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510(k) Data Aggregation

    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?
    Product Code :

    BSS

    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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    K Number
    K051480
    Device Name
    ENTERAL FEEDING TUBE
    Manufacturer
    BIOSEARCH MEDICAL PRODUCTS, INC.
    Date Cleared
    2005-10-12

    (131 days)

    Product Code
    BSS
    Regulation Number
    876.5980
    Why did this record match?
    Product Code :

    BSS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Indications for use would be when the patient cannot feed him/herself and cannot be fed by another person. This catheter would be placed Nasogastrically and nutrients supplied through catheter to the patient.
    Device Description
    Nasogastric Feeding Tube (4Fr, 6Fr, 10Fr and 12Fr; sterile and non-sterile)
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    K Number
    K984629
    Device Name
    MOSS TUBES, INC. NASAL TUBE - MARK IV
    Manufacturer
    MOSS TUBES, INC.
    Date Cleared
    1999-03-02

    (62 days)

    Product Code
    BSS
    Regulation Number
    876.5980
    Why did this record match?
    Product Code :

    BSS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Used for decompression and simultaneous internal feeding.
    Device Description
    Moss Tubes, Inc. Nasal Tube - Mark IV
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    K Number
    K961711
    Device Name
    ASPISAFE GASTRIC TUBE
    Manufacturer
    B. BRAUN MEDICAL, INC.
    Date Cleared
    1997-06-11

    (405 days)

    Product Code
    BSS
    Regulation Number
    876.5980
    Why did this record match?
    Product Code :

    BSS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use is for the prophylaxis of pulmonary aspirations during induction and termination of general anesthesia.
    Device Description
    The Aspisafe Gastric Tube is designed to be used for the prophylaxis of pulmonary aspiration during induction and termination of general anesthesia.
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