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510(k) Data Aggregation

    K Number
    K122686
    Device Name
    ACCU-CHEK ULTRAFLEX INFUSION SET
    Date Cleared
    2012-11-16

    (73 days)

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

    ROCHE DIABETES CARE AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The ACCU-CHEK® Ultraflex is an infusion set for the subcutaneous infusion of insulin administered with microdosage insulin pumps.
    Device Description
    The ACCU-CHEK Ultraflex is an ethylene oxide sterilized, single-use, disconnectable infusion set with soft cannula perpendicular to the adhesive, for transfusion of insulin into the subcutaneous tissue. The infusion set includes a stainless steel introducer needle to facilitate insertion of the soft cannula into the dermis. The unit is designed to interface with commercially available insulin infusion pumps with suitable luer connections. The insulin infusion pump systems are designed to control the delivery of U100 insulin as prescribed by a health care professional. The system (infusion set, insulin infusion pump, and insulin) is indicated for patients with insulin dependent diabetes mellitus.
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