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510(k) Data Aggregation

    K Number
    K103825
    Device Name
    V-GO INSULIN DELIVERY SYSTEM
    Manufacturer
    VALERITAS, INC.
    Date Cleared
    2011-02-23

    (55 days)

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

    VALERITAS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The V-Go Disposable Insulin Delivery Device is indicated for continuous subcutaneous infusion of insulin in one 24hour time period and on-demand bolus dosing in 2-Unit increments (up to 36 Units per one 24-hour time period) in adult patients requiring insulin. Specific basal rates are indicated for each model: V-Go 20 (20 Units/day or 0.83U/hr), V-Go 30 (30 Units/day or 1.25U/hr), and V-Go 40 (40 Units/day or 1.67U/hr).
    Device Description
    The Valeritas V-Go Disposable Insulin Delivery Device is a mechanical (no electronics), self-contained, sterile, patient fillable, single-use disposable insulin infusion device with an integrated stainless steel subcutaneous needle. It is designed for the subcutaneous infusion of insulin for the management of diabetes mellitus in persons requiring insulin. After filling the V-Go with insulin using the EZ Fill, the device is secured to the patient's skin over the infusion site with an adhesive backed foam pad. Once activated, the V-Go delivers a continuous infusion of insulin at a fixed rate. The device also allows the user to initiate bolus injections. Three device models (20, 30 and 40 Units/day) will be available. A window in the top of the pump allows the user to see into the reservoir to check the drug and to monitor the progress of the infusion.
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