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510(k) Data Aggregation

    K Number
    K201415
    Device Name
    Vial2Bag Advanced 20mm Admixture Device
    Manufacturer
    West Pharmaceutical Services AZ, Inc.
    Date Cleared
    2020-10-21

    (145 days)

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

    West Pharmaceutical Services AZ, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Vial2Bag Advanced™ 20mm Admixture Device is indicated to serve as a connection between a 50, 100 or 250mL IV bag, vial with 20mm closure, and an external IV administration set. The integrated Vial Adapter makes it possible to reconstitute and/or admix drugs prior to administration to the patient.
    Device Description
    The Vial2Bag Advanced [M 20mm Admixture Device is a single use, fluid transfer device that allows for the reconstitution and transfer of fluids from drug vials into the IV bag containing infusion solution, through the IV bag administration port. The device consists of the body, Protector, IV Port, and an integrated vial adapter. The device is provided as a sterile, non-pyrogenic product. The device is intended to be used with standard drug vials with a seal diameter of 20mm and an elastomeric stopper. The Vial2Bag Advanced1™ 20mm Admixture Device is designed to work with a standard 50, 100, or 250mL IV bag and an external IV administration set. The device is limited to a single device configuration. Users should not attach a Vial2Bag Advanced™ 20 mm Admixture Device to another Vial2Bag Advanced™ 20mm Admixture Device. The device does not contain any medicinal substances and there are no additional accessories needed or provided with the Vial2Bag Advanced™ 20mm Admixture Device for the device to meet its intended purpose.
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