OneTouch Reveal Plus Rx

GUDID B553OTREVEALPLUSRX140

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.

Pharmaceutical management support software, patient-/professional-use
Primary Device IDB553OTREVEALPLUSRX140
NIH Device Record Key891e1f2a-fcf6-4dd9-90c0-5932b3e52063
Commercial Distribution StatusIn Commercial Distribution
Brand NameOneTouch Reveal Plus 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

Phone888-611-4794
Emailconnect@welldoc.com
Phone888-611-4794
Emailconnect@welldoc.com
Phone888-611-4794
Emailconnect@welldoc.com
Phone888-611-4794
Emailconnect@welldoc.com
Phone888-611-4794
Emailconnect@welldoc.com
Phone888-611-4794
Emailconnect@welldoc.com
Phone888-611-4794
Emailconnect@welldoc.com
Phone888-611-4794
Emailconnect@welldoc.com
Phone888-611-4794
Emailconnect@welldoc.com
Phone888-611-4794
Emailconnect@welldoc.com
Phone888-611-4794
Emailconnect@welldoc.com
Phone888-611-4794
Emailconnect@welldoc.com
Phone888-611-4794
Emailconnect@welldoc.com
Phone888-611-4794
Emailconnect@welldoc.com
Phone888-611-4794
Emailconnect@welldoc.com
Phone888-611-4794
Emailconnect@welldoc.com
Phone888-611-4794
Emailconnect@welldoc.com
Phone888-611-4794
Emailconnect@welldoc.com
Phone888-611-4794
Emailconnect@welldoc.com
Phone888-611-4794
Emailconnect@welldoc.com
Phone888-611-4794
Emailconnect@welldoc.com
Phone888-611-4794
Emailconnect@welldoc.com
Phone888-611-4794
Emailconnect@welldoc.com
Phone888-611-4794
Emailconnect@welldoc.com
Phone888-611-4794
Emailconnect@welldoc.com
Phone888-611-4794
Emailconnect@welldoc.com
Phone888-611-4794
Emailconnect@welldoc.com
Phone888-611-4794
Emailconnect@welldoc.com
Phone888-611-4794
Emailconnect@welldoc.com
Phone888-611-4794
Emailconnect@welldoc.com
Phone888-611-4794
Emailconnect@welldoc.com
Phone888-611-4794
Emailconnect@welldoc.com
Phone888-611-4794
Emailconnect@welldoc.com
Phone888-611-4794
Emailconnect@welldoc.com
Phone888-611-4794
Emailconnect@welldoc.com
Phone888-611-4794
Emailconnect@welldoc.com
Phone888-611-4794
Emailconnect@welldoc.com
Phone888-611-4794
Emailconnect@welldoc.com
Phone888-611-4794
Emailconnect@welldoc.com
Phone888-611-4794
Emailconnect@welldoc.com
Phone888-611-4794
Emailconnect@welldoc.com
Phone888-611-4794
Emailconnect@welldoc.com
Phone888-611-4794
Emailconnect@welldoc.com
Phone888-611-4794
Emailconnect@welldoc.com
Phone888-611-4794
Emailconnect@welldoc.com
Phone888-611-4794
Emailconnect@welldoc.com
Phone888-611-4794
Emailconnect@welldoc.com
Phone888-611-4794
Emailconnect@welldoc.com
Phone888-611-4794
Emailconnect@welldoc.com
Phone888-611-4794
Emailconnect@welldoc.com
Phone888-611-4794
Emailconnect@welldoc.com
Phone888-611-4794
Emailconnect@welldoc.com
Phone888-611-4794
Emailconnect@welldoc.com
Phone888-611-4794
Emailconnect@welldoc.com
Phone888-611-4794
Emailconnect@welldoc.com
Phone888-611-4794
Emailconnect@welldoc.com
Phone888-611-4794
Emailconnect@welldoc.com
Phone888-611-4794
Emailconnect@welldoc.com
Phone888-611-4794
Emailconnect@welldoc.com
Phone888-611-4794
Emailconnect@welldoc.com
Phone888-611-4794
Emailconnect@welldoc.com
Phone888-611-4794
Emailconnect@welldoc.com
Phone888-611-4794
Emailconnect@welldoc.com
Phone888-611-4794
Emailconnect@welldoc.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB553OTREVEALPLUSRX140 [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 Date2020-04-09
Device Publish Date2020-04-01

On-Brand Devices [OneTouch Reveal Plus Rx]

B553OTREVEALPLUSRX130OneTouch Reveal Plus Rx is a private-labeled version of BlueStarRx. DIABETES SUPPORT, ANYTIME
B553OTREVEALPLUSRX120OneTouch Reveal Plus Rx is a private-labeled version of BlueStarRx. DIABETES SUPPORT, ANYTIME
B553OTREVEALPLUSRX140OneTouch Reveal Plus Rx is a private-labeled version of BlueStarRx. DIABETES SUPPORT, ANYTIME
B553OTREVEALPLUSRX150OneTouch Reveal Plus Rx is a private-labeled version of BlueStarRx. DIABETES SUPPORT, ANYTIME
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