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510(k) Data Aggregation

    K Number
    K101412
    Device Name
    EVA TPN BAG
    Manufacturer
    VALMED S.R.L.
    Date Cleared
    2011-04-13

    (328 days)

    Product Code
    KPE
    Regulation Number
    880.5025
    Why did this record match?
    Applicant Name (Manufacturer) :

    VALMED S.R.L.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The EVA TPN bag is for use in compounding and storage of parenteral nutrition solutions prior to and during administration to a patient using an intravascular administration set.
    Device Description
    The EVA TPN bags are empty containers for use in compounding and storage of sterile medical solutions such as parenteral nutrition solutions prior to and during administration to a patient using an intravascular administration set. The empty bags are filled by connecting them to containers through standard spikes. A transfer set in different configurations, ranging from one-lead to three-lead sets, can be provided with the empty bag. The bags are clamped after filling by means of non-reopening clamps. Additional medications can be added to the container using a medication port. After filling, the containers can be attached to an intravascular administration set via the set port. The bags range in volume capacity from 150 mL to 5000 mL. The bag is discarded after use. The EVA TPN bags are made of a copolymer of ethylene and vinyl acetate. The tubings of the transfer set are made of a polyvinyl chloride material.
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