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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.X
In Commercial Distribution
- B552202153OTC0 ()
- Home pharmaceutical management support software
Pulse by EHE Health (“Pulse”) 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. Pulse is intended to assist patients in managing their diabetes with guidance from their providers.
WELLDOC, INC.
v1.0
Not in Commercial Distribution
- B553PULSE100 ()
- Home pharmaceutical management support software
The Plus System is indicated for use by healthcare providers (HCPs) and their patients – aged 18 years and older - who have type 1 or type 2 diabetes. The Plus System is intended to provide secure capture, storage, and transmission of blood glucose data as well as information to aid in diabetes self-management. The Plus System analyzes and reports blood glucose test results and supports medication adherence. In addition, the Plus System 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.
The Plus System 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
- B553PLUS100 ()
- Home pharmaceutical management support software
OneTouch Reveal Plus Rx is a private-labeled version of BlueStarRx.
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 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. 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, plea
WELLDOC, INC.
v1.5
Not in Commercial Distribution
- B553OTREVEALPLUSRX150 ()
- Home pharmaceutical management support software
OneTouch Reveal Plus Rx is a private-labeled version of BlueStarRx.
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 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. 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, plea
WELLDOC, INC.
v1.4
Not in Commercial Distribution
- B553OTREVEALPLUSRX140 ()
- Home pharmaceutical management support software
OneTouch Reveal Plus Rx is a private-labeled version of BlueStarRx.
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 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 21 years and older, who have 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: 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.
v1.3
Not in Commercial Distribution
- B553OTREVEALPLUSRX130 ()
- Home pharmaceutical management support software
OneTouch Reveal Plus Rx is a private-labeled version of BlueStarRx.
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 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 21 years and older, who have 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: 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.
v1.2
In Commercial Distribution
- B553OTREVEALPLUSRX120 ()
- Home pharmaceutical management support software
OneTouch Reveal Plus is a private-labeled version of BlueStar.
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.
v1.5
Not in Commercial Distribution
- B553OTREVEALPLUS150 ()
- Home pharmaceutical management support software
OneTouch Reveal Plus is a private-labeled version of BlueStar.
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.
v1.4
Not in Commercial Distribution
- B553OTREVEALPLUS140 ()
- Home pharmaceutical management support software
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.
v1.0
Not in Commercial Distribution
- B553LCDIABETES100 ()
- Home pharmaceutical management support software