Single-Patient-Use ECG Leadwire Set 5-LEAD, SNAP, AHA, 100 cm/39 in


Product Overview

Single
Multi-Link - 2052104-006


Device Description

A collection of non-sterile, noninvasive devices intended to be used 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 includes an insulated metal wire(s) with a detachable or permanently attached electrode, and may include a cable with connector; some types may be designed as a pre-configured array to assist electrode placement. It is not designed with radiolucent properties. This is a single-use device.


Environmental Conditions

  • Storage Environment Humidity - Percent (%) Relative Humidity
    • 95.00
    • 5.00
  • Storage Environment Temperature - Degrees Fahrenheit
    • 158.00
    • -22.00

  • Device Sizes

    No Data Available


    Device Sterilization

    Device Sterile: False

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    Code: DSA

    Device Name: Cable, Transducer And Electrode, Patient, (Including Connector)

    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: 870.2900

    Third Party Flag: Y

    Medical Specialty: CV


    Device Identifiers

    Device Id: 20885403252065

    Device Type: Package

    DeviceId Issuing Agency: GS1

    Contains DI Number: 10885403252068

    Package Quantity: 10

    Package Discontinue Date: N/A

    Package Status: In Commercial Distribution

    Package Type: Box


    Device Id: 10885403252068

    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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