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510(k) Data Aggregation

    K Number
    K132759
    Device Name
    VENTRAIN
    Date Cleared
    2014-03-26

    (203 days)

    Product Code
    Regulation Number
    868.5925
    Why did this record match?
    Applicant Name (Manufacturer) :

    DOLPHYS MEDICAL B.V.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    For emergency ventilation via a small lumen transtracheal catheter, in case conventional ventilation by mask and/or a large-bore endotracheal tube cannot be performed. Ventilation is accomplished by manual, intermittent ventilation with oxygen through the catheter for subsequent lung inflation and deflation.
    Device Description
    Ventrain is a manually operated ventilation device that provides adequate ventilation through a narrow-bore transtracheal catheter, even in case of a completely obstructed upper airway. Ventrain is specifically designed for 'cannot intubate, cannot ventilate' emergencies where conventional ventilation by mask and/or large-bore endotracheal tube cannot be performed. Ventrain consists of a handheld unit for manual control of gas flow to the patient. One side of the handheld is connected with an oxygen supply, such as an oxygen cylinder. The other side of the handheld is connected to a transtracheal catheter inserted in the patient. The handheld contains a polymer manifold for channeling the gas flow through the device. The user controls ventilation by opening or closing holes in the manifold with the thumb and index finger. Ventrain is capable of actively removing gas from the lungs in the expiration phase by suction (Expiratory Ventilation Assistance). Therefore, Ventrain can also be used for patients with a complete upper airway obstruction
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