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510(k) Data Aggregation

    K Number
    K083702
    Device Name
    TRACH-ASSIST
    Manufacturer
    MERGENET MEDICAL
    Date Cleared
    2009-03-05

    (80 days)

    Product Code
    BZA
    Regulation Number
    868.5810
    Why did this record match?
    Product Code :

    BZA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Trach-Assist is an airway connector intended to connect between an endotracheal tube or tracheostomy tube and the ventilator circuit or closed suction system. It can assist in removal of patient secretions that may collect in ventilatory tubing.
    Device Description
    Trach-Assist is a simple connector with standard 15 mm fittings permitting connection with an endotracheal tube or tracheostomy tube and the patient wye of a breathing circuit. The Trach-Assist H has a port for insertion of a suction catheter to remove secretions while Trach-Assist-I uses Closed Suction Catheter system to remove secretions.
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