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510(k) Data Aggregation

    K Number
    K112915
    Device Name
    SPIRTIUS CUFF INFLATION SYRINGE
    Date Cleared
    2012-05-25

    (235 days)

    Product Code
    Regulation Number
    868.5750
    Why did this record match?
    Applicant Name (Manufacturer) :

    SPIRITUS TECHNOLOGIES LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The SCIS will be used to inflate to 25±2 cmH2O the cuff of a high-volume, low-pressure endotracheal tube that has been intubated by a trained medical professional.
    Device Description
    The Spiritus Cuff Inflation Syringe (SCIS) is a disposable syringe that will initially inflate the cuff on an endotracheal tube (ETT) to a pressure of 79 cmH2O ± an average standard deviation of 9 cmH2O to create a proper seal with the patients trachea and then automatically decrease the pressure in the cuff to a final pressure of 25cm H2O ± an average standard deviation of 2 cmH2O. The SCIS is designed in the form of a syringe to reflect current practice of using a syringe to inflate the cuff. The device is made of medical grade ISO approved plastic material. The SCIS is intended as a single patient use disposable device.
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