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WELLDOC, INC. v7.1 Bluestar

Company Name

WELLDOC, INC.

Catalog Number

v7.1

UOMs

Each

Description

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.

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Additional Details

Device Identifier

B553BLUESTARRX710

Is RX

Yes

Is Over the Counter

No

Requires Sterilization

No

Is Sterile

No

Is Single Use

Yes

Categories

Barcode Mapping

Unit of Measurement	Eaches	GTIN
Each	1	B553BLUESTARRX710