Philips Single-Patient-Use Disposable ECG Lead Sets are intended for use only by trained healthcare professionals for measurement of a patients ECG for both diagnostic and monitoring purposes. Use is limited by the indications for use of the connected monitoring or diagnostic equipment. These Philips lead sets are intended for short-term use only (average patient stay of 5 days). Average lifetime of 5 days for disposable products.


Product Overview

Philips Single
ECG Electrodes - 5 LEADS SET DISPOSABLE, BEDSIDE IEC RD


Device Description

A collection of 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 (e.g., EEG belt) to assist electrode placement. This is a reusable device.


Environmental Conditions

  • Storage Environment Atmospheric Pressure - KiloPascal
    • 108.00
    • 10.00
  • Storage Environment Humidity - Percent (%) Relative Humidity
    • 95.00
    • 0.00
  • Storage Environment Temperature - Degrees Celsius
    • 70.00
    • -40.00
  • 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: 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: 20884838075737

    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


    Device Id: 00884838075733

    Device Type: Unit of Use

    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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