BlueStar

GUDID B553BLUESTAR420

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.

Pharmaceutical management support software
Primary Device IDB553BLUESTAR420
NIH Device Record Keyb7ec00d9-fd49-4c20-8058-49df48812817
Commercial Distribution Discontinuation2018-06-13
Commercial Distribution StatusNot in Commercial Distribution
Brand NameBlueStar
Version Model Numberv4.2
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-Counterfalse

Customer Support Contacts

Phone888-611-4794
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Phone888-611-4794
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Emailconnect@welldoc.com
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Phone888-611-4794
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Phone1-888-611-4794
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Emailconnect@welldoc.com
Phone888-611-4794
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Emailconnect@welldoc.com
Phone888-611-4794
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Emailconnect@welldoc.com
Phone888-611-4794
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Emailconnect@welldoc.com
Phone888-611-4794
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Emailconnect@welldoc.com
Phone888-611-4794
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Emailconnect@welldoc.com
Phone888-611-4794
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Emailconnect@welldoc.com
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Emailconnect@welldoc.com
Phone888-611-4794
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Phone888-611-4794
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Phone1-888-611-4794
Emailconnect@welldoc.com
Phone888-611-4794
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Phone1-888-611-4794
Emailconnect@welldoc.com
Phone888-611-4794
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Phone1-888-611-4794
Emailconnect@welldoc.com
Phone888-611-4794
Emailxxx@xx.xx
Phone1-888-611-4794
Emailconnect@welldoc.com
Phone888-611-4794
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Emailconnect@welldoc.com
Phone888-611-4794
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Emailconnect@welldoc.com
Phone888-611-4794
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Emailconnect@welldoc.com
Phone888-611-4794
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Emailconnect@welldoc.com
Phone888-611-4794
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Phone888-611-4794
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Phone888-611-4794
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Phone888-611-4794
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Phone888-611-4794
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Emailconnect@welldoc.com
Phone888-611-4794
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Emailconnect@welldoc.com
Phone888-611-4794
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Emailconnect@welldoc.com
Phone888-611-4794
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Emailconnect@welldoc.com
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Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB553BLUESTAR420 [Previous]
HIBCCB553BLUESTAR430 [Primary]

FDA Product Code

MRZAccessories, Pump, Infusion

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-05-07
Device Publish Date2018-06-04

On-Brand Devices [BlueStar]

B553BLUESTAR510DIABETES SUPPORT, ANYTIME ANYWHERE™ BlueStar is not a pill or a shot — it's a completely new
B553BLUESTAR500DIABETES SUPPORT, ANYTIME ANYWHERE™ BlueStar is not a pill or a shot — it's a completely new
B553BLUESTAR420DIABETES SUPPORT, ANYTIME ANYWHERE™ BlueStar is not a pill or a shot — it's a completely new
B553BLUESTAR530DIABETES SUPPORT, ANYTIME ANYWHERE™ BlueStar is not a pill or a shot — it's a completely new
B553BLUESTAR540DIABETES SUPPORT, ANYTIME ANYWHERE™ BlueStar is not a pill or a shot — it's a completely new
B553BLUESTAR550DIABETES SUPPORT, ANYTIME ANYWHERE™ BlueStar is not a pill or a shot — it's a completely new
B553BLUESTAR560DIABETES SUPPORT, ANYTIME ANYWHERE™ BlueStar is not a pill or a shot — it's a completely new
B553BLUESTAR570DIABETES SUPPORT, ANYTIME ANYWHERE™ BlueStar is not a pill or a shot — it's a completely new
B553BLUESTAR610DIABETES SUPPORT, ANYTIME ANYWHERE™ BlueStar is not a pill or a shot — it's a completely new
B553BLUESTAR620DIABETES SUPPORT, ANYTIME ANYWHERE™ BlueStar is not a pill or a shot — it's a completely new
B553BLUESTARRX710BlueStar® Rx is a Software as a Medical Device (SaMD) intended to be used by healthcare provide
B553BLUESTAR710BlueStar is a Software as a Medical Device (SaMD) intended to be used by healthcare providers (H
B553BLUESTAR720BlueStar is a Software as a Medical Device (SaMD) intended to be used by healthcare providers (H
B553202006OTC0BlueStar is a Software as a Medical Device (SaMD) intended to be used by healthcare providers (H
B553202003OTC0BlueStar is a Software as a Medical Device (SaMD) intended to be used by healthcare providers (H
B553202001OTC0BlueStar is a Software as a Medical Device (SaMD) intended to be used by healthcare providers (H

Trademark Results [BlueStar]

Mark Image

Registration | Serial
Company
Trademark
Application Date
BLUESTAR
BLUESTAR
98415258 not registered Live/Pending
Ameritas Life Insurance Corp.
2024-02-21
BLUESTAR
BLUESTAR
98338874 not registered Live/Pending
Howl, Robert C
2024-01-02
BLUESTAR
BLUESTAR
97322901 not registered Live/Pending
CONVERSION ENERGY SYSTEMS, INC
2022-03-21
BLUESTAR
BLUESTAR
97091136 not registered Live/Pending
Liang, Difa
2021-10-25
BLUESTAR
BLUESTAR
90579443 not registered Live/Pending
United Radio Incorporated
2021-03-15
BLUESTAR
BLUESTAR
90579431 not registered Live/Pending
United Radio Incorporated
2021-03-15
BLUESTAR
BLUESTAR
90579406 not registered Live/Pending
United Radio Incorporated
2021-03-15
BLUESTAR
BLUESTAR
90489770 not registered Live/Pending
Vernon Sales Inc.
2021-01-26
BLUESTAR
BLUESTAR
90083608 not registered Live/Pending
Blue Star B.V.
2020-07-30
BLUESTAR
BLUESTAR
90083440 not registered Live/Pending
Blue Star B.V.
2020-07-30
BLUESTAR
BLUESTAR
88904887 not registered Live/Pending
United Radio Incorporated
2020-05-07
BLUESTAR
BLUESTAR
88904878 not registered Live/Pending
United Radio Incorporated
2020-05-07
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