60548b36-10f9-47ac-87c0-2a11704d6dafNewPublished12025-12-122025-12-04In Commercial Distribution20385083000425PackageGS11038508300041110In Commercial Distribution5-Pack10385083000411PrimaryGS1Omnipod 5 PodPOD-OMNI-I1-6220051334402Insulet Corporation1Omnipod 5 PodfalsefalsefalsefalsefalsetruetruefalsetruetruefalsefalsefalseMR Unsafetruefalse1-800-591-3455RA@insulet.com60770Ambulatory insulin infusion pump/interstitial glucose monitoring systemAn assembly of portable devices intended to simultaneously continuously monitor interstitial glucose levels and subcutaneously infuse insulin in patients with diabetes. Sometimes referred to as a closed loop artificial pancreas, it consists of a percutaneous blood glucose monitoring system (CGM), an ambulatory insulin infusion pump, and software on a dedicated handset or transmitter capable of telemetric communication with the other components. The software contains an algorithm to allow continuous communication between the two devices, and may enable the manual input of data with respect to meals and physical activity.falseActiveQFGAlternate Controller Enabled Insulin Infusion PumpQJIInteroperable Automated Glycemic Controllertruefalse