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Lifeline ECG 2 AED configuration DDU-2960

by Defibtech, L.L.C.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

9 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 Number10815098021540 UDI-DI Date9 Dec 2025ListedStatusListed GUDID: in commercial distribution

Recalls

9 recalls · 9 ongoing · FDA

  • 5 recalls, same reason

    • Ongoing Z-1691-2025 FDA Class II initiated 18 Mar 2025
    • Ongoing Z-1690-2025 FDA Class II initiated 18 Mar 2025
    • Ongoing Z-1692-2025 FDA Class II initiated 18 Mar 2025
    • Ongoing Z-1693-2025 FDA Class II initiated 18 Mar 2025
    • Ongoing Z-1694-2025 FDA Class II initiated 18 Mar 2025

    It was noticed there was no Italian translation included for the AED. Article 16 of the Swiss Medical Devices Ordinance (MedDO) states that product information (labelling and instructions for use) should be provided in all three official languages of Switzerland (German, French, and Italian).

  • 3 recalls, same reason

    • Ongoing Z-0505-2025 FDA Class II initiated 14 Oct 2024
    • Ongoing Z-0504-2025 FDA Class II initiated 14 Oct 2024
    • Ongoing Z-0503-2025 FDA Class II initiated 14 Oct 2024

    Within the Irish Market, that a Field Safety Notice is being issued due to a select number of authorized labelled Defibtech AED Pads, which have had the authorized label removed and an unauthorized label applied, could potentially lead to expired Defibtech AED Pads appearing as though they are within the acceptable shelf life.there is a possibility of hydrogel drying, which may result in poor electrical connection to the patient, which can reduce the energy delivered to the patient

    • Ongoing Z-0502-2025 FDA Class II initiated 14 Oct 2024

    Within the Irish Market, a Field Safety Notice is being issued due to a select number of authorized labelled Defibtech AED Pads, which have had the authorized label removed and an unauthorized label applied, could lead to expired Defibtech AED Pads appearing as though they are within the acceptable shelf life. There is a possibility of hydrogel drying, which may result in poor electrical connection to the patient, which can reduce the energy delivered to the patient.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Lifeline ECG 2 AED configuration
Generic Name
Non-rechargeable professional semi-automated external defibrillator
Model / Reference
DDU-2960
Primary DI / UDI-DI
10815098021540
PMA Number
FDA Product Code
MKJ
GMDN Term
Non-rechargeable professional semi-automated external defibrillator
Device Class
Class III
Regulation Number
870.5310
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (P160032)

Show all (12)

Other devices from Defibtech, L.L.C.

See all devices from Defibtech, L.L.C. →

Properties

  • Serial Number

Other properties (13)

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