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510(k) Data Aggregation

    K Number
    K946168
    Device Name
    IVAC ENTERAL ADMIN. SETS, IVAC INFUSION PUMPS
    Manufacturer
    Date Cleared
    1996-03-21

    (458 days)

    Product Code
    Regulation Number
    880.5725
    Why did this record match?
    Applicant Name (Manufacturer) :

    IVAC CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The intended use for the IVAC enteral administration sets is to provide nutrition to patients who have an impaired ability to orally ingest their food. The pumping segment or cassette of the enteral administration set interacts with the pumping mechanism of the infusion pump to regulate fluid flow at the desired rate.
    Device Description
    The IVAC enteral administration sets (Series 28XXX, 28XX6, 52XXX, 52XX6, 59XXX, 59XX6) incorporate standard IVAC set components and materials. The sets include an enteral adapter and. with some configurations, a pre-attached bag which holds the enteral formula during delivery. The enteral adapter is incompatible with standard ANSI IV set luers which prevents the user from accidentally attaching the enteral adapter to an intravenous set. The infusion pumps regulate fluid flow at the desired rate.
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