Bluestar

GUDID B553BLUESTAR720

BlueStar 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 is intended to assist patients in managing their diabetes with guidance from their providers BlueStar® 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 is intended to provide secure capture, storage, and transmission of glucose data as well as information to aid in diabetes self-management. BlueStar analyzes, and reports glucose test results and supports medication adherence. In addition, BlueStar 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.

Home pharmaceutical management support software

• Primary Device ID: B553BLUESTAR720
• NIH Device Record Key: e0cbbff5-f7f8-420b-a148-8a2ab09bddaa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bluestar
• Version Model Number: v7.2
• 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: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B553BLUESTAR720 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K203434

FDA Product Code

• NDC: Calculator, Drug Dose

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2023-10-18
• Device Publish Date: 2023-01-24

On-Brand Devices [Bluestar ]

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• 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