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The Asante Snap Insulin Pump System is indicated for continuous delivery of insulin at programmable basal and bolus rates for the management of diabetes mellitus in adult patients requiring insulin.

The Snap™ Insulin Pump System is a wearable, continuous, programmable insulin delivery system. It is a portable, battery-powered system capable of delivering insulin at fixed and variable rates. The Snap system consists of the following components and accessories: - 1. a software-controlled, programmable, reusable Controller module; - 2. a single-use, disposable Pump Body; - 3. an Unomedical Asante Comfort™ or Asante Conset™ Infusion Set (K120872), or an equivalently FDA-cleared infusion set with Luer fitting using the Asante sterile, single-use disposable Infusion Set Adapter; and - 4. accessories, including the AsanteSync™ download cradle with USB cable, and a fabric Case and plastic Clip that provide a means of attaching the Snap system to the user's belt or other clothing. The Controller module has a user interface to program delivery parameters for basal and bolus insulin delivery and the Pump Body provides the drive mechanism and battery power and holds the pre-filled insulin cartridges. The user obtains Eli Lilly Humalog fast-acting U100 insulin from their pharmacy and inserts the pre-filled glass cartridge into the Asante Pump Body. The Pump Body is connected to the Controller module and either (a) an Unomedical Asante Comfort or Asante Conset infusion set with proprietary connector, or (b) an Asante Infusion Set Adapter with Luer fitting that connects to commercially available Luered infusion sets to allow delivery of insulin for the management of diabetes.

The Pearl™ Diabetes Management System is intended for continuous, subcutaneous delivery of insulin at programmable basal and bolus rates for the management of diabetes mellitus in adult patients requiring insulin.

The Pearl™ Diabetes Management System is a continuous, programmable insulin delivery system. It consists of a controller, a single use pump body and an infusion set adapter. The controller unit has a user interface to program delivery parameters for basal and bolus insulin delivery. It attaches to the pump body. The pump body provides the drive mechanism and battery power and holds the pre-filled insulin cartridges. The infusion set adapter is the conduit from the insulin cartridge to the final delivery tubing.