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510(k) Data Aggregation

    K Number
    K160503
    Device Name
    Vented Vial Adapter Transfer Device - 13mm
    Manufacturer
    MEDIMOP MEDICAL PROJECTS LTD.
    Date Cleared
    2016-05-04

    (70 days)

    Product Code
    LHI
    Regulation Number
    880.5440
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDIMOP MEDICAL PROJECTS LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Vented Vial Adapter Transfer Device is intended for the transfer and mixing of drugs contained in a vial.
    Device Description
    The proposed device, Vented Vial Adapter Transfer Device - 13mm, is intended for use in healthcare facilities or in home environment by the patient or care-giver to aid and support prescribed treatment and therapy. The proposed device consists of two integrated parts, the 13mm vial adapter body intended to be attached to a standard 13 mm drug vial. The other end is intended to be connected to a Female Luer connection. The vial adapter body contains the dual lumen piercing spike and the second part of the device is an assembled 0.2um hydrophobic air path filter (100% expanded PTFE membrane over Non-woven polyester membrane support). This enables keeping an equilibrium pressure between the drug vial and the ambient pressure, filtering the inserted/ released air through 0.2um air filter. The proposed device does not contain any medicinal substances.
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