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510(k) Data Aggregation

    K Number
    K120395
    Device Name
    NERIA MULTI SUBCUTANEOUS INFUSION SET
    Date Cleared
    2012-05-30

    (112 days)

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

    UNOMEDICAL DEVICES S.A DE C.V

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The sets are indicated for the infusion of fluids into the body below the surface of the skin when attached to a fluid reservoir. These neria™ multi sets are intended to be used by patients of all ages who have been prescribed subcutaneous infusion of immunoglobulin (IgG) for the treatment of Primary Immunodeficiency Disease (PID).
    Device Description
    The neria™ multi product is a multisite infusion catheter. The product has a luer lock connector that is designed to be attached to an infusion pump reservoir. The tubing from the luer connector is attached to a furcation or splitter block, which splits the fluid flow into two, three or four subcutaneous Infusion catheters. Each tube that exits the splitter terminates in a subcutaneous catheter with a stainless steel infusion needle set at 90 degrees from an adhesive pad. The neria™ multi line will include three different needle lengths of 8, 10 and 12 mm. The product is provided with a separate tubing clamp or clamps to enable the user to selectively stop infusion to one or more sites as necessary. The sets are packaged in custom formed blisters sealed with a Sterikraft paper lid and sterilized in a validated EO gas cycle.
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