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510(k) Data Aggregation

    K Number
    K181393
    Device Name
    Empty Eva Bag, models FVM0134BP, FVM0135BP, FVM0136BP, FVM0137BP, FVM0138BP, FVM0139BP, FVM0140BP, FVM0141BP
    Manufacturer
    VALMED SRL
    Date Cleared
    2019-02-15

    (262 days)

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

    VALMED SRL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Empty EVA Bag is an empty container used for administration of intravenous solutions to the patient using an intravascular administration set. Medication transfer in and out of the container is done using aseptic technique.
    Device Description
    The Empty EVA Bag is an empty container used for administration of intravenous solutions to the patient using an intravascular administration set. Medication transfer in and out of the container is done using aseptic technique. The empty bags are filled by connecting them to containers - generally glass bottles closed by a pierceable membrane - containing one or more solutions through standard spikes and tubing. After filling, the transfer set is removed and the bags are clamped by means of inviolable clamps to secure the contents prior to their administration. To make the fluid outflow from the bag towards the patient, the container can be then attached to an intravascular administration set via the spike port and twist - off connector. When the bag is already filled, other medications can be added using the injection port. The bags range in volume capacity from 150 ml to 5000 ml. The device is sold sterile and cannot be re-used or re-sterilized; it is discarded after use. The Empty EVA Bag is intended for use by qualified staff.
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