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510(k) Data Aggregation

    K Number
    K193088
    Device Name
    MaxZero Extension Sets with Needle-Free Connector(s)
    Manufacturer
    Carefusion, Inc.
    Date Cleared
    2020-10-23

    (352 days)

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

    Carefusion, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The MaxZero™ extension set with needle-free connector(s) is for single use only. The MaxZero™ extension set with needle-free connector(s) may be used for direct injection, intermittent infusion, continuous infusion or aspiration of drugs, blood and fluids.
    Device Description
    The MaxZero™ Extension Sets with Needle-Free Connector(s) are intravascular extension sets intended for single patient use, including pediatrics and immunocompromised patients, for direct injection, intermittent infusion continuous infusion or aspiration of drugs, blood and fluids. The MaxZero™ Extension Sets with Needle-Free Connector(s) are sterile single patient devices that can be used for up to seven (7) days and 200 activations. All extension sets included in this submission are not made from natural rubber latex or DEHP.
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