DEVICE: BlueStar (B553BLUESTAR510)
Device Identifier (DI) Information
BlueStar
v5.1
In Commercial Distribution
WELLDOC, INC.
v5.1
In Commercial Distribution
WELLDOC, INC.
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
Device Characteristics
Labeling does not contain MRI Safety Information | |
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No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
61215 | Home pharmaceutical management support software |
A software package intended to be used by patients at home, and healthcare professionals in a clinical setting, to facilitate therapeutic pharmaceutical management decisions (e.g., dosage) by providing suggested regimes for individual patients based on their physical and laboratory data. It is intended to be used on a non-medical computerized device (e.g., to be used on mobile devices at point-of-care); it is not intended to support anaesthesia administration.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
MRZ | Accessories, Pump, Infusion |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
bd48e088-d434-40e2-a9ff-3ff577a25e42
November 03, 2023
7
January 18, 2019
November 03, 2023
7
January 18, 2019
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
1-888-611-4794
connect@welldoc.com
connect@welldoc.com