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510(k) Data Aggregation

    K Number
    K092905
    Device Name
    AUTOSTART BURETTE
    Manufacturer
    Date Cleared
    2010-03-04

    (164 days)

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

    ANALYTICA PTY LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Administration of fluids from a container to a patient's vascular system through a cannula inserted into a vein.
    Device Description
    The AutoStart Burette is an in-line burette used for intravenous administration of fluids (either gravitational or via an infusion pump) from a container to a patient's vascular system through a cannula inserted into a vein. This is a sterile, single-use device. The device is fitted with a float system which that allows the primary infusion to restart following addition to and dispensation of medication from the burette. There is no need to manually restart the infusion as is the case with conventional in-line burettes.
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