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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.
v7.X
In Commercial Distribution
- B553202001OTC0 ()
- Home pharmaceutical management support software
Conifer Connect includes Conifer Connect Diabetes and Conifer Connect Diabetes Rx, which 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. Conifer Connect Diabetes and Conifer Connect Diabetes Rx are intended to assist patients in managing their diabetes with guidance from their providers. Conifer Connect Diabetes Rx requires a prescription.
WELLDOC, INC.
v1.X
In Commercial Distribution
- B552202153OTC0 ()
- Home pharmaceutical management support software
GlucoCare Intensive Glycemic Control System
Pronia Medical Systems Inc.
2.X
In Commercial Distribution
- G111GCR2 ()
- Clinical management support software
Rapid Platform plus cleared indications for Rapid version 6.x
Ischemaview, Inc.
6.x
In Commercial Distribution
- B761R60 ()
- Radiological PACS software
A lightweight folding wheelchair that provides mobility and portability for those Adults that weigh 140 kilograms (309 lbs.) or less.
SUNRISE MEDICAL (US) LLC
QS5 X
In Commercial Distribution
- 00016958059526 ()
EIF7
- Push-rim manual wheelchair, non-bariatric
The Globus Volta X device is a programmable electro stimulator with multiple uses:
Powered Muscle Stimulators, Transcutaneous Electrical Nerve Stimulator.
Premodulated Current Therapy Stimulator, and Microcurrent Therapy Stimulator.
DOMINO SRL
VOLTA X
In Commercial Distribution
- 08032625822868 ()
G7096
- Physical therapy transcutaneous neuromuscular electrical stimulation system
No Description
PHILIPS FRANCE COMMERCIAL
2.4.x
In Commercial Distribution
- G637CEA0 ()
- Cardiopulmonary physiological parameter analysis software
Calculation Services 1.X
CAREFUSION 303, INC.
1.X
In Commercial Distribution
- 10885403510489 ()
- Infusion pump medication-dosage application software
No Description
Poskom Co., Ltd.
Rextar X
In Commercial Distribution
- 08800040900047 ()
- Diagnostic x-ray system generator, portable
No Description
MILVUE
V1.1.x
In Commercial Distribution
- 03770024774047 ()
- Radiological PACS software