Bluestar

GUDID B553BLUESTARRX710

BlueStar® Rx is a Software as a Medical Device (SaMD) intended to be used by healthcare providers (HCPs) and their patients – aged 18 years and older - who have type 1 or type 2 diabetes. BlueStar Rx is intended to assist patients in managing their diabetes with guidance from their providers. BlueStar® Rx is indicated for use by healthcare providers (HCPs) and their patients – aged 18 years and older - who have type 1 or type 2 diabetes. BlueStar Rx is intended to provide secure capture, storage, and transmission of glucose data as well as information to aid in diabetes self-management. BlueStar Rx analyzes, and reports glucose test results and supports medication adherence. In addition, BlueStar Rx provides coaching messages (motivational, behavioral, and educational) based on real-time glucose values and trends. It includes software intended for use on mobile phones or personal computers in the home or in professional healthcare settings. The software also allows for entry of other diabetes-related healthcare information and provides educational information. BlueStar is not intended to replace the care provided by a licensed healthcare professional, including prescriptions, diagnosis, or treatment.

WELLDOC, INC.

Pharmaceutical management support software, patient-/professional-use Pharmaceutical management support software, patient-/professional-use Pharmaceutical management support software, patient-/professional-use Pharmaceutical management support software, patient-/professional-use Pharmaceutical management support software, patient-/professional-use Pharmaceutical management support software, patient-/professional-use Pharmaceutical management support software, patient-/professional-use Pharmaceutical management support software, patient-/professional-use Pharmaceutical management support software, patient-/professional-use Pharmaceutical management support software, patient-/professional-use Pharmaceutical management support software, patient-/professional-use Pharmaceutical management support software, patient-/professional-use Pharmaceutical management support software, patient-/professional-use Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software

• Primary Device ID: B553BLUESTARRX710
• NIH Device Record Key: d12cbefa-323c-4089-a7de-9bfd30e4e3f4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bluestar
• Version Model Number: v7.1
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 18884503664
• Email: connect@welldoc.com
• Phone: 18884503664
• Email: connect@welldoc.com
• Phone: 18884503664
• Email: connect@welldoc.com
• Phone: 18884503664
• Email: connect@welldoc.com
• Phone: 18884503664
• Email: connect@welldoc.com
• Phone: 18884503664
• Email: connect@welldoc.com
• Phone: 18884503664
• Email: connect@welldoc.com
• Phone: 18884503664
• Email: connect@welldoc.com
• Phone: 18884503664
• Email: connect@welldoc.com
• Phone: 18884503664
• Email: connect@welldoc.com
• Phone: 18884503664
• Email: connect@welldoc.com
• Phone: 18884503664
• Email: connect@welldoc.com
• Phone: 18884503664
• Email: connect@welldoc.com
• Phone: 18884503664
• Email: connect@welldoc.com
• Phone: 18884503664
• Email: connect@welldoc.com
• Phone: 18884503664
• Email: connect@welldoc.com
• Phone: 18884503664
• Email: connect@welldoc.com
• Phone: 18884503664
• Email: connect@welldoc.com
• Phone: 18884503664
• Email: connect@welldoc.com
• Phone: 18884503664
• Email: connect@welldoc.com
• Phone: 18884503664
• Email: connect@welldoc.com
• Phone: 18884503664
• Email: connect@welldoc.com
• Phone: 18884503664
• Email: connect@welldoc.com
• Phone: 18884503664
• Email: connect@welldoc.com
• Phone: 18884503664
• Email: connect@welldoc.com
• Phone: 18884503664
• Email: connect@welldoc.com
• Phone: 18884503664
• Email: connect@welldoc.com
• Phone: 18884503664
• Email: connect@welldoc.com
• Phone: 18884503664
• Email: connect@welldoc.com
• Phone: 18884503664
• Email: connect@welldoc.com
• Phone: 18884503664
• Email: connect@welldoc.com
• Phone: 18884503664
• Email: connect@welldoc.com
• Phone: 18884503664
• Email: connect@welldoc.com
• Phone: 18884503664
• Email: connect@welldoc.com
• Phone: 18884503664
• Email: connect@welldoc.com
• Phone: 18884503664
• Email: connect@welldoc.com
• Phone: 18884503664
• Email: connect@welldoc.com
• Phone: 18884503664
• Email: connect@welldoc.com
• Phone: 18884503664
• Email: connect@welldoc.com
• Phone: 18884503664
• Email: connect@welldoc.com
• Phone: 18884503664
• Email: connect@welldoc.com
• Phone: 18884503664
• Email: connect@welldoc.com
• Phone: 18884503664
• Email: connect@welldoc.com
• Phone: 18884503664
• Email: connect@welldoc.com
• Phone: 18884503664
• Email: connect@welldoc.com
• Phone: 18884503664
• Email: connect@welldoc.com
• Phone: 18884503664
• Email: connect@welldoc.com
• Phone: 18884503664
• Email: connect@welldoc.com
• Phone: 18884503664
• Email: connect@welldoc.com
• Phone: 18884503664
• Email: connect@welldoc.com
• Phone: 18884503664
• Email: connect@welldoc.com
• Phone: 18884503664
• Email: connect@welldoc.com
• Phone: 18884503664
• Email: connect@welldoc.com
• Phone: 18884503664
• Email: connect@welldoc.com
• Phone: 18884503664
• Email: connect@welldoc.com
• Phone: 18884503664
• Email: connect@welldoc.com
• Phone: 18884503664
• Email: connect@welldoc.com
• Phone: 18884503664
• Email: connect@welldoc.com
• Phone: 18884503664
• Email: connect@welldoc.com
• Phone: 18884503664
• Email: connect@welldoc.com
• Phone: 18884503664
• Email: connect@welldoc.com
• Phone: 18884503664
• Email: connect@welldoc.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B553BLUESTARRX710 [Primary]

FDA Product Code

• NDC: Calculator, Drug Dose

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: 2022-05-06
• Device Publish Date: 2022-04-28

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