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| Product | Model | Company | Device type |
|---|---|---|---|
| MiniMed™ 780GMedtronic Minimed, Inc.Ambulatory insulin infusion pump, electronic, software-dosing, scalar algorithm | MMT-1884 | Medtronic Minimed, Inc. | Ambulatory insulin infusion pump, electronic, software-dosing, scalar algorithm |
| MODD1 Patient Welcome KitModular Medical, Inc.Ambulatory insulin infusion pump, electronic, non-software-dosing | MODD1 Insulin Delivery System | Modular Medical, Inc. | Ambulatory insulin infusion pump, electronic, non-software-dosing |
| myPKFiT for Patients Mobile ApplicationTakeda Pharmaceuticals U.S.A., Inc.Home pharmaceutical management support software | V2 | Takeda Pharmaceuticals U.S.A., Inc. | Home pharmaceutical management support software |
| PARADIGM® REAL-timeMedtronic Minimed, Inc.Ambulatory insulin infusion pump, electronic, non-software-dosing | MMT-522LNAB | Medtronic Minimed, Inc. | Ambulatory insulin infusion pump, electronic, non-software-dosing |
| Prometra ProgrammerFlowonix Medical, Inc.Infusion pump programmer | 12828 | Flowonix Medical, Inc. | Infusion pump programmer |
| RemunityUnited Therapeutics CorporationAmbulatory non-insulin infusion pump, electronic | DKPI-11042-001 | United Therapeutics Corporation | Ambulatory non-insulin infusion pump, electronic |
| RemunityUnited Therapeutics CorporationAmbulatory non-insulin infusion pump, electronic | DKPI-11036-001 | United Therapeutics Corporation | Ambulatory non-insulin infusion pump, electronic |
| RemunityUnited Therapeutics CorporationAmbulatory non-insulin infusion pump, electronic | DKPI-21128-001 | United Therapeutics Corporation | Ambulatory non-insulin infusion pump, electronic |
| SkyriziAbbvie Inc.Subcutaneous self-injection aid | 19558594 | Abbvie Inc. | Subcutaneous self-injection aid |
| Sugarmate, iOS Mobile ApplicationSugarmate, LLCSelf-care monitoring/reporting software | 1007228 | Sugarmate, LLC | Self-care monitoring/reporting software |
| Sugarmate, Web ApplicationSugarmate, LLCSelf-care monitoring/reporting software | 1008181 | Sugarmate, LLC | Self-care monitoring/reporting software |
| t:flex Cartridge 10 PackTandem Diabetes Care, Inc.Ambulatory insulin infusion pump reservoir | 004695 | Tandem Diabetes Care, Inc. | Ambulatory insulin infusion pump reservoir |
| t:slim X2 5.0 Insulin PumpTandem Diabetes Care, Inc.Ambulatory insulin infusion pump/blood glucose analyser system | 1000891 | Tandem Diabetes Care, Inc. | Ambulatory insulin infusion pump/blood glucose analyser system |
| t:slim X2 Insulin Pump with Control-IQ+ TechnologyTandem Diabetes Care, Inc.Ambulatory insulin infusion pump, electronic, software-dosing, scalar algorithm | 1014072 | Tandem Diabetes Care, Inc. | Ambulatory insulin infusion pump, electronic, software-dosing, scalar algorithm |
| Tempo Smart ButtonEli Lilly and CompanyPatient monitoring system module, data memory | MS6303 | Eli Lilly and Company | Patient monitoring system module, data memory |
| TempoSmartWelldoc, Inc.Home pharmaceutical management support software | 2.X | Welldoc, Inc. | Home pharmaceutical management support software |
| TigerConnect Alarm ManagementCritical AlertAlarm application software | — | Critical Alert | Alarm application software |
| twiistSequel Med Tech, LLCAmbulatory insulin infusion pump/interstitial glucose monitoring system | DKPI-11073-001 | Sequel Med Tech, LLC | Ambulatory insulin infusion pump/interstitial glucose monitoring system |
| twiistSequel Med Tech, LLCAmbulatory insulin infusion pump/interstitial glucose monitoring system | DKPI-11098-001 | Sequel Med Tech, LLC | Ambulatory insulin infusion pump/interstitial glucose monitoring system |
| VersaPump InfuserEmed Technologies CorporationAmbulatory non-insulin infusion pump, mechanical, reusable | FP-0010209 | Emed Technologies Corporation | Ambulatory non-insulin infusion pump, mechanical, reusable |