OneTouch Reveal Plus

GUDID B553OTREVEALPLUS120

OneTouch Reveal Plus is a private-labeled version of BlueStarRx. 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 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 21 years and older, who have 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: 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.

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Primary Device IDB553OTREVEALPLUS120
NIH Device Record Key8db7cd4b-9864-4643-962e-d1ebe0d0a4aa
Commercial Distribution StatusIn Commercial Distribution
Brand NameOneTouch Reveal Plus
Version Model Numberv1.2
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

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB553OTREVEALPLUS120 [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 Date2019-10-30
Device Publish Date2019-10-22

On-Brand Devices [OneTouch Reveal Plus]

B553OTREVEALPLUS130OneTouch Reveal Plus is a private-labeled version of BlueStarRx. DIABETES SUPPORT, ANYTIME ANY
B553OTREVEALPLUS120OneTouch Reveal Plus is a private-labeled version of BlueStarRx. DIABETES SUPPORT, ANYTIME ANY
B553OTREVEALPLUS140OneTouch Reveal Plus is a private-labeled version of BlueStar. DIABETES SUPPORT, ANYTIME ANYWH
B553OTREVEALPLUS150OneTouch Reveal Plus is a private-labeled version of BlueStar. DIABETES SUPPORT, ANYTIME ANYWH

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