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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
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.
v7.2
Not in Commercial Distribution
- B553BLUESTARRX720 ()
- 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.
v7.1
Not in Commercial Distribution
- B553BLUESTARRX710 ()
- Home pharmaceutical management support software
DIABETES SUPPORT, ANYTIME ANYWHERE™
BlueStarRx is not a pill or a shot — it's a completely new kind of approach to support you and help you manage your type 1 or type 2
diabetes. BlueStarRx’s real-time coaching fits into your daily life helping you stay on track with your diabetes self-care. It works with
you, struggles with you, achieves with you, and celebrates with you. It can help make living with diabetes easier which makes for
a healthier, happier you.
BlueStarRx is accessible from your mobile phone, tablet, or computer, and supports your healthcare provider’s instructions while
providing you with diabetes education and motivational support.
COORDINATE YOUR CARE WITH YOUR DOCTOR
Before your next diabetes check-up, you can use BlueStarRx to send your information to your doctor. This helps your healthcare
provider understand the challenges that you face between appointments so that during your office visit you can discuss a
treatment plan that is just right for you.
INDICATION FOR USE
BlueStarRx is indicated for use by healthcare providers and their adult patients, aged 18 years and older, who have type 1 or type 2 diabetes.
BlueStarRx provides secure capture, storage, and transmission of diabetes data, as well as, motivational, behavioral, and
educational coaching messages to aid in diabetes self-management. BlueStarRx is not intended to replace the care provided by a
licensed healthcare professional, including prescriptions, diagnosis, or treatment.
CONTRAINDICATIONS: Patients on insulin pumps, patients less than 18 years of age, and women who are
pregnant.
IMPORTANT SAFETY INFORMATION: For medical questions, please contact your healthcare provider. If you are experiencing an
emergency, please dial 911.
Caution: Federal law restricts this device to sale by or on the order of a physician.
For more information visit www.bluestardiabetes.com
WELLDOC, INC.
v6.2
In Commercial Distribution
- B553BLUESTARRX620 ()
- Home pharmaceutical management support software
DIABETES SUPPORT, ANYTIME ANYWHERE™
BlueStar is not a pill or a shot — it's a completely new kind of approach to support you and help you manage your type 1 or type 2
diabetes. BlueStar’s real-time coaching fits into your daily life helping you stay on track with your diabetes self-care. It works with
you, struggles with you, achieves with you, and celebrates with you. It can help make living with diabetes easier which makes for
a healthier, happier you.
BlueStar is accessible from your mobile phone, tablet, or computer, and supports your healthcare provider’s instructions while
providing you with diabetes education and motivational support.
COORDINATE YOUR CARE WITH YOUR DOCTOR
Before your next diabetes check-up, you can use BlueStar to send your information to your doctor. This helps your healthcare
provider understand the challenges that you face between appointments so that during your office visit you can discuss a
treatment plan that is just right for you.
INDICATION FOR USE
BlueStar is indicated for use by healthcare providers and their adult patients, aged 18 years and older, who have type 1 or type 2 diabetes.
BlueStar provides secure capture, storage, and transmission of diabetes data, as well as, motivational, behavioral, and
educational coaching messages to aid in diabetes self-management. BlueStar is not intended to replace the care provided by a
licensed healthcare professional, including prescriptions, diagnosis, or treatment.
CONTRAINDICATIONS: Patients on insulin pumps, patients less than 18 years of age, and women who are
pregnant.
IMPORTANT SAFETY INFORMATION: For medical questions, please contact your healthcare provider. If you are experiencing an
emergency, please dial 911.
Caution: Federal law restricts this device to sale by or on the order of a physician.
For more information visit www.bluestardiabetes.com
WELLDOC, INC.
v5.7
Not in Commercial Distribution
- B553BLUESTAR570 ()
- Home pharmaceutical management support software
DIABETES SUPPORT, ANYTIME ANYWHERE™
BlueStar is not a pill or a shot — it's a completely new kind of approach to support you and help you manage your type 1 or type 2
diabetes. BlueStar’s real-time coaching fits into your daily life helping you stay on track with your diabetes self-care. It works with
you, struggles with you, achieves with you, and celebrates with you. It can help make living with diabetes easier which makes for
a healthier, happier you.
BlueStar is accessible from your mobile phone, tablet, or computer, and supports your healthcare provider’s instructions while
providing you with diabetes education and motivational support.
COORDINATE YOUR CARE WITH YOUR DOCTOR
Before your next diabetes check-up, you can use BlueStar to send your information to your doctor. This helps your healthcare
provider understand the challenges that you face between appointments so that during your office visit you can discuss a
treatment plan that is just right for you.
INDICATION FOR USE
BlueStar is indicated for use by healthcare providers and their adult patients, aged 18 years and older, who have type 1 or type 2 diabetes.
BlueStar provides secure capture, storage, and transmission of diabetes data, as well as, motivational, behavioral, and
educational coaching messages to aid in diabetes self-management. BlueStar is not intended to replace the care provided by a
licensed healthcare professional, including prescriptions, diagnosis, or treatment.
CONTRAINDICATIONS: Patients on insulin pumps, patients less than 18 years of age, and women who are
pregnant.
IMPORTANT SAFETY INFORMATION: For medical questions, please contact your healthcare provider. If you are experiencing an
emergency, please dial 911.
Caution: Federal law restricts this device to sale by or on the order of a physician.
For more information visit www.bluestardiabetes.com
WELLDOC, INC.
v5.6
Not in Commercial Distribution
- B553BLUESTAR560 ()
- Home pharmaceutical management support software
DIABETES SUPPORT, ANYTIME ANYWHERE™
BlueStar is not a pill or a shot — it's a completely new kind of approach to support you and help you manage your type 2
diabetes. BlueStar’s real-time coaching fits into your daily life helping you stay on track with your diabetes self-care. It works with
you, struggles with you, achieves with you, and celebrates with you. It can help make living with diabetes easier which makes for
a healthier, happier you.
BlueStar is accessible from your mobile phone, tablet, or computer, and supports your healthcare provider’s instructions while
providing you with diabetes education and motivational support.
COORDINATE YOUR CARE WITH YOUR DOCTOR
Before your next diabetes check-up, you can use BlueStar to send your information to your doctor. This helps your healthcare
provider understand the challenges that you face between appointments so that during your office visit you can discuss a
treatment plan that is just right for you.
INDICATION FOR USE
BlueStar is indicated for use by healthcare providers and their adult patients, aged 21 years and older, who have type 2 diabetes.
BlueStar provides secure capture, storage, and transmission of diabetes data, as well as, motivational, behavioral, and
educational coaching messages to aid in diabetes self-management. BlueStar is not intended to replace the care provided by a
licensed healthcare professional, including prescriptions, diagnosis, or treatment.
CONTRAINDICATIONS: Type 1 diabetes, patients on insulin pumps, patients less than 21 years of age, and women who are
pregnant.
IMPORTANT SAFETY INFORMATION: For medical questions, please contact your healthcare provider. If you are experiencing an
emergency, please dial 911.
Caution: Federal law restricts this device to sale by or on the order of a physician.
For more information visit www.bluestardiabetes.com
WELLDOC, INC.
v5.4
Not in Commercial Distribution
- B553BLUESTAR540 ()
- Home pharmaceutical management support software
DIABETES SUPPORT, ANYTIME ANYWHERE™
BlueStar is not a pill or a shot — it's a completely new kind of approach to support you and help you manage your type 2
diabetes. BlueStar’s real-time coaching fits into your daily life helping you stay on track with your diabetes self-care. It works with
you, struggles with you, achieves with you, and celebrates with you. It can help make living with diabetes easier which makes for
a healthier, happier you.
BlueStar is accessible from your mobile phone, tablet, or computer, and supports your healthcare provider’s instructions while
providing you with diabetes education and motivational support.
COORDINATE YOUR CARE WITH YOUR DOCTOR
Before your next diabetes check-up, you can use BlueStar to send your information to your doctor. This helps your healthcare
provider understand the challenges that you face between appointments so that during your office visit you can discuss a
treatment plan that is just right for you.
INDICATION FOR USE
BlueStar is indicated for use by healthcare providers and their adult patients, aged 21 years and older, who have type 2 diabetes.
BlueStar provides secure capture, storage, and transmission of diabetes data, as well as, motivational, behavioral, and
educational coaching messages to aid in diabetes self-management. BlueStar is not intended to replace the care provided by a
licensed healthcare professional, including prescriptions, diagnosis, or treatment.
CONTRAINDICATIONS: Type 1 diabetes, patients on insulin pumps, patients less than 21 years of age, and women who are
pregnant.
IMPORTANT SAFETY INFORMATION: For medical questions, please contact your healthcare provider. If you are experiencing an
emergency, please dial 911.
Caution: Federal law restricts this device to sale by or on the order of a physician.
For more information visit www.bluestardiabetes.com
WELLDOC, INC.
v4.3
- 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.
2.X
In Commercial Distribution
- B553202192OTC0 ()
- 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.
2.X
In Commercial Distribution
- B553202191OTC0 ()
- Home pharmaceutical management support software