No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 00853052007240 | 1000353 | t:slim X2 Pump, Replacement, Refurb. | LZG | Pump, Infusion, Insulin | 2 | t:slim X2 Pump, Replacement, Refurb. | |
2 | 00853052007233 | 1000728 | t:slim G4 / X2 Cartridge, t:lock, 2 Pack | OYC | Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor | t:slim X2 Cartridge, t:lock, 2 Pack | ||
3 | 00852162004408 | 006194 | The #1-rated insulin pump is now integrated with the #1-rated Continuous Glucose The #1-rated insulin pump is now integrated with the #1-rated Continuous Glucose Monitoring brand that set the standard for accuracy and performance in sensor-augmented pumps. The t:slim G4 Pump is the only pump that conveniently combines CGM graphs and trend information with current insulin delivery together on a single color touch screen to help you make more informed decisions. | OYC | Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor | 3 | t:slim G4 Insulin Pump with Dexcom G4 Platinum CGM | |
4 | 00852162004385 | 005365 | Assembly, Packaged Pump, t:flex | LZG | Pump, Infusion, Insulin | 2 | t:flex Insulin Pump | |
5 | 00853052007981 | 1003808 | t:slim X2 5.x Insulin Pump, Replacement, Refurbished | OYC | Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor | 3 | t:slim X2 5.x Insulin Pump | |
6 | 00853052007776 | 1000991 | 1002541 | t:slim Cartridge, t:lock, 10 Pack | LZG,QFG | Pump, Infusion, Insulin,Alternate Controller Enabled Insulin Infusion Pump | t:slim Cartridge, t:lock, 10 Pack | |
7 | 00853052007516 | 1000991 | t:slim Cartridge, t:lock, 10 Pack | LZG | Pump, Infusion, Insulin | t:slim Cartridge, t:lock, 10 Pack | ||
8 | 00853052007479 | 1000992 | t:slim Cartridge, t:lock, 2 Pack | LZG | Pump, Infusion, Insulin | t:slim Cartridge, t:lock, 2 Pack | ||
9 | 00852162004743 | 007689 | t:flex Insulin Pump Cartridges 2 pack | LZG | Pump, Infusion, Insulin | t:flex Cartridge 2 Pack | ||
10 | 00852162004545 | 007262 | t:slim Insulin Pump, Reconditioned Replacement | LZG | Pump, Infusion, Insulin | 2 | t:slim Insulin Pump, Reconditioned Replacement | |
11 | 00852162004392 | 004695 | t:flex Insulin Pump Cartridges 10 pack | LZG | Pump, Infusion, Insulin | t:flex Cartridge 10 Pack | ||
12 | 00853052007226 | 1000727 | t:slim G4 / X2 Cartridge, t:lock, 10 Pack | OYC | Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor | t:slim X2 Cartridge, t:lock, 10 Pack | ||
13 | 00852162004422 | 007527 | The #1-rated insulin pump is now integrated with the #1-rated Continuous Glucose The #1-rated insulin pump is now integrated with the #1-rated Continuous Glucose Monitoring brand that set the standard for accuracy and performance in sensor-augmented pumps. The t:slim G4 Pump is the only pump that conveniently combines CGM graphs and trend information with current insulin delivery together on a single color touch screen to help you make more informed decisions. | OYC | Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor | t:slim G4 Cartridge 2 Pack | ||
14 | 00852162004378 | 007444 | Insulin Pump, Reconditioned 4YR Warranty, t:slim | LZG | Pump, Infusion, Insulin | 2 | t:slim Insulin Pump, Reconditioned | |
15 | 00850006613793 | 1006408 | t:slim X2 Insulin Pump with Control-IQ, 7.4.x, Refurbished Replacement | QFG,QJI,NDC | Alternate Controller Enabled Insulin Infusion Pump,Interoperable Automated Glyce Alternate Controller Enabled Insulin Infusion Pump,Interoperable Automated Glycemic Controller,Calculator, Drug Dose | 2 | t:slim X2 Insulin Pump with Control-IQ | |
16 | 00850006613786 | 1006406 | t:slim X2 Insulin Pump with Control-IQ, 7.4.x, Replacement | QFG,QJI,NDC | Alternate Controller Enabled Insulin Infusion Pump,Interoperable Automated Glyce Alternate Controller Enabled Insulin Infusion Pump,Interoperable Automated Glycemic Controller,Calculator, Drug Dose | 2 | t:slim X2 Insulin Pump with Control-IQ | |
17 | 00850006613779 | 1006404 | t:slim X2 Insulin Pump with Control-IQ, 7.4.x, Medicare | QFG,QJI,NDC | Alternate Controller Enabled Insulin Infusion Pump,Interoperable Automated Glyce Alternate Controller Enabled Insulin Infusion Pump,Interoperable Automated Glycemic Controller,Calculator, Drug Dose | 2 | t:slim X2 Insulin Pump with Control-IQ | |
18 | 00850006613762 | 1006402 | t:slim X2 Insulin Pump with Control-IQ, 7.4.x | QFG,QJI,NDC | Alternate Controller Enabled Insulin Infusion Pump,Interoperable Automated Glyce Alternate Controller Enabled Insulin Infusion Pump,Interoperable Automated Glycemic Controller,Calculator, Drug Dose | 2 | t:slim X2 Insulin Pump with Control-IQ | |
19 | 00850006613274 | 1004128 | t:connect Mobile Application (iOS) | PJT | Continuous Glucose Monitor Secondary Display | 2 | t:connect Mobile Application (iOS) | |
20 | 00850006613229 | 1005012 | t:slim X2 Insulin Pump with Control-IQ, 7.x, Reconditioned | QJI,QFG | Interoperable Automated Glycemic Controller,Alternate Controller Enabled Insulin Interoperable Automated Glycemic Controller,Alternate Controller Enabled Insulin Infusion Pump | 2 | t:slim X2 Insulin Pump with Control-IQ | |
21 | 00850006613212 | 1005013 | t:slim X2 Insulin Pump with Control-IQ, 7.x, Replacement | QFG,QJI | Alternate Controller Enabled Insulin Infusion Pump,Interoperable Automated Glyce Alternate Controller Enabled Insulin Infusion Pump,Interoperable Automated Glycemic Controller | 2 | t:slim X2 Insulin Pump with Control-IQ | |
22 | 00850006613205 | 1005011 | t:slim X2 Insulin Pump with Control-IQ, 7.x | QFG,QJI | Alternate Controller Enabled Insulin Infusion Pump,Interoperable Automated Glyce Alternate Controller Enabled Insulin Infusion Pump,Interoperable Automated Glycemic Controller | 2 | t:slim X2 Insulin Pump with Control-IQ | |
23 | 00389152000107 | 1009643 | 1010012 | t:slim X2 Insulin Pump with Control-IQ, 7.6.x, Refurbished Replacement | QFG,QJS,NDC | Alternate Controller Enabled Insulin Infusion Pump,Interoperable Automated Glyce Alternate Controller Enabled Insulin Infusion Pump,Interoperable Automated Glycemic Controller, Insulin Suspend,Calculator, Drug Dose | 2 | t:slim X2 Insulin Pump with Control-IQ |
24 | 00389152000091 | 1009641 | 1010011 | t:slim X2 Insulin Pump with Control-IQ, 7.6.x, Medicare | QFG,QJS,NDC | Alternate Controller Enabled Insulin Infusion Pump,Interoperable Automated Glyce Alternate Controller Enabled Insulin Infusion Pump,Interoperable Automated Glycemic Controller, Insulin Suspend,Calculator, Drug Dose | 2 | t:slim X2 Insulin Pump with Control-IQ |
25 | 00389152000084 | 1009642 | 1010010 | t:slim X2 Insulin Pump with Control-IQ, 7.6.x, Replacement | QFG,QJS,NDC | Alternate Controller Enabled Insulin Infusion Pump,Interoperable Automated Glyce Alternate Controller Enabled Insulin Infusion Pump,Interoperable Automated Glycemic Controller, Insulin Suspend,Calculator, Drug Dose | 2 | t:slim X2 Insulin Pump with Control-IQ |
26 | 00389152000077 | 1009637 | 1010009 | t:slim X2 Insulin Pump with Control-IQ, 7.6.x | QFG,QJS,NDC | Alternate Controller Enabled Insulin Infusion Pump,Interoperable Automated Glyce Alternate Controller Enabled Insulin Infusion Pump,Interoperable Automated Glycemic Controller, Insulin Suspend,Calculator, Drug Dose | 2 | t:slim X2 Insulin Pump with Control-IQ |
27 | 00853052007325 | 1000912 | t:slim X2 Insulin Pump with Basal-IQ, Refurbished, 6.0 | OZO | Automated Insulin Dosing , Threshold Suspend | 3 | t:slim X2 Insulin Pump with Basal-IQ | |
28 | 00853052007301 | 1000898 | t:slim X2 Insulin Pump with Basal-IQ, Reconditioned, 6.0 | OZO | Automated Insulin Dosing , Threshold Suspend | 3 | t:slim X2 Insulin Pump with Basal-IQ | |
29 | 00853052007288 | 1000892 | t:slim X2 Insulin Pump with Basal-IQ, Replacement, 6.0 | OZO | Automated Insulin Dosing , Threshold Suspend | 3 | t:slim X2 Insulin Pump with Basal-IQ | |
30 | 00853052007264 | 1000886 | t:slim X2 Insulin Pump with Basal-IQ, 6.0 | OZO | Automated Insulin Dosing , Threshold Suspend | 3 | t:slim X2 Insulin Pump with Basal-IQ | |
31 | 00850006613731 | 1006379 | t:slim X2 Insulin Pump with Basal-IQ, 6.4.x, Refurbished Replacement | QFG,QJS,NDC | Alternate Controller Enabled Insulin Infusion Pump,Interoperable Automated Glyce Alternate Controller Enabled Insulin Infusion Pump,Interoperable Automated Glycemic Controller, Insulin Suspend,Calculator, Drug Dose | 2 | t:slim X2 Insulin Pump with Basal-IQ | |
32 | 00850006613724 | 1006377 | t:slim X2 Insulin Pump with Basal-IQ, 6.4.x, Replacement | QFG,QJS,NDC | Alternate Controller Enabled Insulin Infusion Pump,Interoperable Automated Glyce Alternate Controller Enabled Insulin Infusion Pump,Interoperable Automated Glycemic Controller, Insulin Suspend,Calculator, Drug Dose | 2 | t:slim X2 Insulin Pump with Basal-IQ | |
33 | 00850006613717 | 1006375 | t:slim X2 Insulin Pump with Basal-IQ, 6.4.x, Medicare | QFG,QJS,NDC | Alternate Controller Enabled Insulin Infusion Pump,Interoperable Automated Glyce Alternate Controller Enabled Insulin Infusion Pump,Interoperable Automated Glycemic Controller, Insulin Suspend,Calculator, Drug Dose | 2 | t:slim X2 Insulin Pump with Basal-IQ | |
34 | 00850006613700 | 1006373 | t:slim X2 Insulin Pump with Basal-IQ, 6.4.x | QFG,QJS,NDC | Alternate Controller Enabled Insulin Infusion Pump,Interoperable Automated Glyce Alternate Controller Enabled Insulin Infusion Pump,Interoperable Automated Glycemic Controller, Insulin Suspend,Calculator, Drug Dose | 2 | t:slim X2 Insulin Pump with Basal-IQ | |
35 | 00850006613380 | 1005706 | t:slim X2 Insulin Pump with Basal-IQ, 6.3.x, Refurbished | OZO | Automated Insulin Dosing , Threshold Suspend | 3 | t:slim X2 Insulin Pump with Basal-IQ | |
36 | 00850006613373 | 1005698 | t:slim X2 Insulin Pump with Basal-IQ, 6.3.x | OZO | Automated Insulin Dosing , Threshold Suspend | 3 | t:slim X2 Insulin Pump with Basal-IQ | |
37 | 00389152000046 | 1009640 | 1010007 | t:slim X2 Insulin Pump with Basal-IQ, 6.6.x, Refurbished Replacement | QFG,QJS,NDC | Alternate Controller Enabled Insulin Infusion Pump,Interoperable Automated Glyce Alternate Controller Enabled Insulin Infusion Pump,Interoperable Automated Glycemic Controller, Insulin Suspend,Calculator, Drug Dose | 2 | t:slim X2 Insulin Pump with Basal-IQ |
38 | 00389152000039 | 1009638 | 1010006 | t:slim X2 Insulin Pump with Basal-IQ, 6.6.x, Medicare | QFG,QJS,NDC | Alternate Controller Enabled Insulin Infusion Pump,Interoperable Automated Glyce Alternate Controller Enabled Insulin Infusion Pump,Interoperable Automated Glycemic Controller, Insulin Suspend,Calculator, Drug Dose | 2 | t:slim X2 Insulin Pump with Basal-IQ |
39 | 00389152000015 | 1009636 | 1010004 | t:slim X2 Insulin Pump with Basal-IQ, 6.6.x | QFG,QJS,NDC | Alternate Controller Enabled Insulin Infusion Pump,Interoperable Automated Glyce Alternate Controller Enabled Insulin Infusion Pump,Interoperable Automated Glycemic Controller, Insulin Suspend,Calculator, Drug Dose | 2 | t:slim X2 Insulin Pump with Basal-IQ |
40 | 00852162004798 | 1000369 | t:slim X2 Insulin Pump, Reconditioned, 4YR Warranty | LZG | Pump, Infusion, Insulin | 2 | t:slim X2 Insulin Pump | |
41 | 00852162004781 | 1000103 | t:slim X2 Insulin Pump | LZG | Pump, Infusion, Insulin | 2 | t:slim X2 Insulin Pump | |
42 | 00852162004569 | 007473 | Assembly, Pump Replacement, Refurbished, t:flex | LZG | Pump, Infusion, Insulin | 2 | t:flex Insulin Pump, Replacement, Refurbished | |
43 | 00852162004552 | 007264 | Insulin Pump, Replacement, t:slim | LZG | Pump, Infusion, Insulin | 2 | t:slim Insulin Pump, Replacement | |
44 | 00852162004439 | 007829 | 007829 | A replacement t:slim G4 Insulin Pump with Dexcom G4 Platinum CGM. | OYC | Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor | 3 | t:slim G4 Insulin Pump with Dexcom G4 Platinum CGM, Replacement |
45 | 00853052007967 | 1003487 | t:slim X2 5.0 Insulin Pump, Replacement | OYC | Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor | 3 | t:slim X2 5.0 Insulin Pump | |
46 | 00853052007509 | 1001391 | t:flex Insulin Pump Cartridges, t:lock, 2 pack | LZG | Pump, Infusion, Insulin | t:flex Cartridge, t:lock, 2 Pack | ||
47 | 00853052007318 | 1000911 | t:slim X2 5.0 Insulin Pump, Refurbished | OYC | Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor | 3 | t:slim X2 5.0 Insulin Pump | |
48 | 00853052007295 | 1000897 | t:slim X2 5.0 Insulin Pump, Reconditioned | OYC | Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor | 3 | t:slim X2 5.0 Insulin Pump | |
49 | 00853052007271 | 1000891 | t:slim X2 5.0 Insulin Pump, Replacement | OYC | Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor | 3 | t:slim X2 5.0 Insulin Pump | |
50 | 00853052007257 | 1000885 | t:slim X2 5.0 Insulin Pump | OYC | Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor | 3 | t:slim X2 5.0 Insulin Pump |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 00763000645298 | MMT-105EVELWW | inpen™ | COMPANION MEDICAL, INC. | ||
2 | 00763000645281 | MMT-105EVNNWW | inpen™ | COMPANION MEDICAL, INC. | ||
3 | 00389152000107 | 1009643 | 1010012 | t:slim X2 Insulin Pump with Control-IQ, 7.6.x, Refurbished Replacement | t:slim X2 Insulin Pump with Control-IQ | TANDEM DIABETES CARE, INC. |
4 | 00389152000107 | 1009643 | 1010012 | t:slim X2 Insulin Pump with Control-IQ, 7.6.x, Refurbished Replacement | t:slim X2 Insulin Pump with Control-IQ | TANDEM DIABETES CARE, INC. |
5 | 00389152000107 | 1009643 | 1010012 | t:slim X2 Insulin Pump with Control-IQ, 7.6.x, Refurbished Replacement | t:slim X2 Insulin Pump with Control-IQ | TANDEM DIABETES CARE, INC. |
6 | 00389152000091 | 1009641 | 1010011 | t:slim X2 Insulin Pump with Control-IQ, 7.6.x, Medicare | t:slim X2 Insulin Pump with Control-IQ | TANDEM DIABETES CARE, INC. |
7 | 00389152000091 | 1009641 | 1010011 | t:slim X2 Insulin Pump with Control-IQ, 7.6.x, Medicare | t:slim X2 Insulin Pump with Control-IQ | TANDEM DIABETES CARE, INC. |
8 | 00389152000091 | 1009641 | 1010011 | t:slim X2 Insulin Pump with Control-IQ, 7.6.x, Medicare | t:slim X2 Insulin Pump with Control-IQ | TANDEM DIABETES CARE, INC. |
9 | 00389152000084 | 1009642 | 1010010 | t:slim X2 Insulin Pump with Control-IQ, 7.6.x, Replacement | t:slim X2 Insulin Pump with Control-IQ | TANDEM DIABETES CARE, INC. |
10 | 00389152000084 | 1009642 | 1010010 | t:slim X2 Insulin Pump with Control-IQ, 7.6.x, Replacement | t:slim X2 Insulin Pump with Control-IQ | TANDEM DIABETES CARE, INC. |
11 | 00389152000084 | 1009642 | 1010010 | t:slim X2 Insulin Pump with Control-IQ, 7.6.x, Replacement | t:slim X2 Insulin Pump with Control-IQ | TANDEM DIABETES CARE, INC. |
12 | 00389152000077 | 1009637 | 1010009 | t:slim X2 Insulin Pump with Control-IQ, 7.6.x | t:slim X2 Insulin Pump with Control-IQ | TANDEM DIABETES CARE, INC. |
13 | 00389152000077 | 1009637 | 1010009 | t:slim X2 Insulin Pump with Control-IQ, 7.6.x | t:slim X2 Insulin Pump with Control-IQ | TANDEM DIABETES CARE, INC. |
14 | 00389152000077 | 1009637 | 1010009 | t:slim X2 Insulin Pump with Control-IQ, 7.6.x | t:slim X2 Insulin Pump with Control-IQ | TANDEM DIABETES CARE, INC. |
15 | 00389152000046 | 1009640 | 1010007 | t:slim X2 Insulin Pump with Basal-IQ, 6.6.x, Refurbished Replacement | t:slim X2 Insulin Pump with Basal-IQ | TANDEM DIABETES CARE, INC. |
16 | 00389152000046 | 1009640 | 1010007 | t:slim X2 Insulin Pump with Basal-IQ, 6.6.x, Refurbished Replacement | t:slim X2 Insulin Pump with Basal-IQ | TANDEM DIABETES CARE, INC. |
17 | 00389152000046 | 1009640 | 1010007 | t:slim X2 Insulin Pump with Basal-IQ, 6.6.x, Refurbished Replacement | t:slim X2 Insulin Pump with Basal-IQ | TANDEM DIABETES CARE, INC. |
18 | 00389152000039 | 1009638 | 1010006 | t:slim X2 Insulin Pump with Basal-IQ, 6.6.x, Medicare | t:slim X2 Insulin Pump with Basal-IQ | TANDEM DIABETES CARE, INC. |
19 | 00389152000039 | 1009638 | 1010006 | t:slim X2 Insulin Pump with Basal-IQ, 6.6.x, Medicare | t:slim X2 Insulin Pump with Basal-IQ | TANDEM DIABETES CARE, INC. |
20 | 00389152000039 | 1009638 | 1010006 | t:slim X2 Insulin Pump with Basal-IQ, 6.6.x, Medicare | t:slim X2 Insulin Pump with Basal-IQ | TANDEM DIABETES CARE, INC. |
21 | 00389152000022 | 1009639 | 1010005 | t:slim X2 Insulin Pump with Basal-IQ, 6.6.x, Replacement | t:slim X2 Insulin Pump with Basal-IQ | TANDEM DIABETES CARE, INC. |
22 | 00389152000022 | 1009639 | 1010005 | t:slim X2 Insulin Pump with Basal-IQ, 6.6.x, Replacement | t:slim X2 Insulin Pump with Basal-IQ | TANDEM DIABETES CARE, INC. |
23 | 00389152000022 | 1009639 | 1010005 | t:slim X2 Insulin Pump with Basal-IQ, 6.6.x, Replacement | t:slim X2 Insulin Pump with Basal-IQ | TANDEM DIABETES CARE, INC. |
24 | 00389152000015 | 1009636 | 1010004 | t:slim X2 Insulin Pump with Basal-IQ, 6.6.x | t:slim X2 Insulin Pump with Basal-IQ | TANDEM DIABETES CARE, INC. |
25 | 00389152000015 | 1009636 | 1010004 | t:slim X2 Insulin Pump with Basal-IQ, 6.6.x | t:slim X2 Insulin Pump with Basal-IQ | TANDEM DIABETES CARE, INC. |
26 | 00389152000015 | 1009636 | 1010004 | t:slim X2 Insulin Pump with Basal-IQ, 6.6.x | t:slim X2 Insulin Pump with Basal-IQ | TANDEM DIABETES CARE, INC. |
27 | 00365702700017 | 07250452001 | ACCU-CHEK CONNECT DIABETES MANAGEMENT AP | ACCU-CHEK CONNECT | ROCHE DIAGNOSTICS OPERATIONS, INC. | |
28 | 00365702700000 | 07562462001 | ACCU-CHEK CONNECT DIABETES MGMT iAP | ACCU-CHEK CONNECT | ROCHE DIAGNOSTICS OPERATIONS, INC. | |
29 | B553BLUESTARRX710 | v7.1 | BlueStar® Rx is a Software as a Medical Device (SaMD) intended to be used by hea BlueStar® Rx is a Software as a Medical Device (SaMD) intended to be used by healthcare providers (HCPs) and their patients – aged 18 years and older - who have type 1 or type 2 diabetes. BlueStar Rx is intended to assist patients in managing their diabetes with guidance from their providers.BlueStar® Rx is indicated for use by healthcare providers (HCPs) and their patients – aged 18 years and older - who have type 1 or type 2 diabetes. BlueStar Rx is intended to provide secure capture, storage, and transmission of glucose data as well as information to aid in diabetes self-management. BlueStar Rx analyzes, and reports glucose test results and supports medication adherence. In addition, BlueStar Rx provides coaching messages (motivational, behavioral, and educational) based on real-time glucose values and trends. It includes software intended for use on mobile phones or personal computers in the home or in professional healthcare settings. The software also allows for entry of other diabetes-related healthcare information and provides educational information.BlueStar is not intended to replace the care provided by a licensed healthcare professional, including prescriptions, diagnosis, or treatment. | Bluestar | WELLDOC, INC. | |
30 | B553BLUESTAR710 | v7.1 | BlueStar is a Software as a Medical Device (SaMD) intended to be used by healthc BlueStar is a Software as a Medical Device (SaMD) intended to be used by healthcare providers (HCPs) and their patients – aged 18 years and older - who have type 1 or type 2 diabetes. BlueStar is intended to assist patients in managing their diabetes with guidance from their providersBlueStar® is indicated for use by healthcare providers (HCPs) and their patients – aged 18 years and older - who have type 1 or type 2 diabetes. BlueStar is intended to provide secure capture, storage, and transmission of glucose data as well as information to aid in diabetes self-management. BlueStar analyzes, and reports glucose test results and supports medication adherence. In addition, BlueStar provides coaching messages (motivational, behavioral, and educational) based on real-time glucose values and trends. It includes software intended for use on mobile phones or personal computers in the home or in professional healthcare settings. The software also allows for entry of other diabetes-related healthcare information and provides educational information.BlueStar is not intended to replace the care provided by a licensed healthcare professional, including prescriptions, diagnosis, or treatment. | Bluestar | WELLDOC, INC. | |
31 | 90850018992452 | 1007111 | t:connect Mobile Application, Mobile Bolus Enabled, 2.x (iOS) | t:connect Mobile Application, Mobile Bolus Enabled (iOS) | TANDEM DIABETES CARE, INC. | |
32 | 90850018992445 | 1007112 | t:connect Mobile Application, Mobile Bolus Enabled, 2.x (Android) | t:connect Mobile Application, Mobile Bolus Enabled (Android) | TANDEM DIABETES CARE, INC. | |
33 | 10862088000368 | Novo - Pink | InPen-100NN-PK / MMT-105NNPK | The InPen is a home-use reusable pen injector for single-patient use by people w The InPen is a home-use reusable pen injector for single-patient use by people with diabetes under the supervision of an adult caregiver, or by a patient age 7 and older for the self-injection of a desired dose of insulin. The pen injector is compatible with Lilly Humalog® U-100 3.0 mL cartridges, Novo Nordisk Novolog® U-100 3.0 mL cartridges, and Novo Nordisk Fiasp® U-100 3.0 mL cartridges and single-use detachable and disposable pen needles (not included). The pen injector allows the user to dial the desired dose from 0.5 to 30 units in one-half (1/2) unit increments. The InPen dose calculator, a component of the InPen app, is indicated for the management of diabetes by people with diabetes under the supervision of an adult caregiver, or by a patient age 7 and older for calculating an insulin dose or carbohydrate intake based on user entered data.For an insulin dose based on amount of carbohydrates, a healthcare professional must provide patient-specific target blood glucose, insulin-to-carbohydrate ratio, and insulin sensitivity parameters to be programmed into the software prior to use. For an insulin dose based on fixed/variable meal sizes, a healthcare professional must provide patient-specific fixed doses/meal sizes to be programmed into the software prior to use. | InPen Smart Insulin Delivery System | COMPANION MEDICAL, INC. |
34 | 10862088000351 | Novo - Grey | InPen-100NN-GY / MMT-105NNGY | The InPen is a home-use reusable pen injector for single-patient use by people w The InPen is a home-use reusable pen injector for single-patient use by people with diabetes under the supervision of an adult caregiver, or by a patient age 7 and older for the self-injection of a desired dose of insulin. The pen injector is compatible with Lilly Humalog® U-100 3.0 mL cartridges, Novo Nordisk Novolog® U-100 3.0 mL cartridges, and Novo Nordisk Fiasp® U-100 3.0 mL cartridges and single-use detachable and disposable pen needles (not included). The pen injector allows the user to dial the desired dose from 0.5 to 30 units in one-half (1/2) unit increments. The InPen dose calculator, a component of the InPen app, is indicated for the management of diabetes by people with diabetes under the supervision of an adult caregiver, or by a patient age 7 and older for calculating an insulin dose or carbohydrate intake based on user entered data.For an insulin dose based on amount of carbohydrates, a healthcare professional must provide patient-specific target blood glucose, insulin-to-carbohydrate ratio, and insulin sensitivity parameters to be programmed into the software prior to use. For an insulin dose based on fixed/variable meal sizes, a healthcare professional must provide patient-specific fixed doses/meal sizes to be programmed into the software prior to use. | InPen Smart Insulin System | COMPANION MEDICAL, INC. |
35 | 10862088000344 | Novo - Blue | InPen-100NN-BL / MMT-105NNBL | The InPen is a home-use reusable pen injector for single-patient use by people w The InPen is a home-use reusable pen injector for single-patient use by people with diabetes under the supervision of an adult caregiver, or by a patient age 7 and older for the self-injection of a desired dose of insulin. The pen injector is compatible with Lilly Humalog® U-100 3.0 mL cartridges, Novo Nordisk Novolog® U-100 3.0 mL cartridges, and Novo Nordisk Fiasp® U-100 3.0 mL cartridges and single-use detachable and disposable pen needles (not included). The pen injector allows the user to dial the desired dose from 0.5 to 30 units in one-half (1/2) unit increments. The InPen dose calculator, a component of the InPen app, is indicated for the management of diabetes by people with diabetes under the supervision of an adult caregiver, or by a patient age 7 and older for calculating an insulin dose or carbohydrate intake based on user entered data.For an insulin dose based on amount of carbohydrates, a healthcare professional must provide patient-specific target blood glucose, insulin-to-carbohydrate ratio, and insulin sensitivity parameters to be programmed into the software prior to use. For an insulin dose based on fixed/variable meal sizes, a healthcare professional must provide patient-specific fixed doses/meal sizes to be programmed into the software prior to use. | InPen Smart Insulin Delivery System | COMPANION MEDICAL, INC. |
36 | 10862088000337 | Lilly - Pink | InPen-100EL-PK / MMT-105ELPK | The InPen is a home-use reusable pen injector for single-patient use by people w The InPen is a home-use reusable pen injector for single-patient use by people with diabetes under the supervision of an adult caregiver, or by a patient age 7 and older for the self-injection of a desired dose of insulin. The pen injector is compatible with Lilly Humalog® U-100 3.0 mL cartridges, Novo Nordisk Novolog® U-100 3.0 mL cartridges, and Novo Nordisk Fiasp® U-100 3.0 mL cartridges and single-use detachable and disposable pen needles (not included). The pen injector allows the user to dial the desired dose from 0.5 to 30 units in one-half (1/2) unit increments. The InPen dose calculator, a component of the InPen app, is indicated for the management of diabetes by people with diabetes under the supervision of an adult caregiver, or by a patient age 7 and older for calculating an insulin dose or carbohydrate intake based on user entered data.For an insulin dose based on amount of carbohydrates, a healthcare professional must provide patient-specific target blood glucose, insulin-to-carbohydrate ratio, and insulin sensitivity parameters to be programmed into the software prior to use. For an insulin dose based on fixed/variable meal sizes, a healthcare professional must provide patient-specific fixed doses/meal sizes to be programmed into the software prior to use. | InPen Smart Insulin Delivery System | COMPANION MEDICAL, INC. |
37 | 10862088000320 | Lilly - Grey | InPen-100EL-GY / MMT-105ELGY | The InPen is a home-use reusable pen injector for single-patient use by people w The InPen is a home-use reusable pen injector for single-patient use by people with diabetes under the supervision of an adult caregiver, or by a patient age 7 and older for the self-injection of a desired dose of insulin. The pen injector is compatible with Lilly Humalog® U-100 3.0 mL cartridges, Novo Nordisk Novolog® U-100 3.0 mL cartridges, and Novo Nordisk Fiasp® U-100 3.0 mL cartridges and single-use detachable and disposable pen needles (not included). The pen injector allows the user to dial the desired dose from 0.5 to 30 units in one-half (1/2) unit increments. The InPen dose calculator, a component of the InPen app, is indicated for the management of diabetes by people with diabetes under the supervision of an adult caregiver, or by a patient age 7 and older for calculating an insulin dose or carbohydrate intake based on user entered data.For an insulin dose based on amount of carbohydrates, a healthcare professional must provide patient-specific target blood glucose, insulin-to-carbohydrate ratio, and insulin sensitivity parameters to be programmed into the software prior to use. For an insulin dose based on fixed/variable meal sizes, a healthcare professional must provide patient-specific fixed doses/meal sizes to be programmed into the software prior to use. | InPen Smart Insulin Delivery System | COMPANION MEDICAL, INC. |
38 | 10862088000313 | Lilly - Blue | InPen-100EL-BL / MMT-105ELBL | The InPen is a home-use reusable pen injector for single-patient use by people w The InPen is a home-use reusable pen injector for single-patient use by people with diabetes under the supervision of an adult caregiver, or by a patient age 7 and older for the self-injection of a desired dose of insulin. The pen injector is compatible with Lilly Humalog® U-100 3.0 mL cartridges, Novo Nordisk Novolog® U-100 3.0 mL cartridges, and Novo Nordisk Fiasp® U-100 3.0 mL cartridges and single-use detachable and disposable pen needles (not included). The pen injector allows the user to dial the desired dose from 0.5 to 30 units in one-half (1/2) unit increments. The InPen dose calculator, a component of the InPen app, is indicated for the management of diabetes by people with diabetes under the supervision of an adult caregiver, or by a patient age 7 and older for calculating an insulin dose or carbohydrate intake based on user entered data.For an insulin dose based on amount of carbohydrates, a healthcare professional must provide patient-specific target blood glucose, insulin-to-carbohydrate ratio, and insulin sensitivity parameters to be programmed into the software prior to use. For an insulin dose based on fixed/variable meal sizes, a healthcare professional must provide patient-specific fixed doses/meal sizes to be programmed into the software prior to use. | InPen Smart Insulin Delivery System | COMPANION MEDICAL, INC. |
39 | 10385083000114 | POD-BLE-H1-520 | Omnipod 5 Pod | Omnipod 5 Pod | INSULET CORPORATION | |
40 | 10385083000022 | PDM-H001-G-XX | SKT-H001-G-X9 | Omnipod 5 Controller (PDM) mg/dl - English with PodPals | Omnipod 5 Controller | INSULET CORPORATION |
41 | 10385083000022 | PDM-H001-G-XX | SKT-H001-G-X9 | Omnipod 5 Controller (PDM) mg/dl - English with PodPals | Omnipod 5 Controller | INSULET CORPORATION |
42 | 10385082000009 | PDM-USA1-DOO1-MG-USA1 | SKT -USA 1-DOO 1-MG-ENG | Starter Kit (PDM) mg/dL - Dash, english | Omnipod DASH Starter Kit | INSULET CORPORATION |
43 | 10385081140003 | UST400 | 14500-5A | Eros PDM(Personal Diabetes Manager) | Omnipod | INSULET CORPORATION |
44 | 10385081120302 | 1.0 | Actual downloadable APP, called Omnipod 5 Controller APP | Omnipod 5 Controller APP | INSULET CORPORATION | |
45 | 10385081120302 | 1.0 | Actual downloadable APP, called Omnipod 5 Controller APP | Omnipod 5 Controller APP | INSULET CORPORATION | |
46 | 10385081120036 | ZXP420 | 19191 | Eros Pod Insulin Pump. | Omnipod | INSULET CORPORATION |
47 | 10385081120012 | UST400 | 18900-5A | Eros PDM (Personal Diabetes Manager) | Omnipod | INSULET CORPORATION |
48 | 10385081120005 | ZXP420 | 14000 | Eros Pod Insulin pump. | Omnipod | INSULET CORPORATION |
49 | G111GCR2 | 2.X | GlucoCare Intensive Glycemic Control System | GlucoCare | PRONIA MEDICAL SYSTEMS INC. | |
50 | 04030685900018 | 2.x.x | N/A | Insulin Titration App | My Dose Coach | SANOFI-AVENTIS DEUTSCHLAND GMBH |