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510(k) Data Aggregation

    K Number
    K190414
    Device Name
    Moss Gastrostomy Tube, Moss Nasal Tube – Mark IV
    Manufacturer
    Moss Tubes, Inc.
    Date Cleared
    2019-06-14

    (113 days)

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

    Moss Tubes, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Moss Gastrostomy Tube is used for gastric and proximal duodenal decompression plus duodenal feeding in adult populations. The Moss Nasal Tube is used for decompression and simultaneous feeding in adult populations.
    Device Description
    The 18", triple-lumen, 18FR Moss Gastrostomy Tube provides decompression while simultaneously feeding enterally. The suction channel supplements the gastric site with aspiration within the proximal duodenum. Multiple holes in the suction lumen are designed to prevent mucosal occlusion. The second bore delivers an elemental diet three inches farther downstream into the distal duodenum, utilizing an industry standard ENFit connector. Refluxing excess is automatically removed while still within the proximal duodenum. The third lumen inflates a gastric retention balloon. Each device is individually packaged, and sterilized by Ethylene Oxide. The 44", triple-lumen, 18FR Moss® Nasal Tube provides decompression while simultaneously feeding enterally. The suction channel supplements the aspiration within the distal esophagus and proximal duodenum. Multiple holes in the suction lumen prevent mucosal occlusion. The second bore delivers an elemental diet three inches farther downstream into the distal duodenum, utilizing an industry standard ENFit connector. Refluxing excess is automatically removed while still within the proximal duodenum. The third lumen inflates a gastric retention balloon at the esophagogastric junction. Each device is individually packaged, and sterilized by Ethylene Oxide.
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    K Number
    K990389
    Device Name
    MOSS GASTROSTOMY TUBE
    Manufacturer
    MOSS TUBES, INC.
    Date Cleared
    1999-03-22

    (42 days)

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

    MOSS TUBES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Used for gastric and proximal duodenal decompression plus duodenal feeding.
    Device Description
    Moss Gastrostomy Tube
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    K Number
    K984628
    Device Name
    MODIFICATION OF MOSS P.E.G. TRAY
    Manufacturer
    MOSS TUBES, INC.
    Date Cleared
    1999-03-17

    (77 days)

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

    MOSS TUBES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Moss P. E. G. Tray is used to place a tube through the abdominal wall and into the lumen of the stomach (and/or beyond) without open surgery. The procedure provides a channel for providing nourishment directly into the digestive system for patients who cannot swallow (e.g. after stroke). An independent channel can be suctioned to remove excess feedings, swallowed air, or other fluids that might distend the stomach and lead to vomiting.
    Device Description
    Not Found
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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?
    Applicant Name (Manufacturer) :

    MOSS TUBES, INC.

    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
    K984310
    Device Name
    MOSS TUBES, INC, ALL SILICONE GASTROSTOMY TUBE
    Manufacturer
    MOSS TUBES, INC.
    Date Cleared
    1999-02-24

    (84 days)

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

    MOSS TUBES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Used to feed nutrients directly into the stomach through a stoma in the abdomen. The tubes are intended as a replacement device and are labeled as such.
    Device Description
    Moss Tubes, Inc. All Silicone Gastrostomy Tube
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