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510(k) Data Aggregation

    K Number
    K022558
    Device Name
    NGT
    Date Cleared
    2003-07-08

    (340 days)

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

    MEDICAL INNOVATIVE PRODUCTS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The NGT is intended for gastric decompression, gastric suction, administration of nutritional supplements and medication, and to monitor core temperature.
    Device Description
    The NGT Nasogastric Tube is made of a plastic material, contains three lumens, a main suction lumen, a smaller vent lumen, and a still smaller temperature thermistor lumen. The primary suction lumen is used for drainage, the second vent lumen provides an air inlet as a mechanism to break suction minimizing the potential for tube blockage secondary to mucosal tissue invagination into the side holes of the primary lumen. The device is intended to be used with a standard suction source to facilitate drainage.
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