COVER EPG 53922US 3 PK MKT US


Product Overview

COVER EPG 53922US 3 PK MKT US
NA - 53922US


Device Description

A non-sterile device, typically made of disposable transparent plastic, intended to be attached over the control panel of a pacemaker external pulse generator (EPG) to form a protective enclosure to help prevent accidental changes to the EPG control settings. This is a single-patient device intended to be used for the duration of the treatment (single-use) before being discarded.


Environmental Conditions

  • Storage Environment Humidity - Percent (%) Relative Humidity
    • 95.00
    • 10.00
  • Storage Environment Temperature - Degrees Fahrenheit
    • 158.00
    • -40.00

  • Device Sizes

    No Data Available


    Device Sterilization

    Device Sterile: False

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    Code: DTE

    Device Name: Pulse-Generator, Pacemaker, External

    Device Class: 2

    Physical State: N/A

    Definition: N/A

    Submission Type ID: 1

    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: 870.3600

    Third Party Flag: N

    Medical Specialty: CV


    Device Identifiers

    Device Id: 00643169305120

    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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