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510(k) Data Aggregation

    K Number
    K113683
    Device Name
    LIFESHIELD VISION INFUSION SET WITH PRE-PIERCED RESEAL
    Manufacturer
    HOSPIRA,INC.
    Date Cleared
    2012-01-12

    (28 days)

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

    HOSPIRA,INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    LIFESHIELD™ VISION™ Infusion sets are intended for the delivery of fluids including but not limited to blood and blood products from a container into a patients vascular system.
    Device Description
    The LIFESHIELD™ VISION™ infusion sets, are intended for use as gravity sets or with dedicated Hospira Infusion Pumps. These devices are obtainable in custom lengths and component options according to facility needs and physician preference, Hospira infusion sets are disposable devices for single patient use, which incorporate various set configurations and components. The components include Pre-pierced access ports (Pre-pierced Male Adapter Plug, Pre-pierced Y-site, and Pre-pierced T-connector) which are the subject of this submission, may be shared across Hospira set families may be used with sets for
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