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Health Optimizer® 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. Health Optimizer Rx 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 Rx analyzes and reports blood glucose test results and supports medication adherence. In addition, Health Optimizer 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.
The following Health Optimizer Rx insulin management feature is for prescription use only: For bolus insulin users with type 1 or type 2 diabetes, Health Optimizer 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.
Health Optimizer Rx is not intended to replace the care provided by a licensed healthcare professional, including prescriptions, diagnosis, or treatment.
WELLDOC, INC.
v1.5
Not in Commercial Distribution
- B553HLTHOPTIMIZERX150 ()
- Home pharmaceutical management support software
Health Optimizer® 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. Health Optimizer Rx 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 Rx analyzes and reports blood glucose test results and supports medication adherence. In addition, Health Optimizer 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.
The following Health Optimizer Rx insulin management feature is for prescription use only: For bolus insulin users with type 1 or type 2 diabetes, Health Optimizer 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.
Health Optimizer Rx is not intended to replace the care provided by a licensed healthcare professional, including prescriptions, diagnosis, or treatment.
WELLDOC, INC.
v1.4
Not in Commercial Distribution
- B553HLTHOPTIMIZERX140 ()
- Home pharmaceutical management support software
Health Optimizer® 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. Health Optimizer Rx 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 Rx analyzes and reports blood glucose test results and supports medication adherence. In addition, Health Optimizer 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.
The following Health Optimizer Rx insulin management feature is for prescription use only: For bolus insulin users with type 1 or type 2 diabetes, Health Optimizer 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.
Health Optimizer Rx is not intended to replace the care provided by a licensed healthcare professional, including prescriptions, diagnosis, or treatment.
WELLDOC, INC.
v1.3
Not in Commercial Distribution
- B553HLTHOPTIMIZERX130 ()
- Home pharmaceutical management support software
Health Optimizer® 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. Health Optimizer Rx 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 Rx analyzes and reports blood glucose test results and supports medication adherence. In addition, Health Optimizer 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.
The following Health Optimizer Rx insulin management feature is for prescription use only: For bolus insulin users with type 1 or type 2 diabetes, Health Optimizer 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.
Health Optimizer Rx is not intended to replace the care provided by a licensed healthcare professional, including prescriptions, diagnosis, or treatment.
WELLDOC, INC.
v1.2
Not in Commercial Distribution
- B553HLTHOPTIMIZERX120 ()
- Home pharmaceutical management support software
Health Optimizer® 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. Health Optimizer Rx 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 Rx analyzes and reports blood glucose test results and supports medication adherence. In addition, Health Optimizer 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.
The following Health Optimizer Rx insulin management feature is for prescription use only: For bolus insulin users with type 1 or type 2 diabetes, Health Optimizer 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.
Health Optimizer 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
- B553HLTHOPTIMIZERX110 ()
- Home pharmaceutical management support software
Health Harmony Maestro is a component of the Health Harmony Remote Patient Monitoring system. It is a web-based software application that is used by healthcare providers for clinical data management and communication with patients.
The Health Harmony Maestro dashboard provides a snapshot of patient data including vital signs and answers to symptom and behavior questions. Patient responses and medical device readings are risk stratified based on customer and/or individual thresholds set by the clinician. Alerts display on the dashboard triage page by the most recent date. At a glance, the clinician is able to detect patient data that is outside of threshold settings. Beyond the dashboard, detailed information may be viewed at a patient level as indicated.
Clinicians can send messages to the patient that will be displayed on the Health Harmony Mobile application. Video conferencing between the clinician and patient is also available within the Health Harmony applications.
Care Innovations, LLC
Maestro RPM
Not in Commercial Distribution
- 00850040853001 ()
- Vulnerable patient home-monitoring software, professional-only
The improved Chinook LIFE™ Station Advanced contains the fully kitted LIFE™ Pack Advanced, providing public access to critical lifesaving medical supplies during public health emergencies.
Altitude Technologies Inc.
11032
In Commercial Distribution
- 00850018201759 ()
11032
- First aid kit, non-medicated, single-use
The improved Chinook LIFE™ Station Advanced contains the fully kitted LIFE™ Pack Advanced, providing public access to critical lifesaving medical supplies during public health emergencies.
Altitude Technologies Inc.
10032
In Commercial Distribution
- 00850018201742 ()
10032
- First aid kit, non-medicated, single-use
The improved Chinook LIFE™ Station Advanced contains the fully kitted LIFE™ Pack Advanced, providing public access to critical lifesaving medical supplies during public health emergencies.
Altitude Technologies Inc.
09032
In Commercial Distribution
- 00850018201735 ()
09032
- First aid kit, non-medicated, single-use
The improved Chinook LIFE™ Station Advanced contains the fully kitted LIFE™ Pack Advanced, providing public access to critical lifesaving medical supplies during public health emergencies.
Altitude Technologies Inc.
06032
In Commercial Distribution
- 00850013417452 ()
06032
- First aid kit, non-medicated, single-use