Accu-Chek Compact Plus Control L2 (Bio)The UDI information was not placed on the
Accu-Chek Compact Plus Control L2 (Bio)The UDI information was not placed on the vial label due to the new kit guidance that was published.
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.
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.
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.
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 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
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.
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.
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.
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.
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.
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.
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.
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 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.
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.
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.