EEG Sensor Adult


Product Overview

EEG Sensor Adult
RD SedLine - 4248


Device Description

A small unit dedicated to detect and record the electrical activity of the brain in the form of an electroencephalogram (EEG). The electrical activity of the brain is detected via electrodes affixed to the patient's forehead or scalp. It is designed to operate as part of a patient monitoring system enhancing the function of this system (the parent device). The module automatically plugs into the parent device when the user places it into a standardized slot in the parent device which operates as a mainframe computer displaying the signals measured and provided by this module. It may also register auditory evoked potentials (AEP) signals.


Environmental Conditions

  • Handling Environment Humidity - Percent (%) Relative Humidity
    • 95.00
    • 5.00
  • Handling Environment Temperature - Degrees Celsius
    • 32.00
    • 10.00
  • Storage Environment Humidity - Percent (%) Relative Humidity
    • 95.00
    • 5.00
  • Storage Environment Temperature - Degrees Celsius
    • 32.00
    • 10.00

  • Device Sizes

    No Data Available


    Device Sterilization

    Device Sterile: False

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    Code: GXY

    Device Name: Electrode, Cutaneous

    Device Class: 2

    Physical State: N/A

    Definition: N/A

    Submission Type ID: 1

    Review Panel: NE

    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: 882.1320

    Third Party Flag: Y

    Medical Specialty: NE


    Device Identifiers

    Device Id: 10843997011775

    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: 00843997011778

    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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