Welldoc Rx

GUDID B553WELLDOCRX100

Welldoc Diabetes 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. Welldoc Diabetes Rx is intended to provide secure capture, storage, and transmission of blood glucose data as well as information to aid in diabetes self-management. Welldoc Diabetes Rx analyzes and reports blood glucose test results and supports medication adherence. In addition, Welldoc Diabetes 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. Welldoc Diabetes 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 blood glucose value. Welldoc Diabetes Rx is not intended to replace the care provided by a licensed healthcare professional, including prescriptions, diagnosis, or treatment. Welldoc also includes other functions that are designed to maintain, encourage a healthy lifestyle or help users manage their disease or condition without providing specific treatment or treatment suggestions.

WELLDOC, INC.

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Primary Device IDB553WELLDOCRX100
NIH Device Record Key4855fade-40c6-4248-a42e-c3fc5152f889
Commercial Distribution StatusIn Commercial Distribution
Brand NameWelldoc Rx
Version Model Numberv1.0
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 Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone1-888-611-4794
Emailconnect@welldoc.com
Phone1-888-611-4794
Emailconnect@welldoc.com
Phone1-888-611-4794
Emailconnect@welldoc.com
Phone1-888-611-4794
Emailconnect@welldoc.com
Phone1-888-611-4794
Emailconnect@welldoc.com
Phone1-888-611-4794
Emailconnect@welldoc.com
Phone1-888-611-4794
Emailconnect@welldoc.com
Phone1-888-611-4794
Emailconnect@welldoc.com
Phone1-888-611-4794
Emailconnect@welldoc.com
Phone1-888-611-4794
Emailconnect@welldoc.com
Phone1-888-611-4794
Emailconnect@welldoc.com
Phone1-888-611-4794
Emailconnect@welldoc.com
Phone1-888-611-4794
Emailconnect@welldoc.com
Phone1-888-611-4794
Emailconnect@welldoc.com
Phone1-888-611-4794
Emailconnect@welldoc.com
Phone1-888-611-4794
Emailconnect@welldoc.com
Phone1-888-611-4794
Emailconnect@welldoc.com
Phone1-888-611-4794
Emailconnect@welldoc.com
Phone1-888-611-4794
Emailconnect@welldoc.com
Phone1-888-611-4794
Emailconnect@welldoc.com
Phone1-888-611-4794
Emailconnect@welldoc.com
Phone1-888-611-4794
Emailconnect@welldoc.com
Phone1-888-611-4794
Emailconnect@welldoc.com
Phone1-888-611-4794
Emailconnect@welldoc.com
Phone1-888-611-4794
Emailconnect@welldoc.com
Phone1-888-611-4794
Emailconnect@welldoc.com
Phone1-888-611-4794
Emailconnect@welldoc.com
Phone1-888-611-4794
Emailconnect@welldoc.com
Phone1-888-611-4794
Emailconnect@welldoc.com
Phone1-888-611-4794
Emailconnect@welldoc.com
Phone1-888-611-4794
Emailconnect@welldoc.com
Phone1-888-611-4794
Emailconnect@welldoc.com
Phone1-888-611-4794
Emailconnect@welldoc.com
Phone1-888-611-4794
Emailconnect@welldoc.com
Phone1-888-611-4794
Emailconnect@welldoc.com
Phone1-888-611-4794
Emailconnect@welldoc.com
Phone1-888-611-4794
Emailconnect@welldoc.com
Phone1-888-611-4794
Emailconnect@welldoc.com
Phone1-888-611-4794
Emailconnect@welldoc.com
Phone1-888-611-4794
Emailconnect@welldoc.com
Phone1-888-611-4794
Emailconnect@welldoc.com
Phone1-888-611-4794
Emailconnect@welldoc.com
Phone1-888-611-4794
Emailconnect@welldoc.com
Phone1-888-611-4794
Emailconnect@welldoc.com
Phone1-888-611-4794
Emailconnect@welldoc.com
Phone1-888-611-4794
Emailconnect@welldoc.com
Phone1-888-611-4794
Emailconnect@welldoc.com
Phone1-888-611-4794
Emailconnect@welldoc.com
Phone1-888-611-4794
Emailconnect@welldoc.com
Phone1-888-611-4794
Emailconnect@welldoc.com
Phone1-888-611-4794
Emailconnect@welldoc.com
Phone1-888-611-4794
Emailconnect@welldoc.com
Phone1-888-611-4794
Emailconnect@welldoc.com
Phone1-888-611-4794
Emailconnect@welldoc.com
Phone1-888-611-4794
Emailconnect@welldoc.com
Phone1-888-611-4794
Emailconnect@welldoc.com
Phone1-888-611-4794
Emailconnect@welldoc.com
Phone1-888-611-4794
Emailconnect@welldoc.com
Phone1-888-611-4794
Emailconnect@welldoc.com
Phone1-888-611-4794
Emailconnect@welldoc.com
Phone1-888-611-4794
Emailconnect@welldoc.com
Phone1-888-611-4794
Emailconnect@welldoc.com
Phone1-888-611-4794
Emailconnect@welldoc.com
Phone1-888-611-4794
Emailconnect@welldoc.com
Phone1-888-611-4794
Emailconnect@welldoc.com
Phone1-888-611-4794
Emailconnect@welldoc.com
Phone1-888-611-4794
Emailconnect@welldoc.com
Phone1-888-611-4794
Emailconnect@welldoc.com
Phone1-888-611-4794
Emailconnect@welldoc.com
Phone1-888-611-4794
Emailconnect@welldoc.com
Phone1-888-611-4794
Emailconnect@welldoc.com
Phone1-888-611-4794
Emailconnect@welldoc.com
Phone1-888-611-4794
Emailconnect@welldoc.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB553WELLDOCRX100 [Primary]

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 Date2021-08-20
Device Publish Date2021-08-12

On-Brand Devices [Welldoc Rx]

B553WELLDOCRX100Welldoc Diabetes Rx is indicated for use by healthcare providers (HCPs) and their patients – a
B553WELLDOCRX110Welldoc Diabetes Rx is indicated for use by healthcare providers (HCPs) and their patients – a
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