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Product Overview

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LIFEPAK 1000 defibrillator - 99425


Device Description

A portable electronic device designed to automatically detect cardiac arrhythmias (ventricular fibrillation/pulseless ventricular tachycardia) in a sudden cardiac arrest (SCA) patient, and to audibly/visually instruct an operator to enable it to activate defibrillation of the heart or allow the operator to decide when to activate defibrillation based on its electrocardiogram display. It is intended to be used by healthcare professionals (e.g., paramedics, medical staff) in healthcare settings. It consists of an external pulse generator (EPG) and skin-adhesive electrodes to monitor the rhythm/deliver the shocks; it has internal non-rechargeable batteries that must be replaced when indicated.


Environmental Conditions

  • Handling Environment Humidity - Percent (%) Relative Humidity
    • 95.00
    • 5.00
  • Handling Environment Temperature - Degrees Celsius
    • 50.00
    • -20.00
  • Special Storage Condition, Specify
    • Storage at extreme temperatures of -30C to 60C (-22F to 140F) is limited to 7 days. If storage at these temperatures exceeds one week, the electrode shelf-life is reduced.
  • Storage Environment Humidity - Percent (%) Relative Humidity
    • 95.00
    • 5.00
  • Storage Environment Temperature - Degrees Celsius
    • 25.00
    • 15.00

  • Device Sizes

    No Data Available


    Device Sterilization

    Device Sterile: False

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    Code: MKJ

    Device Name: Automated External Defibrillators (Non-Wearable)

    Device Class: 3

    Physical State: N/A

    Definition: This device is a non-wearable prescription use only aed. These are devices that include automated external defibrillation. Automated external defibrillators use external pad-type electrodes to sense, detect, classify and treat (with an electrical shock) ventricular fibrillation. These devices are intended to be used on suspected victims of sudden cardiac arrest. A person in cardiac arrest is unresponsive and is not breathing normally. The device can be sold with prescription only.

    Submission Type ID: 2

    Review Panel: CV

    Review Code: N/A

    Technical Method: N

    Gmp Exempt Flag: N/A

    Life Sustain Support Flag: N

    Unclassified Reason: N/A

    Implant Flag: N

    Target Area: N/A

    Regulation Number: 870.5310

    Third Party Flag: N

    Medical Specialty: CV


    Device Identifiers

    Device Id: 00885074630472

    Device Type: Previous

    DeviceId Issuing Agency: GS1

    Contains DI Number: N/A

    Package Quantity: N/A

    Package Discontinue Date: N/A

    Package Status: N/A

    Package Type: N/A


    Device Id: 00883873815434

    Device Type: Primary

    DeviceId Issuing Agency: GS1

    Contains DI Number: N/A

    Package Quantity: N/A

    Package Discontinue Date: N/A

    Package Status: N/A

    Package Type: N/A


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