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510(k) Data Aggregation

    K Number
    K201418
    Device Name
    Sunset Heated CPAP Tube
    Manufacturer
    Sunset Healthcare Solutions, Inc.
    Date Cleared
    2021-01-29

    (245 days)

    Product Code
    BZE
    Regulation Number
    868.5270
    Why did this record match?
    Applicant Name (Manufacturer) :

    Sunset Healthcare Solutions, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Sunset Heated CPAP Tube is a heated wire breathing tube intended to provide warmed and/or humidified breathing gases before they enter a patient's airway. It is indicated for single-patient reuse in the home and in clinical settings, such as hospitals, institutions, sleep laboratories, and sub-acute care facilities. It may be used with non-invasive ventilation for adult patients. It is compatible with the Philips Respironics System One Heated Humidifier and Philips Respironics Dreamstation Heated Humidifier.
    Device Description
    The Sunset Heated CPAP Tube warms air, or breathable gas, as it travels to and from the respiratory patient along the breathing circuit of a respiratory system. It reduces condensation that can form in breathing circuit. The Sunset Heated CPAP Tube has a proprietary connector with two locking tabs that makes it compatible with the Respironics System One and with the Respironics Dreamstation series.
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