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510(k) Data Aggregation

    K Number
    K180605
    Device Name
    GastroFlush
    Date Cleared
    2018-10-24

    (231 days)

    Product Code
    Regulation Number
    876.5980
    Why did this record match?
    Applicant Name (Manufacturer) :

    Bionix Development Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    GastroFlush is indicated for use in clearing occlusions/clogs from enteral feeding tubes placed for nutrition and/or decompression in adult or adolescent patients that have tube size 8Fr-24Fr and tube length no longer than 42 inches. It is intended to be used by or under the direction of a licensed physician.
    Device Description
    The GastroFlush device uses a pulsatile stream of pressurized water to gently dislodge and flush clogs from obstructed G-tubes, NG tubes and other tubes placed for the purposes of enteral nutrition and/or gastrointestinal decompression in the clinical or home setting. A series of connected one-way valves is used to ensure that the pressurized water flows in only the correct direction. Pressure relief valves with specified "cracking pressure" are used to ensure that overpressure of the system is avoided. Lastly, specialty connectors including the use of the new ENFit enteral feeding tube connectors conforming to ISO 80369-3 ensure against the inadvertent misconnection of the GastroFlush device to the clogged enteral tube, or the use of Luer syringes and/or similar devices in the attempt to unclog the enteral tube.
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