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LivingConnected® powered by CCS Health (“LivingConnected”) includes LivingConnected Diabetes and LivingConnected Diabetes Rx, which 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. LivingConnected Diabetes and LivingConnected Diabetes Rx are intended to assist patients in managing their diabetes with guidance from their providers. LivingConnected Diabetes Rx requires a prescription.
WELLDOC, INC.
v1.X
In Commercial Distribution
- B553202141OTC0 ()
- Home pharmaceutical management support software
Healthfirst Cares 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. Healthfirst Cares Rx is intended to provide secure capture, storage, and transmission of glucose data as well as information to aid in diabetes self-management. Healthfirst Cares Rx analyzes, and reports glucose test results and supports medication adherence. In addition, Healthfirst Cares 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. The following Healthfirst Cares Rx insulin management feature is for prescription use only: For bolus insulin users with type 1 or type 2 diabetes, Healthfirst Cares Rx includes an insulin dose calculator* to allow patients to use their prescribed regimen to calculate a dose of bolus insulin for a given amount of carbohydrates and/or glucose value. Healthfirst Cares Rx is not intended to replace the care provided by a licensed healthcare professional, including prescriptions, diagnosis, or treatment.
WELLDOC, INC.
v2.X
Not in Commercial Distribution
- B553202135RX0 ()
- Home pharmaceutical management support software
Health Optimizer® is indicated for use by healthcare providers (HCPs) and their patients – aged 18 years and older - who have type 1 or type 2 diabetes. Health Optimizer is intended to provide secure capture, storage, and transmission of blood glucose data as well as information to aid in diabetes self-management. Health Optimizer analyzes and reports blood glucose test results and supports medication adherence. In addition, Health Optimizer provides coaching messages (motivational, behavioral, and educational) based on real-time blood 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.
WELLDOC, INC.
v1.9
In Commercial Distribution
- B553202093OTC0 ()
- Home pharmaceutical management support software
Health Optimizer® is indicated for use by healthcare providers (HCPs) and their patients – aged 18 years and older - who have type 1 or type 2 diabetes. Health Optimizer is intended to provide secure capture, storage, and transmission of blood glucose data as well as information to aid in diabetes self-management. Health Optimizer analyzes and reports blood glucose test results and supports medication adherence. In addition, Health Optimizer provides coaching messages (motivational, behavioral, and educational) based on real-time blood 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.
WELLDOC, INC.
v1
In Commercial Distribution
- B553202092OTC0 ()
- Home pharmaceutical management support software
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 providers
BlueStar® 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.
WELLDOC, INC.
v7.X
In Commercial Distribution
- B553202006OTC0 ()
- Home pharmaceutical management support software
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.
WELLDOC, INC.
v7.X
In Commercial Distribution
- B553202005RX0 ()
- Home pharmaceutical management support software
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.
WELLDOC, INC.
v7.X
In Commercial Distribution
- B553202004RX0 ()
- Home pharmaceutical management support software
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 providers
BlueStar® 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.
WELLDOC, INC.
v7.X
In Commercial Distribution
- B553202003OTC0 ()
- Home pharmaceutical management support software
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.
WELLDOC, INC.
v7.X
In Commercial Distribution
- B553202002RX0 ()
- Home pharmaceutical management support software
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 providers
BlueStar® 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.
WELLDOC, INC.
v7.X
In Commercial Distribution
- B553202001OTC0 ()
- Home pharmaceutical management support software