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510(k) Data Aggregation

    K Number
    K163586
    Device Name
    Trovita Health Science Safe-T Feed Ready-to-Feed Pouch with ENFit Connector
    Manufacturer
    TrovRx, Inc. dba Trovita Health Science
    Date Cleared
    2017-03-17

    (87 days)

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

    TrovRx, Inc. dba Trovita Health Science

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Trovita Health Science Safe-T Feed™ Ready-to-Feed Pouch with ENFit® Connector is intended to deliver liquid nutrition formula to an enteral access device (a feeding tube).
    Device Description
    The Trovita Health Science Safe-T Feed™ Ready-to-Feed Pouch with ENFit® Connector consists of a foil pouch with an integrated female ENFit® connector at one end and a hanging ring at the other. A silicone valve is mounted in the inner lumen of the connector to reduce the risk of formula leakage. The outer lumen (spout) of the ENFit® connector is covered with a foil tamperevidence seal. The pouch is designed such that it can be provided pre-filled with Trovita Health Science acidified liquid nutrition formula for tube feeding.
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