Health Optimizer Rx

GUDID B553HLTHOPTIMIZERX140

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.

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Primary Device IDB553HLTHOPTIMIZERX140
NIH Device Record Key234e9540-f6b9-45c9-824c-651b0f454045
Commercial Distribution StatusIn Commercial Distribution
Brand NameHealth Optimizer Rx
Version Model Numberv1.4
Company DUNS021217115
Company NameWELLDOC, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-888-450-3664
Emailconnect@welldoc.com
Phone1-888-450-3664
Emailconnect@welldoc.com
Phone1-888-450-3664
Emailconnect@welldoc.com
Phone1-888-450-3664
Emailconnect@welldoc.com
Phone1-888-450-3664
Emailconnect@welldoc.com
Phone1-888-450-3664
Emailconnect@welldoc.com
Phone1-888-450-3664
Emailconnect@welldoc.com
Phone1-888-450-3664
Emailconnect@welldoc.com
Phone1-888-450-3664
Emailconnect@welldoc.com
Phone1-888-450-3664
Emailconnect@welldoc.com
Phone1-888-450-3664
Emailconnect@welldoc.com
Phone1-888-450-3664
Emailconnect@welldoc.com
Phone1-888-450-3664
Emailconnect@welldoc.com
Phone1-888-450-3664
Emailconnect@welldoc.com
Phone1-888-450-3664
Emailconnect@welldoc.com
Phone1-888-450-3664
Emailconnect@welldoc.com
Phone1-888-450-3664
Emailconnect@welldoc.com
Phone1-888-450-3664
Emailconnect@welldoc.com
Phone1-888-450-3664
Emailconnect@welldoc.com
Phone1-888-450-3664
Emailconnect@welldoc.com
Phone1-888-450-3664
Emailconnect@welldoc.com
Phone1-888-450-3664
Emailconnect@welldoc.com
Phone1-888-450-3664
Emailconnect@welldoc.com
Phone1-888-450-3664
Emailconnect@welldoc.com
Phone1-888-450-3664
Emailconnect@welldoc.com
Phone1-888-450-3664
Emailconnect@welldoc.com
Phone1-888-450-3664
Emailconnect@welldoc.com
Phone1-888-450-3664
Emailconnect@welldoc.com
Phone1-888-450-3664
Emailconnect@welldoc.com
Phone1-888-450-3664
Emailconnect@welldoc.com
Phone1-888-450-3664
Emailconnect@welldoc.com
Phone1-888-450-3664
Emailconnect@welldoc.com
Phone1-888-450-3664
Emailconnect@welldoc.com
Phone1-888-450-3664
Emailconnect@welldoc.com
Phone1-888-450-3664
Emailconnect@welldoc.com
Phone1-888-450-3664
Emailconnect@welldoc.com
Phone1-888-450-3664
Emailconnect@welldoc.com
Phone1-888-450-3664
Emailconnect@welldoc.com
Phone1-888-450-3664
Emailconnect@welldoc.com
Phone1-888-450-3664
Emailconnect@welldoc.com
Phone1-888-450-3664
Emailconnect@welldoc.com
Phone1-888-450-3664
Emailconnect@welldoc.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB553HLTHOPTIMIZERX140 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MRZAccessories, Pump, Infusion

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-11-10
Device Publish Date2022-11-02

On-Brand Devices [Health Optimizer Rx]

B553HLTHOPTIMIZERX110Health Optimizer® is indicated for use by healthcare providers (HCPs) and their patients - aged
B553HLTHOPTIMIZERX120Health Optimizer® Rx is indicated for use by healthcare providers (HCPs) and their patients - a
B553HLTHOPTIMIZERX130Health Optimizer® Rx is indicated for use by healthcare providers (HCPs) and their patients - a
B553HLTHOPTIMIZERX140Health Optimizer® Rx is indicated for use by healthcare providers (HCPs) and their patients - a
B553HLTHOPTIMIZERRX160Health Optimizer® is indicated for use by healthcare providers (HCPs) and their patients – ag
B553HLTHOPTIMIZERRX170Health Optimizer® is indicated for use by healthcare providers (HCPs) and their patients – ag
B553HLTHOPTIMIZERX150Health Optimizer® Rx is indicated for use by healthcare providers (HCPs) and their patients - a
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