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The V-Go Disposable Insulin Delivery Device is indicated for continuous subcutaneous infusion of 20 Units of insulin in one 24hour time period (0.83U/hr) and on-demand bolus dosing in 2-Unit increments (up to 36 Units per one 24-hour time period) in adult patients requiring insulin. The V-Go 30 Disposable Insulin Delivery Device is indicated for continuous subcutaneous infusion of 30 Units of insulin in one 24hour time period (1.25U/hr) and on-demand bolus dosing in 2-Unit increments (up to 36 Units per one 24-hour time period) in adult patients requiring insulin. The V-Go 40 Disposable Insulin Delivery Device is indicated for continuous subcutaneous infusion of 40 Units of insulin in one 24hour time period (1.67U/hr) and on-demand bolus dosing in 2-Unit increments (up to 36 Units per one 24-hour time period) in adult patients requiring insulin.

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 adhesivebacked foam pad, which is attached to the back of the pump. 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 to supplement their daily basal insulin requirements. Three device models (20, 30 and 40 Units/day) will be available to address the different basal and bolus requirements of each patient. 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.