalls · 17 ongoing · FDA

    • Ongoing Z-2065-2026 FDA Class II initiated 13 Apr 2026

    Some defibrillators serviced between July 2023 through November 2025 were serviced without objective evidence that a Performance Inspection Procedure (PIP) was conducted, and the inability to perform the device's intended use may result in potential harms such as delays or inability to provide therapy.

  • 2 recalls, same reason

    • Ongoing Z-2497-2025 FDA Class II initiated 22 Jul 2025
    • Ongoing Z-2498-2025 FDA Class II initiated 22 Jul 2025

    Due to required inspections not being performed on products/units that have gone through servicing.

    • Ongoing Z-1232-2025 FDA Class II initiated 3 Feb 2025

    Incorrect keypad was incorrectly installed onto a defibrillator/monitor.

    • Ongoing Z-1184-2025 FDA Class II initiated 21 Jan 2025

    Due to an error message that prevents users from utilizing carboxyhemoglobin saturation and methemoglobin saturation sensors on their monitor/defibrillator system.

    • Ongoing Z-0230-2025 FDA Class II initiated 30 Aug 2024

    Due to an out of tolerance tool being used on monitor/defibrillator systems.

    • Ongoing Z-0567-2024 FDA Class II initiated 6 Nov 2023

    AC Power Adapter (ACPA) may not charge the monitor/defibrillator batteries and may not allow the monitor/defibrillator to power on while plugged into the ACPA.

  • 10 recalls, same reason

    • Ongoing Z-0296-2024 FDA Class II initiated 29 Sep 2023
    • Ongoing Z-0303-2024 FDA Class II initiated 29 Sep 2023
    • Ongoing Z-0305-2024 FDA Class II initiated 29 Sep 2023
    • Ongoing Z-0302-2024 FDA Class II initiated 29 Sep 2023
    • Ongoing Z-0298-2024 FDA Class II initiated 29 Sep 2023
    • Ongoing Z-0301-2024 FDA Class II initiated 29 Sep 2023
    • Ongoing Z-0299-2024 FDA Class II initiated 29 Sep 2023
    • Ongoing Z-0297-2024 FDA Class II initiated 29 Sep 2023
    • Ongoing Z-0300-2024 FDA Class II initiated 29 Sep 2023
    • Ongoing Z-0304-2024 FDA Class II initiated 29 Sep 2023

    Their is a potential for battery pins to become loose within the defibrillator resulting in power issues.

Coverage

1 jurisdiction

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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Battery, Li-Ion, with Ifu, LP35
Generic Name
Portable/mobile rechargeable battery pack
Model / Ref / Catalog
11335, 11335-000009
Primary DI / UDI-DI
00883873760482
PMA Number
FDA Product Code
MKJ
GMDN Term
Portable/mobile rechargeable battery pack
Device Class
Class III
Regulation Number
870.5310
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (P160026)

Show all (12)

Other devices from PHYSIO-CONTROL, Inc.

See all devices from PHYSIO-CONTROL, Inc. →

Properties

  • Prescription Use
  • Lot / Batch Number
  • Manufacturing Date

Other properties (11)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No