BlueStar

GUDID B553BLUESTAR570

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 1 or 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 18 years and older, who have type 1 or 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: 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, 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, patient-/professional-use

• Primary Device ID: B553BLUESTAR570
• NIH Device Record Key: 5abef6f7-1d6a-446a-b5fe-45963be5ff5c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BlueStar
• Version Model Number: v5.7
• Company DUNS: 021217115
• Company Name: WELLDOC, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 1-888-611-4794
• Email: connect@welldoc.com
• Phone: 1-888-611-4794
• Email: connect@welldoc.com
• Phone: 1-888-611-4794
• Email: connect@welldoc.com
• Phone: 1-888-611-4794
• Email: connect@welldoc.com
• Phone: 1-888-611-4794
• Email: connect@welldoc.com
• Phone: 1-888-611-4794
• Email: connect@welldoc.com
• Phone: 1-888-611-4794
• Email: connect@welldoc.com
• Phone: 1-888-611-4794
• Email: connect@welldoc.com
• Phone: 1-888-611-4794
• Email: connect@welldoc.com
• Phone: 1-888-611-4794
• Email: connect@welldoc.com
• Phone: 1-888-611-4794
• Email: connect@welldoc.com
• Phone: 1-888-611-4794
• Email: connect@welldoc.com
• Phone: 1-888-611-4794
• Email: connect@welldoc.com
• Phone: 1-888-611-4794
• Email: connect@welldoc.com
• Phone: 1-888-611-4794
• Email: connect@welldoc.com
• Phone: 1-888-611-4794
• Email: connect@welldoc.com
• Phone: 1-888-611-4794
• Email: connect@welldoc.com
• Phone: 1-888-611-4794
• Email: connect@welldoc.com
• Phone: 1-888-611-4794
• Email: connect@welldoc.com
• Phone: 1-888-611-4794
• Email: connect@welldoc.com
• Phone: 1-888-611-4794
• Email: connect@welldoc.com
• Phone: 1-888-611-4794
• Email: connect@welldoc.com
• Phone: 1-888-611-4794
• Email: connect@welldoc.com
• Phone: 1-888-611-4794
• Email: connect@welldoc.com
• Phone: 1-888-611-4794
• Email: connect@welldoc.com
• Phone: 1-888-611-4794
• Email: connect@welldoc.com
• Phone: 1-888-611-4794
• Email: connect@welldoc.com
• Phone: 1-888-611-4794
• Email: connect@welldoc.com
• Phone: 1-888-611-4794
• Email: connect@welldoc.com
• Phone: 1-888-611-4794
• Email: connect@welldoc.com
• Phone: 1-888-611-4794
• Email: connect@welldoc.com
• Phone: 1-888-611-4794
• Email: connect@welldoc.com
• Phone: 1-888-611-4794
• Email: connect@welldoc.com
• Phone: 1-888-611-4794
• Email: connect@welldoc.com
• Phone: 1-888-611-4794
• Email: connect@welldoc.com
• Phone: 1-888-611-4794
• Email: connect@welldoc.com
• Phone: 1-888-611-4794
• Email: connect@welldoc.com
• Phone: 1-888-611-4794
• Email: connect@welldoc.com
• Phone: 1-888-611-4794
• Email: connect@welldoc.com
• Phone: 1-888-611-4794
• Email: connect@welldoc.com
• Phone: 1-888-611-4794
• Email: connect@welldoc.com
• Phone: 1-888-611-4794
• Email: connect@welldoc.com
• Phone: 1-888-611-4794
• Email: connect@welldoc.com
• Phone: 1-888-611-4794
• Email: connect@welldoc.com
• Phone: 1-888-611-4794
• Email: connect@welldoc.com
• Phone: 1-888-611-4794
• Email: connect@welldoc.com
• Phone: 1-888-611-4794
• Email: connect@welldoc.com
• Phone: 1-888-611-4794
• Email: connect@welldoc.com
• Phone: 1-888-611-4794
• Email: connect@welldoc.com
• Phone: 1-888-611-4794
• Email: connect@welldoc.com
• Phone: 1-888-611-4794
• Email: connect@welldoc.com
• Phone: 1-888-611-4794
• Email: connect@welldoc.com
• Phone: 1-888-611-4794
• Email: connect@welldoc.com
• Phone: 1-888-611-4794
• Email: connect@welldoc.com
• Phone: 1-888-611-4794
• Email: connect@welldoc.com
• Phone: 1-888-611-4794
• Email: connect@welldoc.com
• Phone: 1-888-611-4794
• Email: connect@welldoc.com
• Phone: 1-888-611-4794
• Email: connect@welldoc.com
• Phone: 1-888-611-4794
• Email: connect@welldoc.com
• Phone: 1-888-611-4794
• Email: connect@welldoc.com
• Phone: 1-888-611-4794
• Email: connect@welldoc.com
• Phone: 1-888-611-4794
• Email: connect@welldoc.com
• Phone: 1-888-611-4794
• Email: connect@welldoc.com
• Phone: 1-888-611-4794
• Email: connect@welldoc.com
• Phone: 1-888-611-4794
• Email: connect@welldoc.com
• Phone: 1-888-611-4794
• Email: connect@welldoc.com
• Phone: 1-888-611-4794
• Email: connect@welldoc.com
• Phone: 1-888-611-4794
• Email: connect@welldoc.com
• Phone: 1-888-611-4794
• Email: connect@welldoc.com
• Phone: 1-888-611-4794
• Email: connect@welldoc.com
• Phone: 1-888-611-4794
• Email: connect@welldoc.com
• Phone: 1-888-611-4794
• Email: connect@welldoc.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B553BLUESTAR570 [Primary]

FDA Product Code

• MRZ: Accessories, Pump, Infusion

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-03-15
• Device Publish Date: 2021-03-05

On-Brand Devices [BlueStar]

• B553BLUESTAR510: DIABETES SUPPORT, ANYTIME ANYWHERE™ BlueStar is not a pill or a shot — it's a completely new
• B553BLUESTAR500: DIABETES SUPPORT, ANYTIME ANYWHERE™ BlueStar is not a pill or a shot — it's a completely new
• B553BLUESTAR420: DIABETES SUPPORT, ANYTIME ANYWHERE™ BlueStar is not a pill or a shot — it's a completely new
• B553BLUESTAR530: DIABETES SUPPORT, ANYTIME ANYWHERE™ BlueStar is not a pill or a shot — it's a completely new
• B553BLUESTAR540: DIABETES SUPPORT, ANYTIME ANYWHERE™ BlueStar is not a pill or a shot — it's a completely new
• B553BLUESTAR550: DIABETES SUPPORT, ANYTIME ANYWHERE™ BlueStar is not a pill or a shot — it's a completely new
• B553BLUESTAR560: DIABETES SUPPORT, ANYTIME ANYWHERE™ BlueStar is not a pill or a shot — it's a completely new
• B553BLUESTAR570: DIABETES SUPPORT, ANYTIME ANYWHERE™ BlueStar is not a pill or a shot — it's a completely new
• B553BLUESTAR610: DIABETES SUPPORT, ANYTIME ANYWHERE™ BlueStar is not a pill or a shot — it's a completely new
• B553BLUESTAR620: DIABETES SUPPORT, ANYTIME ANYWHERE™ BlueStar is not a pill or a shot — it's a completely new
• B553BLUESTARRX710: BlueStar® Rx is a Software as a Medical Device (SaMD) intended to be used by healthcare provide
• B553BLUESTAR710: BlueStar is a Software as a Medical Device (SaMD) intended to be used by healthcare providers (H
• B553BLUESTAR720: BlueStar is a Software as a Medical Device (SaMD) intended to be used by healthcare providers (H
• B553202006OTC0: BlueStar is a Software as a Medical Device (SaMD) intended to be used by healthcare providers (H
• B553202003OTC0: BlueStar is a Software as a Medical Device (SaMD) intended to be used by healthcare providers (H
• B553202001OTC0: BlueStar is a Software as a Medical Device (SaMD) intended to be used by healthcare providers (H