12‐lead high‐performance, multi‐channel, interpretative resting electrocardiograph which displays, acquires, prints and stores ECG tracings for adults and children. 4.3" display and 100mm printer paper.


Product Overview

12‐lead high‐performance, multi‐channel, interpretative resting electrocardiograph which displays, acquires, prints and stores ECG tracings for adults and children. 4.3" display and 100mm printer paper.
ECG100+ - ECG100+


Device Description

A device intended to be used by a healthcare professional in a clinical setting to acquire and process the electrical activity of the heart for digital display in the form of a graph, to assist a physician in assessing electrical cardiac physiology [electrocardiography (ECG)]. It is designed for recording the electrical signal from two or more configurations of electrodes (ECG-leads) at a time (multichannel) and may be intended for resting ECG and/or stress/exercise ECG. It will either include an integrated display or be designed to transmit ECG data to an off-the-shelf device for display; ECG electrodes may be included. Data interpretation and/or telemetry features might also be included.


Environmental Conditions

  • Handling Environment Atmospheric Pressure - KiloPascal
    • 106.00
    • 70.00
  • Handling Environment Humidity - Percent (%) Relative Humidity
    • 95.00
    • 20.00
  • Handling Environment Temperature - Degrees Celsius
    • 40.00
    • 10.00
  • Storage Environment Atmospheric Pressure - KiloPascal
    • 106.00
    • 70.00
  • Storage Environment Humidity - Percent (%) Relative Humidity
    • 95.00
    • 20.00
  • Storage Environment Temperature - Degrees Celsius
    • 40.00
    • 0.00

  • Device Sizes

    No Data Available


    Device Sterilization

    Device Sterile: False

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    Code: DPS

    Device Name: Electrocardiograph

    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: 870.2340

    Third Party Flag: Y

    Medical Specialty: CV


    Device Identifiers

    Device Id: 08056732653610

    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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