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510(k) Data Aggregation

    K Number
    K161800
    Device Name
    OnSite-IV
    Manufacturer
    Date Cleared
    2016-12-06

    (159 days)

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

    PHARMC, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The OnSite-IV™ is a single use sterile device for the preparation and / or transfer of drugs from a standard pharmaceutical vial into an elastomeric pump or IV bag.
    Device Description
    The OnSite-IV™ device is a sterile, single use device that, through the use of an integrated vial spike, facilitates creation of a sterile fluid path to transfer liquid from the syringe body to a standard pharmaceutical vial with a 20 mm cap containing a drug, in order to mix or reconstitute the drug and aspirate and transfer the prepared drug back into the syringe body for delivery into an IV bag or elastomeric pump. The device is intended to be used by health care professionals (HCPs) such as physicians, nurses and pharmacists in a clinical setting.
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