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510(k) Data Aggregation

    K Number
    K173913
    Device Name
    MEDRAD® Imaging Bulk Package Transfer Set
    Manufacturer
    Bayer U.S. LLC
    Date Cleared
    2018-05-04

    (133 days)

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

    Bayer U.S. LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MEDRAD® Imaging Bulk Package Transfer Set (IBP Transfer Set) is indicated for the transfer of ULTRAVIST® (Iopromide), ISOVUE® (Iopamidol), and OMNIPAQUE™ (Iohexal) contrast media as supplied in an approved Imaging Bulk Package (IBP) presentation to empty sterile syringes on single-use only syringe-based contrast power injection systems indicated for the controlled, automatic venous administration of contrast agents for CT procedures. The Transfer Set is to be discarded after one of the following conditions has occurred first; the contrast media container has been depleted, the contrast media use time has expired, or 10 hours has elapsed since the container was penetrated.
    Device Description
    The MEDRAD ® Imaging Bulk Package Transfer Set is a pre-administration filling device that is designed to transfer fluid from an imaging bulk package into multiple sterile syringes via a powered injector system prior to a CT procedure. There is no direct patient contact with the use of this device. It is intended to spike one bulk package of iodinated contrast media only. Each imaging bulk transfer set consists of a spike, flexible tubing, and a swabbable valve. The transfer set is provided sterile, individually packaged, and is not intended to be resterilized.
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