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    K Number
    K251812
    Device Name
    Steripath® Flow™ Blood Collection System
    Manufacturer
    Magnolia Medical Technologies
    Date Cleared
    2025-09-25

    (105 days)

    Product Code
    JKA
    Regulation Number
    862.1675
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Steripath® Flow™ Blood Collection System is a system to draw blood for in vitro diagnostic testing.

    The Steripath® Flow™ Blood Collection System is indicated for use as a blood collection system that diverts and sequesters the initial specimen prior to collection of a subsequent test sample to reduce the frequency of blood culture contamination when contaminants are present in the initial blood sample compared to blood cultures drawn with standard procedure without manual diversion.

    Additionally, components of the system may be used for infusion following sample collection after disconnection of the Initial Specimen Diversion Device® (ISDD®).

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