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510(k) Data Aggregation

    K Number
    K193528
    Device Name
    Empty EVA Bag
    Manufacturer
    Haemotronic, Spa
    Date Cleared
    2020-07-22

    (216 days)

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

    Haemotronic, Spa

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Empty EVA Bag is an empty container used for administration of TPN (Total Parenteral Nutrition) 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 device is an empty flexible container (bag) in EVA material (Ethylene-vinyl acetate), that is to be filled up before use and intended for the administration of intravenous infusion solutions (TPN-Total Parenteral Nutrition). The bag is provided with three tubes necessary for the filling of the bag itself and the administration of the solution to the patient. The empty bag is filled by connecting it to containers (generally glass bottles) containing one or more solutions. The filling is done by the tube with the big bore connector where the non-re-opening clamp is located. After filling, the bag is clamped by means of non-re-opening clamp ad closed with the sealing cap (screwed cap), to secure the contents prior to administration. To make the fluid outflow from the bag towards the patient, the bag is connected to an intravascular administration set via the access port (spike port). When the bag is already filled, other medications can be added using the second access port (injection port). The device will be available in multiple containment volumes ranging from 250mL to 5000mL.
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