DREAMED DIABETES LTD

Address:5 Mota Gur Street,Petah Tikva Tel Aviv,IL

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Insulin Pump Therapy Adjustment Calculator For Healthcare Professionals (QCC) (2) Continuous Glucose Monitor Retrospective Data Analysis Software (PHV) (1) Medical Device Data System (OUG) (1)

Premarket Exempt

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DreaMed Advisor Pro - 07290017735016 Catalog Number : N/A

Device Description : DreaMed Advisor Pro is a software device that is designed to provide insulin the DreaMed Advisor Pro is a software device that is designed to provide insulin therapy adjustment recommendations to physicians to assist in the management of diabetes for patients with Type 1 diabetes using an insulin pump, a continuous glucose monitoring (CGM) system and self-management blood glucose meter (SMBG).The DreaMed Advisor Pro gathers and analyzes information inputted through qualified Diabetes Management Systems (DMS), which collects biological input information from various diabetes devices. Diabetes device information required and used by DreaMed Advisor Pro includes glucose readings (either CGM sensor readings and/or capillary blood glucose measurements), insulin dosing logs, and meal data during daily routine care.Following data collection and analysis, the DreaMed Advisor Pro generates results containing summary data and recommendations for adjustments to the patient’sinsulin therapy parameters, including basal insulin delivery rate(s), insulin to carbohydrate ratio and correction factor (insulin sensitivity). DreaMed Advisor Pro may also advise behavioral changes. Results are sent to a qualified Diabetes Management Systems, which displays results to physicians and a report provided by DreaMed Diabetes. The physician can approve, reject or change the recommendations and issue the updated treatment plan to the patient.

Device Class : 2

Duns Number: 600230110

Premarket Exempt : No

Product Code : QCC

Prescription Use : Yes

Device Count : 1

endo.digital - 07290017735023 Catalog Number : N/A

Device Description : endo.digital platform is a software device that is designed to provide insulin t endo.digital platform is a software device that is designed to provide insulin therapy adjustment recommendations to physicians to assist in the management of diabetes for patients with Type 1 diabetes using an insulin pump, a continuous glucose monitoring (CGM) system and self-management blood glucose meter (SMBG) and to patients with Type 2 diabetes on basal-bolus therapy via multiple daily injections (MDI), a continuous glucose monitoring (CGM) system and/or self-management blood glucose meter (SMBG). endo.digital gathers and analyses information inputted through the endo.digital Uploader or qualified Diabetes Management Systems (DMS), which collects biological input information from various diabetes devices. Diabetes device information required and used by endo.digital includes glucose readings (either CGM sensor readings and/or capillary blood glucose measurements), insulin dosing logs, and meal data during daily routine care. Following data collection and analysis, the endo.digital platform generates results containing summary data and recommendations for adjustments to the patient’s insulin therapy parameters, including a basal and bolus plan. endo.digital may also advise behavioral changes. The physician can approve, reject or change the recommendations and issue the updated treatment plan to the patients.

Device Class : 1

Duns Number: 600230110

Premarket Exempt : No

Product Code : OUG, PHV, QCC

Prescription Use : Yes

Device Count : 1

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