Product Overview

N/A - CEDTC100


Device Description

A collection of noninvasive devices intended to conduct electrical signals from a patient's heart, via an electrode attached to the surface of the chest/limbs, to an electrocardiograph (ECG) machine or a patient monitoring system. It is designed as an insulated wire(s), which may additionally include a detachable or permanently attached electrode and/or cable with connector. Some types may be designed as a pre-configured array to assist electrode placement. This is a previously used single-use device that has been processed for an additional single-use patient application.


Environmental Conditions

No Data Available


Device Sizes

  • Length: 8.2 Feet
    • Length: 8.2 Feet


    Device Sterilization

    Device Sterile: True

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    Code: IKD

    Device Name: Cable, Electrode

    Device Class: 2

    Physical State: N/A

    Definition: N/A

    Submission Type ID: 4

    Review Panel: PM

    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: 890.1175

    Third Party Flag: N

    Medical Specialty: PM


    Device Identifiers

    Device Id: 57613327643232

    Device Type: Package

    DeviceId Issuing Agency: GS1

    Contains DI Number: 07613327643237

    Package Quantity: 1

    Package Discontinue Date: N/A

    Package Status: In Commercial Distribution

    Package Type: case


    Device Id: 07613327643237

    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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