Diary Mobile App N/A

GUDID 07290017735030

The Diary is a mobile app intended for use by people with diabetes, in order to log, track and share blood glucose levels, insulin delivery, physical activity, as well as carbs and meal information as part of the endo.digital Platform used by their healthcare provider. Diary also enables people to communicate with their healthcare provider. The Diary mobile app also enables the patient to see their insulin treatment recommendations provided by their healthcare provider. The insulin treatment plan is approved by your healthcare provider and he/she may have been assisted by the endo.digital algorithm before approving the plan. The Diary Mobile app is suited for both iPhone and Android users. The Bolus Calculator, a component of the DreaMed Diary App, is a diabetes management tool for people with type 1 diabetes above the age of 6 and type 2 diabetes above the age of 10, who use subcutaneous insulin injections therapy (not for pump use). This tool can help calculate their rapid acting analogs for insulin bolus doses based on user-entered blood glucose and/or meal information. The initial setup of the user’s treatment plans, and bolus calculator settings must be performed by a healthcare provider.

DREAMED DIABETES LTD

Clinical management support software

• Primary Device ID: 07290017735030
• NIH Device Record Key: 10dd265c-8d14-4add-a4be-0612bc8b5f89
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Diary Mobile App
• Version Model Number: 02.XX.YY
• 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	07290017735030 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K210561

FDA Product Code

• NDC: Calculator, Drug Dose

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-11-03
• Device Publish Date: 2022-10-26

Devices Manufactured by DREAMED DIABETES LTD

• 07290017735030 - Diary Mobile App: 2022-11-03The Diary is a mobile app intended for use by people with diabetes, in order to log, track and share blood glucose levels, insulin delivery, physical activity, as well as carbs and meal information as part of the endo.digital Platform used by their healthcare provider. Diary also enables people to communicate with their healthcare provider. The Diary mobile app also enables the patient to see their insulin treatment recommendations provided by their healthcare provider. The insulin treatment plan is approved by your healthcare provider and he/she may have been assisted by the endo.digital algorithm before approving the plan. The Diary Mobile app is suited for both iPhone and Android users. The Bolus Calculator, a component of the DreaMed Diary App, is a diabetes management tool for people with type 1 diabetes above the age of 6 and type 2 diabetes above the age of 10, who use subcutaneous insulin injections therapy (not for pump use). This tool can help calculate their rapid acting analogs for insulin bolus doses based on user-entered blood glucose and/or meal information. The initial setup of the user’s treatment plans, and bolus calculator settings must be performed by a healthcare provider.
• 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: 2020-01-22 DreaMed Advisor Pro is a software product that is designed to provide advice on the control and management of diabetes for insul