Wearable Biosensor - ECG Remote Monitoring Biosensor


Product Overview

Wearable Biosensor
Advance Biometrix - AB1251


Device Description

An electrically-powered, noninvasive device designed to be worn by a patient during daily activities for 24-hour recording of the electrocardiographic signals of the heart, for the diagnosis of cardiac disorders (e.g., arrhythmias). The recorded measurements can be downloaded and analysed at a medical facility, typically using a computer with a dedicated software. Otherwise known as a Holter monitor, the device typically incorporates display and controls, and may include surface electrodes, lead wires and accessories intended for attachment/removal (e.g., wipes, adhesive remover).


Environmental Conditions

  • Handling Environment Humidity - Percent (%) Relative Humidity
    • 90.00
    • 10.00
  • Handling Environment Temperature - Degrees Celsius
    • 45.00
    • 0.00
  • Special Storage Condition, Specify
    • For long-term storage of more than 30 days, maintain between 10 and 27 Degrees Celsius
  • Storage Environment Humidity - Percent (%) Relative Humidity
    • 90.00
    • 10.00
  • Storage Environment Temperature - Degrees Celsius
    • 45.00
    • 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: DRG

    Device Name: Transmitters And Receivers, Physiological Signal, Radiofrequency

    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: 870.2910

    Third Party Flag: Y

    Medical Specialty: CV


    Code: MWJ

    Device Name: Electrocardiograph, Ambulatory (Without Analysis)

    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: 870.2800

    Third Party Flag: N

    Medical Specialty: CV


    Device Identifiers

    Device Id: B353AB12512

    Device Type: Package

    DeviceId Issuing Agency: HIBCC

    Contains DI Number: B353AB12511

    Package Quantity: 25

    Package Discontinue Date: N/A

    Package Status: In Commercial Distribution

    Package Type: Small Box


    Device Id: B353AB12511

    Device Type: Primary

    DeviceId Issuing Agency: HIBCC

    Contains DI Number: N/A

    Package Quantity: N/A

    Package Discontinue Date: N/A

    Package Status: N/A

    Package Type: N/A


    Device Id: B353AB12513

    Device Type: Package

    DeviceId Issuing Agency: HIBCC

    Contains DI Number: B353AB12512

    Package Quantity: 8

    Package Discontinue Date: N/A

    Package Status: In Commercial Distribution

    Package Type: Big Box


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