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510(k) Data Aggregation

    K Number
    K223683
    Device Name
    EnteraLoc Flow
    Manufacturer
    Vonco Products
    Date Cleared
    2023-07-10

    (214 days)

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

    Vonco Products

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Vonco Products EnteraLoc Flow spouted pouch with ENFit® Connector is indicated for use as a dispenser of enteral nutrition by way of direct connection to a feeding tube or extension set. It is intended to deliver nutrition into the gastrointestinal system of a patient. The pouch, once filled, is intended to be used in clinical or home care settings by users ranging from laypersons to clinicians, in all age groups.
    Device Description
    The Vonco Products EnteraLoc Flow spouted pouch with ENFit® Connector consists of a foil pouch with an integrated female ENFit® connector at one end. The EnteraLoc Flow pouch is provided with a tamper evident cap. The pouch is designed to be pre-filled with liquid nutrition formula for tube feeding. EnteraLoc Flow is a single use device. EnteraLoc Flow spouted pouch with ENFit® Connector is designed as a single use, over-the-counter device. The pouches will be available in a range of sizes, with a range of nutritional values (based upon the formula which the pouch is filled). Based upon the required nutritional intake requirements, the user will select the proper size pouch and quantity for feeding.
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    K Number
    K210971
    Device Name
    EnteraLoc Flow
    Manufacturer
    Vonco Products
    Date Cleared
    2021-08-18

    (140 days)

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

    Vonco Products

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The EnteraLoc Flow spouted pouch with ENFit® Connector is indicated for use as a dispenser of enteral nutrition by way of direct connection to a feeding tube or extension set. It is intended to deliver nutrition into the gastrointestinal system of a patient. The pouch, once filled, is intended to be used in clinical or home care settings by users ranging from laypersons to clinicians, in all age groups.
    Device Description
    The Vonco Products EnteraLoc Flow spouted pouch with ENFit Connector consists of a foil pouch with an integrated female ENFit connector at one end. The EnteraLoc Flow pouch is provided with a tamper evident cap. The pouch is designed to be pre-filled with liquid nutrition formula for tube feeding. The EnteraLoc Flow spouted pouch with ENFit Connector will be available in sizes ranging from 30mL - 1500mL dependent upon market and customer need.
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