NUANCE MEDICAL, LLC 90003 EarClear Rx

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.

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.

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.

Healthfirst Cares 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. Healthfirst Cares Rx is intended to provide secure capture, storage, and transmission of glucose data as well as information to aid in diabetes self-management. Healthfirst Cares Rx analyzes, and reports glucose test results and supports medication adherence. In addition, Healthfirst Cares 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. The following Healthfirst Cares Rx insulin management feature is for prescription use only: For bolus insulin users with type 1 or type 2 diabetes, Healthfirst Cares Rx includes an insulin dose calculator* to allow patients to use their prescribed regimen to calculate a dose of bolus insulin for a given amount of carbohydrates and/or glucose value. Healthfirst Cares Rx is not intended to replace the care provided by a licensed healthcare professional, including prescriptions, diagnosis, or treatment.

Cap for hair growth, photobiomodulation. 312 diode device.

First Aid Kit Wihout Drug (Content : Adhesive bandages in a variety of different sizes and shapes + Non-adherent sterile Gauze Pad + Cleansing wipe (with alcohol)) This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.

The Test of Variables of Attention (T.O.V.A.) kit contains the hardware and software necessary to install and administer the T.O.V.A. continuous performance test. The T.O.V.A. provides healthcare professionals with objective measurements of attention and inhibitory control. The visual T.O.V.A. aids in the assessment of, and evaluation of treatment for, attention deficits, including attention-deficit/hyperactivity disorder (ADHD). The auditory T.O.V.A. aids in the assessment of attention deficits, including ADHD. T.O.V.A. results should only be interpreted by qualified professionals.

STERIL-PEEL TUBING/ROLL 9" X 656'

STERIL-PEEL TUBING/ROLL 4" X 656'

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.

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.

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.

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.

Healthfirst Cares 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. Healthfirst Cares Rx is intended to provide secure capture, storage, and transmission of glucose data as well as information to aid in diabetes self-management. Healthfirst Cares Rx analyzes, and reports glucose test results and supports medication adherence. In addition, Healthfirst Cares 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. The following Healthfirst Cares Rx insulin management feature is for prescription use only: For bolus insulin users with type 1 or type 2 diabetes, Healthfirst Cares Rx includes an insulin dose calculator* to allow patients to use their prescribed regimen to calculate a dose of bolus insulin for a given amount of carbohydrates and/or glucose value. Healthfirst Cares Rx is not intended to replace the care provided by a licensed healthcare professional, including prescriptions, diagnosis, or treatment.