EGM CABLE CEDTEGM100 DIAMONDTEMP US


Product Overview

EGM CABLE CEDTEGM100 DIAMONDTEMP US
DiamondTemp™ EGM cable - CEDTEGM100


Device Description

A non-patient-contact, insulated, electrical cord with a connector (plug) at both ends designed to transmit electrical power and/or signal (data) between medical devices (e.g., to connect a lead, electrical catheter, handpiece, or monitor to a parent device). It is not intended to connect directly to patient-worn electrodes (i.e., it is not a lead), is not intended to connect to the mains (i.e., not a mains power cable), does not generate any type of power and/or signal, and has no additional non-electrical conducting or processing functionality. This is a reusable device.


Environmental Conditions

  • Handling Environment Humidity - Percent (%) Relative Humidity
    • 90.00
    • 15.00
  • Handling Environment Temperature - Degrees Fahrenheit
    • 140.00
    • -22.00
  • Special Storage Condition, Specify
    • Keep dry
  • Storage Environment Temperature - Degrees Fahrenheit
    • 86.00
    • 59.00

  • Device Sizes

    No Data Available


    Device Sterilization

    Device Sterile: False

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    Code: OAE

    Device Name: Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation

    Device Class: 3

    Physical State: The device is an ablation catheter that features electrodes through which thermal energy is delivered.

    Definition: For the treatment of atrial fibrillation.

    Submission Type ID: 2

    Review Panel: CV

    Review Code: N/A

    Technical Method: N

    Gmp Exempt Flag: The ablation catheter delivers energy to the specific region of the heart in order to create lesions that will treat the patient of atrial fibrillation.

    Life Sustain Support Flag: Y

    Unclassified Reason: N/A

    Implant Flag: N

    Target Area: Heart

    Regulation Number: N/A

    Third Party Flag: N

    Medical Specialty: N/A


    Device Identifiers

    Device Id: 00763000455699

    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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