DreaMed Advisor Pro N/A

GUDID 07290017735016

DreaMed Advisor Pro is a software product that is designed to provide advice on the control and management of diabetes for insulin pump-treated type 1 diabetic patients and their physician. The Advisor Pro Algorithm gathers and analyzes information from existing 3rd Party Diabetes Management Systems which includes glucose readings (sensor readings or capillary blood glucose measurements), insulin dosing and meal data during daily routine home care. This information is being sent to the Advisor Pro Algorithm from a 3rd Party Diabetes Management System which gathers the information from the various diabetes devices. Following data collection and analysis, the Advisor Pro Algorithm generates analysis results containing summary data and recommendations regarding the patient’s basal plan, carbohydrate ratio, correction factor, active insulin times and glucose targets to the physician. The algorithm may also advice behavioral changes. These analysis results are sent to the 3rd Party Diabetes Management Systems in a raw data format. That raw data is formatted by the 3rd Party Diabetes Management Systems to be displayed to the physician based on guidelines and a sample report provided by DreaMed Diabetes. The physician can approve, reject or change the recommendations and issue the updated treatment plan to the patient (accomplished by the 3rd Party Diabetes Management Systems)

DREAMED DIABETES LTD

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• Primary Device ID: 07290017735016
• NIH Device Record Key: a0519c32-0986-499a-8513-b742f7e5d46a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DreaMed Advisor Pro
• Version Model Number: 01.07.XX
• Catalog Number: N/A
• Company DUNS: 600230110
• Company Name: DREAMED DIABETES LTD
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290017735016 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• deNovo: DEN170043

FDA Product Code

• QCC: Insulin Pump Therapy Adjustment Calculator For Healthcare Professionals

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-01-22
• Device Publish Date: 2018-12-30

Devices Manufactured by DREAMED DIABETES LTD

• 07290017735030 - Diary Mobile App: 2022-11-03 The Diary is a mobile app intended for use by people with diabetes, in order to log, track and share blood glucose levels, insul
• 07290017735023 - endo.digital: 2022-09-28 endo.digital platform is a software device that is designed to provide insulin therapy adjustment recommendations to physicians
• 07290017735016 - DreaMed Advisor Pro: 2020-01-22DreaMed Advisor Pro is a software product that is designed to provide advice on the control and management of diabetes for insulin pump-treated type 1 diabetic patients and their physician. The Advisor Pro Algorithm gathers and analyzes information from existing 3rd Party Diabetes Management Systems which includes glucose readings (sensor readings or capillary blood glucose measurements), insulin dosing and meal data during daily routine home care. This information is being sent to the Advisor Pro Algorithm from a 3rd Party Diabetes Management System which gathers the information from the various diabetes devices. Following data collection and analysis, the Advisor Pro Algorithm generates analysis results containing summary data and recommendations regarding the patient’s basal plan, carbohydrate ratio, correction factor, active insulin times and glucose targets to the physician. The algorithm may also advice behavioral changes. These analysis results are sent to the 3rd Party Diabetes Management Systems in a raw data format. That raw data is formatted by the 3rd Party Diabetes Management Systems to be displayed to the physician based on guidelines and a sample report provided by DreaMed Diabetes. The physician can approve, reject or change the recommendations and issue the updated treatment plan to the patient (accomplished by the 3rd Party Diabetes Management Systems)
• 07290017735016 - DreaMed Advisor Pro: 2020-01-22 DreaMed Advisor Pro is a software product that is designed to provide advice on the control and management of diabetes for insul