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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
SW000795 NGTELL7x-S Telligence Bridge Software, v7.4+
Ascom (Sweden) AB
7.x
In Commercial Distribution
- 17350088671426 ()
- Nurse call system
Endodrill Drive System is to be used with Endodrill Biopsy Instrument GI . Endodrill System is a surgical instrument used together with a flexible ultrasound endoscope to collect tissue for histological examination.
Bibbinstruments AB
Model X
In Commercial Distribution
- 17340179900078 ()
3000-01
- General-purpose endoscopic needle, single-use
NEEDLE HOLDER TROUTMAN W/LOCK
Bausch & Lomb Incorporated
E3839 X
In Commercial Distribution
- 00757770429882 ()
- Suturing needle holder, reusable
NEEDLE HOLDER CURVED STORZ
Bausch & Lomb Incorporated
E3797 X
In Commercial Distribution
- 00757770415205 ()
- Suturing needle holder, reusable
No Description
H & O Equipments SA
CryoProbe X+
In Commercial Distribution
- 15407008481114 ()
S-HO-CXPRP-02
- General cryosurgical system, cryogen gas, mechanical
No Description
H & O Equipments SA
CryoProbe X+
In Commercial Distribution
- 15407008481107 ()
S-HO-CXPRP-01
- General cryosurgical system, cryogen gas, mechanical
Audyx is an online audiology platform for patients care. It runs on a computing device connected to the Internet as well as to an electro-acoustic system to produce controlled signals to perform audiometric evaluation and to assist in the diagnosis of otological disorders
KOALYS TECHNOLOGIES LTD
2.X
In Commercial Distribution
- 07290017820019 ()
N/A
- Tone audiometer
Dental ultrasonic surgical system
Guilin Woodpecker Medical Instrument Co., Ltd.
PIEZOART X
In Commercial Distribution
- 06944843605807 ()
- Dental ultrasonic surgical system