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

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Primary Device ID07290017735030
NIH Device Record Key10dd265c-8d14-4add-a4be-0612bc8b5f89
Commercial Distribution StatusIn Commercial Distribution
Brand NameDiary Mobile App
Version Model Number02.XX.YY
Catalog NumberN/A
Company DUNS600230110
Company NameDREAMED DIABETES LTD
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS107290017735030 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NDCCalculator, Drug Dose

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-11-03
Device Publish Date2022-10-26

Devices Manufactured by DREAMED DIABETES LTD

07290017735030 - Diary Mobile App2022-11-03The 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 App2022-11-03 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.digital2022-09-28 endo.digital platform is a software device that is designed to provide insulin therapy adjustment recommendations to physicians
07290017735016 - DreaMed Advisor Pro2020-01-22 DreaMed Advisor Pro is a software product that is designed to provide advice on the control and management of diabetes for insul

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