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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.
Health Optimizer is not intended to replace the care provided by a licensed healthcare professional, including prescriptions, diagnosis, or treatment.
WELLDOC, INC.
v1.0
Not in Commercial Distribution
- B553HLTHOPTIMIZER100 ()
- 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.
v2.0
Not in Commercial Distribution
- B553HEALTHFIRSTRX200 ()
- 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.
v1.1
Not in Commercial Distribution
- B553HEALTHFIRSTRX1108 ()
- 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.
v1.0
Not in Commercial Distribution
- B553HEALTHFIRSTRX1007 ()
- Home pharmaceutical management support software
Healthfirst Cares 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 is intended to provide secure capture, storage, and transmission of glucose data as well as information to aid in diabetes self-management. Healthfirst Cares analyzes, and reports glucose test results and supports medication adherence. In addition, Healthfirst Cares 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.
WELLDOC, INC.
v1.1
Not in Commercial Distribution
- B553HEALTHFIRST110 ()
- Home pharmaceutical management support software
Healthfirst Cares 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 is intended to provide secure capture, storage, and transmission of glucose data as well as information to aid in diabetes self-management. Healthfirst Cares analyzes, and reports glucose test results and supports medication adherence. In addition, Healthfirst Cares 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.
WELLDOC, INC.
v1.0
Not in Commercial Distribution
- B553HEALTHFIRST100 ()
- Home pharmaceutical management support software
Conifer Connect includes Conifer Connect Diabetes and Conifer Connect 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. Conifer Connect Diabetes and Conifer Connect Diabetes Rx are intended to assist patients in managing their diabetes with guidance from their providers. Conifer Connect Diabetes Rx requires a prescription.
WELLDOC, INC.
v1.0
Not in Commercial Distribution
- B553CCDIABETESRX100 ()
- Home pharmaceutical management support software
Conifer Connect includes Conifer Connect Diabetes and Conifer Connect 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. Conifer Connect Diabetes and Conifer Connect Diabetes Rx are intended to assist patients in managing their diabetes with guidance from their providers. Conifer Connect Diabetes Rx requires a prescription.
WELLDOC, INC.
v1.1
Not in Commercial Distribution
- B553CCDIABETES110 ()
- Home pharmaceutical management support software
Conifer Connect includes Conifer Connect Diabetes and Conifer Connect 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. Conifer Connect Diabetes and Conifer Connect Diabetes Rx are intended to assist patients in managing their diabetes with guidance from their providers. Conifer Connect Diabetes Rx requires a prescription.
WELLDOC, INC.
v1.0
Not in Commercial Distribution
- B553CCDIABETES100 ()
- Home pharmaceutical management support software
ByramConnect™ 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. ByramConnect Rx is intended to provide secure capture, storage, and transmission of blood glucose data as well as information to aid in diabetes self-management. ByramConnect Rx analyzes and reports blood glucose test results and supports medication adherence. In addition, ByramConnect Rx 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. ByramConnect Rx includes an insulin dose calculator to allow patients to use their prescribed regimen to calculate a dose of insulin for a given amount of carbohydrates and/or blood glucose value.
ByramConnect Rx is not intended to replace the care provided by a licensed healthcare professional, including prescriptions, diagnosis, or treatment.
ByramConnect Rx is not indicated for people with gestational diabetes or who use an insulin pump.
IMPORTANT SAFETY INFORMATION: For medical questions, please contact your healthcare provider. If you are experiencing an
emergency, please dial 911.
WELLDOC, INC.
v1.0
In Commercial Distribution
- B553BYRAMCONNECTRX100 ()
- Home pharmaceutical management support software