Alice 6 LDxN Headbox, International and Brazil


Product Overview

Alice 6 LDxN Headbox, International and Brazil
Alice 6 - Alice 6 LDxN Headbox, INTL and Brazil


Device Description

A mains electricity (AC-powered) device designed to record physiological signals from a sleeping patient to assess sleep disorders (e.g., insomnia, snoring or sleep apnoea). The device is typically computerized and usually records an electrocardiogram (ECG), electroencephalogram (EEG), chest wall motion, airflow at both the nose and the mouth, eye movements, haemoglobin oxygen saturation (SpO2) and electromyogram (EMG). Parameters may be added or omitted depending on the study being performed. The device includes multiple electrodes/sensors placed on the patient in specific areas as well as amplifiers and filters for recording.


Environmental Conditions

  • Storage Environment Humidity - Percent (%) Relative Humidity
    • 95.00
    • 15.00
  • Storage Environment Temperature - Degrees Celsius
    • 60.00
    • -20.00
  • Storage Environment Temperature - Degrees Fahrenheit
    • 140.00
    • -4.00

  • Device Sizes

    No Data Available


    Device Sterilization

    Device Sterile: False

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    Code: OLV

    Device Name: Standard Polysomnograph With Electroencephalograph

    Device Class: 2

    Physical State: May include standard polysomnography recording hardware (e.g. headbox, cables, computer, monitor, wireless) and basic software (e.g. used to display, store, archive, or manually annotate data). Does NOT include electrodes, vital signs monitors, polysomnography devices without electroencephalograph, more complex software used to analyze electroencephalograph data or software used to automatically detect events.

    Definition: Acquire, display, store, and archive electroencephalographic signals from the brain and other signals (such as electromyography, respiratory and/or oximetry signals) for sleep recordings. May also be used to allow on-screen review, user-controlled annotation and user-controlled marking of data.

    Submission Type ID: 1

    Review Panel: NE

    Review Code: N/A

    Technical Method: N

    Gmp Exempt Flag: Uses electrodes placed on the scalp, within the brain, or other locations, via user-specified locations, to record and display electrical activity of the brain and other organs

    Life Sustain Support Flag: N

    Unclassified Reason: N/A

    Implant Flag: N

    Target Area: Brain

    Regulation Number: 882.1400

    Third Party Flag: Y

    Medical Specialty: NE


    Device Identifiers

    Device Id: 00606959028623

    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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