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510(k) Data Aggregation

    K Number
    K212530
    Device Name
    IVX Fluid Transfer Set
    Manufacturer
    Date Cleared
    2022-04-24

    (256 days)

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

    Omnicell, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The IVX Fluid Transfer Set is a single use device indicated for use with the IVX Station Pharmacy Compounding System. The IVX Fluid Transfer device contains three separate tubing configurations and is indicated for the following applications: - Aseptic withdraw of fluid from I.V. bag(s) in preparation for compounding, - aseptic reconstitution of lyophilized drug in vial(s) from an I.V. bag source and - aseptic transfer of fluid from an I.V. bag of compounded drug into a final container(s) for use in the preparation of final compounded drugs for patient infusion administration.
    Device Description
    The IVX Fluid Transfer Set is a sterile, single-use fluid transfer tubing set that contain three separate tubing configurations, Withdraw Transfer Set, Reconstitution Transfer Set and Stock Solution Transfer Set. - The Withdraw Transfer Set is used to remove excess fluid from an I.V. bag and place the fluid in a waste container for disposal. - The Reconstitution Transfer Set is used to withdraw fluid from an I.V. bag and transfer the fluid to a vial that contains powdered drug so that the drug can be reconstituted. - The Stock Solution Transfer Set is used to transfer fluid from an I.V. bag of a compounded drug into a final container, which is a syringe. Each process is performed using aseptic technique within the ISO 5 environment using the IVX Pharmacy Compounding Station. The IVX Fluid Transfer Set is intended to be used by trained healthcare personnel and is not intended to be used for direct patient contact.
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