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    K Number
    K142483
    Device Name
    TurboSEAL Nasogastric Aspiration Tube
    Manufacturer
    TurboSEAL, L.P.
    Date Cleared
    2014-12-19

    (106 days)

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

    TurboSEAL, L.P.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The TurboSEAL™ Nasogastric Aspiration Tube (NGAT) is intended for gastric lavage and the administration of nutritional supplements through the distal tube port. It is also indicated for the aspiration of refluxed gastric fluid from the distal esophageal aspiration areas.
    Device Description
    The TurboSEAL™ Nasogastric Aspiration Tube (NGAT) is a typical Nasogastric Tube (NGT) allowing for enteral feeding, gastric decompression and gastric lavage. Connection of the device to standard hospital suction enables the application of suction to two separate locations (the Distal and Proximal Aspiration Areas) located at the distal end of the device. Aspiration at these sites allows for the removal of gastric fluid that has entered the esophaqus. Aspiration is limited to one aspiration site at a time, for a maximum duration of 5 hours at each site.
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