Other products from "INSULET CORPORATION"
No Primary DI Version or Model Catalog Number Device Description Product Code Product Code Name Device Class Brand Name
1 10385081120302 1.0 Actual downloadable APP, called Omnipod 5 Controller APP QFG,QRX,NDC Alternate Controller Enabled Insulin Infusion Pump,Continuous Glucose Monitor In Alternate Controller Enabled Insulin Infusion Pump,Continuous Glucose Monitor Informed Insulin Dose Calculator,Calculator, Drug Dose 2 Omnipod 5 Controller APP
2 10385083000114 POD-BLE-H1-520 Omnipod 5 Pod QFG,QJI Alternate Controller Enabled Insulin Infusion Pump,Interoperable Automated Glyce Alternate Controller Enabled Insulin Infusion Pump,Interoperable Automated Glycemic Controller Omnipod 5 Pod
3 10385082000023 POD-BLE-11-520 DASH Pod LZG Pump, Infusion, Insulin Omnipod DASH Pod
4 10385081140003 UST400 14500-5A Eros PDM(Personal Diabetes Manager) NBW,LZG,NDC System, Test, Blood Glucose, Over The Counter,Pump, Infusion, Insulin,Calculator System, Test, Blood Glucose, Over The Counter,Pump, Infusion, Insulin,Calculator, Drug Dose Omnipod
5 10385081120036 ZXP420 19191 Eros Pod Insulin Pump. LZG,NBW,NDC Pump, Infusion, Insulin,System, Test, Blood Glucose, Over The Counter,Calculator Pump, Infusion, Insulin,System, Test, Blood Glucose, Over The Counter,Calculator, Drug Dose Omnipod
6 10385081120012 UST400 18900-5A Eros PDM (Personal Diabetes Manager) NBW,LZG,NDC System, Test, Blood Glucose, Over The Counter,Pump, Infusion, Insulin,Calculator System, Test, Blood Glucose, Over The Counter,Pump, Infusion, Insulin,Calculator, Drug Dose 2 Omnipod
7 10385081120005 ZXP420 14000 Eros Pod Insulin pump. LZG,NBW,NDC Pump, Infusion, Insulin,System, Test, Blood Glucose, Over The Counter,Calculator Pump, Infusion, Insulin,System, Test, Blood Glucose, Over The Counter,Calculator, Drug Dose Omnipod
8 10385082000009 PDM-USA1-DOO1-MG-USA1 SKT -USA 1-DOO 1-MG-ENG Starter Kit (PDM) mg/dL - Dash, english NDC,LZG Calculator, Drug Dose,Pump, Infusion, Insulin Omnipod DASH Starter Kit
9 10385081120272 1.3.1 18239 Mobile App utilized in the PDM (Personal Device Manager) for Dash. Insulin pump Mobile App utilized in the PDM (Personal Device Manager) for Dash. Insulin pump secondary display. PDM Device 18239; app 41253 PKU Insulin Pump Secondary Display 2 Omnipod (Dash) View APP
10 10385081120234 POD-X9-990 Omnipod Adhesive Overlay (Podpals) KGX Tape And Bandage, Adhesive Omnipod PodPals
11 10385081120265 1.3.1 18239 Mobile App utilized in the PDM (Personal Device Manager) for Dash Insulin pump s Mobile App utilized in the PDM (Personal Device Manager) for Dash Insulin pump secondary display. PDM Device 18239; app 41252 PKU Insulin Pump Secondary Display 2 Omnipod (Dash) Display App.
Other products with the same Product Codes "QFG, QJI, QRX, NDC"
No Primary DI Version or Model Catalog Number Device Description Brand Name Organization Name
1 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.
2 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.
3 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.
4 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.
5 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.
6 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.
7 10385083000114 POD-BLE-H1-520 Omnipod 5 Pod Omnipod 5 Pod INSULET CORPORATION
8 10385083000114 POD-BLE-H1-520 Omnipod 5 Pod Omnipod 5 Pod INSULET CORPORATION
9 10385083000022 PDM-H001-G-XX SKT-H001-G-X9 Omnipod 5 Controller (PDM) mg/dl - English with PodPals Omnipod 5 Controller INSULET CORPORATION
10 10385083000022 PDM-H001-G-XX SKT-H001-G-X9 Omnipod 5 Controller (PDM) mg/dl - English with PodPals Omnipod 5 Controller INSULET CORPORATION
11 10385083000022 PDM-H001-G-XX SKT-H001-G-X9 Omnipod 5 Controller (PDM) mg/dl - English with PodPals Omnipod 5 Controller INSULET CORPORATION
12 10385083000022 PDM-H001-G-XX SKT-H001-G-X9 Omnipod 5 Controller (PDM) mg/dl - English with PodPals Omnipod 5 Controller INSULET CORPORATION
13 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
14 10385081140003 UST400 14500-5A Eros PDM(Personal Diabetes Manager) Omnipod INSULET CORPORATION
15 10385081120302 1.0 Actual downloadable APP, called Omnipod 5 Controller APP Omnipod 5 Controller APP INSULET CORPORATION
16 10385081120302 1.0 Actual downloadable APP, called Omnipod 5 Controller APP Omnipod 5 Controller APP INSULET CORPORATION
17 10385081120302 1.0 Actual downloadable APP, called Omnipod 5 Controller APP Omnipod 5 Controller APP INSULET CORPORATION
18 10385081120036 ZXP420 19191 Eros Pod Insulin Pump. Omnipod INSULET CORPORATION
19 10385081120012 UST400 18900-5A Eros PDM (Personal Diabetes Manager) Omnipod INSULET CORPORATION
20 10385081120005 ZXP420 14000 Eros Pod Insulin pump. Omnipod INSULET CORPORATION
21 G111GCR2 2.X GlucoCare Intensive Glycemic Control System GlucoCare PRONIA MEDICAL SYSTEMS INC.
22 04030685900018 2.x.x N/A Insulin Titration App My Dose Coach SANOFI-AVENTIS DEUTSCHLAND GMBH
23 04030685900001 1.x.x My Dose Coach SANOFI-AVENTIS DEUTSCHLAND GMBH
24 03760261310085 Redwing A_1.6_US Insulia VOLUNTIS
25 03760261310078 Redwing I_1.6_US Insulia VOLUNTIS
26 03760261310061 Redwing W_1.6_US Insulia VOLUNTIS
27 03760261310023 Redwing 1AUS Insulia VOLUNTIS
28 03760261310016 REdwing 1IUS Insulia VOLUNTIS
29 03760261310009 Redwing 1WUS Insulia VOLUNTIS
30 00861133000301 Insulin Dosing Calculator MDN GlucoStabilizer® Insulin Dosing Calculator is designed for use by order of a MDN GlucoStabilizer® Insulin Dosing Calculator is designed for use by order of a physician for hospitalized patients. It is intended to evaluate the current as well as cumulative patient blood glucose values, and based on those measurements, calculate and recommend a dose of insulin or dextrose to drive the blood glucose level either up or down towards a predetermined target range. Once that target blood glucose range has been reached, the system’s function is to recommend dosing of insulin or dextrose for the purpose of maintaining the patient’s blood glucose level in that target range. The system is programmed to provide dosing calculations of insulin and dextrose for both adult and pediatric (ages 2-18) patients. MDN GlucoStabilizer® Insulin Dosing Calculator MEDICAL DECISION NETWORK, LLC
31 00860057000305 None Glucommander GLYTEC, LLC
32 00860003340608 None EndoTool is a glucose management software system, designed for use by healthcare EndoTool is a glucose management software system, designed for use by healthcare professionals in all patient care settings to recommend intravenous and subcutaneous transition dosing, as well as carbohydrates. Evaluating current and cumulative glucose levels, the software adjusts and maintains the glucose level within a configurable clinician-determined target range. The system is indicated for use in adult and pediatric patients ages 2 years and above, who weigh 12 kgs. or more. EndoTool logic is not a substitute for, but rather an adjunct to clinical reasoning. No medical decision should be based solely on the recommended guidance provided by this software system. EndoTool MONARCH MEDICAL TECHNOLOGIES LLC
33 00860001044218 V1m00b053d Hygieia d-Nav System Phone App - Android Operating System d-Nav® HYGIEIA, INC.
34 00860001044201 V1m00b054i Hygieia d-Nav System Phone App - Apple iOS Operating System d-Nav® HYGIEIA, INC.
35 00860001009804 Version 1 Insulin Insights™ is a glycemic management software support program designed to Insulin Insights™ is a glycemic management software support program designed to provide insulin dosing recommendations to the clinician in order to adjust and maintain blood glucose levels in insulin-dependent diabetic patients within a clinician determined target range. Insulin Insights™ evaluates a set of current and cumulative patient blood glucose values together with biometric information (including age, weight, height, and gender) and suggests changes (if necessary). Insulin Insights™ is designed for use by healthcare professionals. Insulin Insights™ is indicated for use in adults and pediatric patients ages 7 and above who weigh more than 36 lbs. Insulin Insights™ MELLITUS HEALTH, INC.
36 00855093008019 18.x Glooko Mobile Insulin Dosing System is an insulin dose calculator. The Glooko MI Glooko Mobile Insulin Dosing System is an insulin dose calculator. The Glooko MIDS Web software is available for use by the prescribers on standard web browsers. Glooko Mobile Insulin Dosing (MIDS) on Glooko WebDashboard GLOOKO, INC.
37 00855093008002 5.x Glooko Mobile Insulin Dosing System (MIDS) is an insulin dose calculator. The Gl Glooko Mobile Insulin Dosing System (MIDS) is an insulin dose calculator. The Glooko MIDS Mobile Application is only available to patients who have been prescribed MIDS by their heath care provider. The mobile application can be downloaded by patients from the Google Play Store for Android and from the Apple App Store for iOS operating systems. Glooko Mobile Insulin Dosing System (MIDS) Android & iOS Mobile Application GLOOKO, INC.
38 00853052007776 1000991 1002541 t:slim Cartridge, t:lock, 10 Pack t:slim Cartridge, t:lock, 10 Pack TANDEM DIABETES CARE, INC.
39 00851831007085 10 Picis Weight Based Dose Converter: The Picis Weight Based Dose Converter is desi Picis Weight Based Dose Converter: The Picis Weight Based Dose Converter is designed for use by trained clinicians to calculate any individual patient’s dose for a given agent based on a weight based determination by the clinician. Picis Weight Based Dose Converter PICIS CLINICAL SOLUTIONS, INC.
40 00851831007061 10C The Picis Weight Based Dose Converter is designed for use by trained clinicians The Picis Weight Based Dose Converter is designed for use by trained clinicians to calculate any individual patient’s dose for a given agent based on a weight based determination by the clinician. Picis Weight Based Dose Converter PICIS CLINICAL SOLUTIONS, INC.
41 00851831007016 8.6 The Picis Weight Based Dose Converter is designed for use by trained clinicians The Picis Weight Based Dose Converter is designed for use by trained clinicians to calculate any individualpatient’s dose for a given agent based on a weight based determination by the clinician. Drug dosing for a patient must be made only after careful consideration of the full clinical status of the patient by the ordering clinician and the software provides no validation as to the appropriateness of the entered weight based dose. Picis Weight Based Dose Converter PICIS CLINICAL SOLUTIONS, INC.
42 00850006613793 1006408 t:slim X2 Insulin Pump with Control-IQ, 7.4.x, Refurbished Replacement t:slim X2 Insulin Pump with Control-IQ TANDEM DIABETES CARE, INC.
43 00850006613793 1006408 t:slim X2 Insulin Pump with Control-IQ, 7.4.x, Refurbished Replacement t:slim X2 Insulin Pump with Control-IQ TANDEM DIABETES CARE, INC.
44 00850006613793 1006408 t:slim X2 Insulin Pump with Control-IQ, 7.4.x, Refurbished Replacement t:slim X2 Insulin Pump with Control-IQ TANDEM DIABETES CARE, INC.
45 00850006613786 1006406 t:slim X2 Insulin Pump with Control-IQ, 7.4.x, Replacement t:slim X2 Insulin Pump with Control-IQ TANDEM DIABETES CARE, INC.
46 00850006613786 1006406 t:slim X2 Insulin Pump with Control-IQ, 7.4.x, Replacement t:slim X2 Insulin Pump with Control-IQ TANDEM DIABETES CARE, INC.
47 00850006613786 1006406 t:slim X2 Insulin Pump with Control-IQ, 7.4.x, Replacement t:slim X2 Insulin Pump with Control-IQ TANDEM DIABETES CARE, INC.
48 00850006613779 1006404 t:slim X2 Insulin Pump with Control-IQ, 7.4.x, Medicare t:slim X2 Insulin Pump with Control-IQ TANDEM DIABETES CARE, INC.
49 00850006613779 1006404 t:slim X2 Insulin Pump with Control-IQ, 7.4.x, Medicare t:slim X2 Insulin Pump with Control-IQ TANDEM DIABETES CARE, INC.
50 00850006613779 1006404 t:slim X2 Insulin Pump with Control-IQ, 7.4.x, Medicare t:slim X2 Insulin Pump with Control-IQ TANDEM DIABETES CARE, INC.