BlueStarRx

GUDID B553BLUESTARRX420

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 IDB553BLUESTARRX420
NIH Device Record Keyd3df923e-07a0-4aee-a76d-a8a6c4e9cda3
Commercial Distribution Discontinuation2018-06-13
Commercial Distribution StatusNot in Commercial Distribution
Brand NameBlueStarRx
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 Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

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Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB553BLUESTARRX420 [Previous]
HIBCCB553BLUESTARRX430 [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 StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-05-07
Device Publish Date2018-06-04

On-Brand Devices [BlueStarRx]

B553BLUESTARRX510DIABETES SUPPORT, ANYTIME ANYWHERE™ BlueStarRx is not a pill or a shot — it's a completely n
B553BLUESTARRX500DIABETES SUPPORT, ANYTIME ANYWHERE™ BlueStarRx is not a pill or a shot — it's a completely n
B553BLUESTARRX420DIABETES SUPPORT, ANYTIME ANYWHERE™ BlueStar is not a pill or a shot — it's a completely new
B553BLUESTARRX530DIABETES SUPPORT, ANYTIME ANYWHERE™ BlueStarRx is not a pill or a shot — it's a completely n
B553BLUESTARRX540DIABETES SUPPORT, ANYTIME ANYWHERE™ BlueStarRx is not a pill or a shot — it's a completely n
B553BLUESTARRX550DIABETES SUPPORT, ANYTIME ANYWHERE™ BlueStarRx is not a pill or a shot — it's a completely n
B553BLUESTARRX560DIABETES SUPPORT, ANYTIME ANYWHERE™ BlueStarRx is not a pill or a shot — it's a completely n
B553BLUESTARRX570DIABETES SUPPORT, ANYTIME ANYWHERE™ BlueStarRx is not a pill or a shot — it's a completely n
B553BLUESTARRX610DIABETES SUPPORT, ANYTIME ANYWHERE™ BlueStarRx is not a pill or a shot — it's a completely n
B553BLUESTARRX620DIABETES SUPPORT, ANYTIME ANYWHERE™ BlueStarRx is not a pill or a shot — it's a completely n
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