Other products from "VOLUNTIS"
No Primary DI Version or Model Catalog Number Device Description Product Code Product Code Name Device Class Brand Name
1 03760261310078 Redwing I_1.6_US NDC Calculator, Drug Dose 2 Insulia
2 03760261310061 Redwing W_1.6_US NDC Calculator, Drug Dose 2 Insulia
3 03760261310023 Redwing 1AUS NDC Calculator, Drug Dose 2 Insulia
4 03760261310016 REdwing 1IUS NDC Calculator, Drug Dose 2 Insulia
5 03760261310009 Redwing 1WUS NDC Calculator, Drug Dose 2 Insulia
Other products with the same Product Code "NDC"
No Primary DI Version or Model Catalog Number Device Description Brand Name Organization Name
1 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.
2 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.
3 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.
4 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.
5 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.
6 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.
7 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.
8 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.
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 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
11 10385081140003 UST400 14500-5A Eros PDM(Personal Diabetes Manager) Omnipod INSULET CORPORATION
12 10385081120302 1.0 Actual downloadable APP, called Omnipod 5 Controller APP Omnipod 5 Controller APP INSULET CORPORATION
13 10385081120036 ZXP420 19191 Eros Pod Insulin Pump. Omnipod INSULET CORPORATION
14 10385081120012 UST400 18900-5A Eros PDM (Personal Diabetes Manager) Omnipod INSULET CORPORATION
15 10385081120005 ZXP420 14000 Eros Pod Insulin pump. Omnipod INSULET CORPORATION
16 G111GCR2 2.X GlucoCare Intensive Glycemic Control System GlucoCare PRONIA MEDICAL SYSTEMS INC.
17 04030685900018 2.x.x N/A Insulin Titration App My Dose Coach SANOFI-AVENTIS DEUTSCHLAND GMBH
18 04030685900001 1.x.x My Dose Coach SANOFI-AVENTIS DEUTSCHLAND GMBH
19 03760261310085 Redwing A_1.6_US Insulia VOLUNTIS
20 03760261310078 Redwing I_1.6_US Insulia VOLUNTIS
21 03760261310061 Redwing W_1.6_US Insulia VOLUNTIS
22 03760261310023 Redwing 1AUS Insulia VOLUNTIS
23 03760261310016 REdwing 1IUS Insulia VOLUNTIS
24 03760261310009 Redwing 1WUS Insulia VOLUNTIS
25 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
26 00860057000305 None Glucommander GLYTEC, LLC
27 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
28 00860001044218 V1m00b053d Hygieia d-Nav System Phone App - Android Operating System d-Nav® HYGIEIA, INC.
29 00860001044201 V1m00b054i Hygieia d-Nav System Phone App - Apple iOS Operating System d-Nav® HYGIEIA, INC.
30 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.
31 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.
32 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.
33 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.
34 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.
35 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.
36 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.
37 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.
38 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.
39 00850006613762 1006402 t:slim X2 Insulin Pump with Control-IQ, 7.4.x t:slim X2 Insulin Pump with Control-IQ TANDEM DIABETES CARE, INC.
40 00850006613731 1006379 t:slim X2 Insulin Pump with Basal-IQ, 6.4.x, Refurbished Replacement t:slim X2 Insulin Pump with Basal-IQ TANDEM DIABETES CARE, INC.
41 00850006613724 1006377 t:slim X2 Insulin Pump with Basal-IQ, 6.4.x, Replacement t:slim X2 Insulin Pump with Basal-IQ TANDEM DIABETES CARE, INC.
42 00850006613717 1006375 t:slim X2 Insulin Pump with Basal-IQ, 6.4.x, Medicare t:slim X2 Insulin Pump with Basal-IQ TANDEM DIABETES CARE, INC.
43 00850006613700 1006373 t:slim X2 Insulin Pump with Basal-IQ, 6.4.x t:slim X2 Insulin Pump with Basal-IQ TANDEM DIABETES CARE, INC.
44 00850006610006 Version 2.X iSage Rx™ (iSage Rx Basal Insulin Titration) iSage Rx AMALGAM RX INC
45 00850005949183 BIOST06040F B2-ST06-04-0-00-GY (US) The BioButton™ is a remote monitoring wearable device intended to collect physio The BioButton™ is a remote monitoring wearable device intended to collect physiological data which can include heart rate, respiratory rate, skin temperature, and other symptomatic or biometric data.The device is intended for use on users who are 18 years of age or older.The device does not output heart rate or respiratory rate measurements during periods of motion or activity.The device is not intended for use on critical care patients. BioButton v3 (BBN-r) BIOINTELLISENSE, INC.
46 00850005949145 BIOST05020F SKU# B2-ST05-02-0-00-GY The BioButton™ is a remote monitoring wearable device intended to collect physio The BioButton™ is a remote monitoring wearable device intended to collect physiological data which can include heart rate, respiratory rate, skin temperature, and other symptomatic or biometric data.The device is intended for use on users who are 18 years of age or older.The device does not output heart rate or respiratory rate measurements during periods of motion or activity.The device is not intended for use on critical care patients. BioButton v2 BIOINTELLISENSE, INC.
47 00850005949107 BIOST03020F SKU# B2-ST03-02-0-00-GY The BioButton™ is a remote monitoring wearable device intended to collect physio The BioButton™ is a remote monitoring wearable device intended to collect physiological data which can include heart rate, respiratory rate, skin temperature, and other symptomatic or biometric data.The device is intended for use on users who are 18 years of age or older.The device does not output heart rate or respiratory rate measurements during periods of motion or activity.The device is not intended for use on critical care patients. BioButton BIOINTELLISENSE, INC.
48 00850005949046 SWDT10001-1.1.1 Offload Software for the BioSticker System. BioSticker™ System Offload Software BIOINTELLISENSE, INC.
49 00850005949008 BIOST01021F The BioSticker™ System is a wearable remote monitoring system intended for conti The BioSticker™ System is a wearable remote monitoring system intended for continuous collection of physiological data in home and healthcare settings. BioSticker™ BIOINTELLISENSE, INC.
50 00763000645298 MMT-105EVELWW inpen™ COMPANION MEDICAL, INC.