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    K Number
    K041152
    Device Name
    THINSET 1.8 ML RESERVOIR, MODEL 326A; THINSET 3.0 ML RESERVOIR, MODEL 332A
    Manufacturer
    APPLIED DIABETES RESEARCH, INC.
    Date Cleared
    2004-05-24

    (21 days)

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

    APPLIED DIABETES RESEARCH, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The THINSet 1.8 ml and 3.0 ml Reservoirs are indicated for use for the infusion of medicine, including insulin, from an external infusion pump. The reservoir is not intended for use with blood or blood products.
    Device Description
    The ThinSet Reservoir is a single use piston style syringe available with a capacity of 1.8 mil or 3.0 mil. It consists of a hollow barrel with a male Luer lock fitting at the distal end, and a plunger with o-rings. This device is designed to deliver medication, including insulin, subcutaneously. The male Luer lock fitting of the reservoir is placed in an external infusion pump. The ThinSet Reservoir comes with a 22 gauge cannula.
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