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510(k) Data Aggregation

    K Number
    K090759
    Device Name
    BIODRAIN STREAMWAY FLUID MANAGEMENT SYSTEM
    Date Cleared
    2009-04-01

    (9 days)

    Product Code
    Regulation Number
    878.4780
    Why did this record match?
    Applicant Name (Manufacturer) :

    BIODRAIN MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The BioDrain STREAMWAY™ Fluid Management System (FMS) is intended to be used in areas such as Operating Rooms, Intensive Care Units, Pathology Suites, Emergency Rooms, Surgical Centers and Doctors' Offices to collect and dispose of fluid waste.
    Device Description
    The BioDrain STREAMWAY™ FMS system has been designed to safely remove surgical fluid waste during a surgical procedure. The device is wall mounted in the room in which the procedure is being conducted. It is connected to the hospital/clinic vacuum line system, the hospital/clinic drain system, and electrical power. The device removes waste via a disposable suction tube (not provided with system) from the patient and surrounding area, measures the volume of fluid collected, and disposes of the waste into the hospital drainage system. The device has a self cleaning cycle to clean the internal mechanism of the device. The cleaning solution container and the suction tube to the operative field are disposable. The cleaning solution adapter is reusable.
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