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510(k) Data Aggregation

    K Number
    K132424
    Device Name
    METRIXCARE
    Manufacturer
    THE METRIX COMPANY
    Date Cleared
    2014-02-12

    (191 days)

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

    THE METRIX COMPANY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is intended to deliver liquid nutritional formulas or water to a patient's enteral access device (feeding tube).
    Device Description
    The sets are constructed from flexible, medical grade, Non-DEHP tubing in various configurations with a stepped connector at one end. One configuration may include an Enteral solution container constructed of a laminate material with a stepped connector to connect to a gastric tube (or an extension set) or another configuration may simply be an administration set which connects the patient gastric tube to the nutrition liquid container.
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