endo.digital

Primary DI
07290017735023
Brand
endo.digital
Company
DREAMED DIABETES LTD
Model
02.XX.YY
Catalog number
N/A
Device description
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.
Published
2022-09-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
OUGMedical Device Data System
PHVContinuous Glucose Monitor Retrospective Data Analysis Software
QCCInsulin Pump Therapy Adjustment Calculator For Healthcare Professionals

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OUGMedical Device Data SystemGeneral Hospital1
PHVContinuous Glucose Monitor Retrospective Data Analysis SoftwareClinical Chemistry1
QCCInsulin Pump Therapy Adjustment Calculator For Healthcare ProfessionalsClinical Chemistry2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290017735023PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290017735023072900177350237290017735023

GMDN Terms#

Term, Definition table
TermDefinition
Ambulatory insulin infusion pump remote control/blood glucose analyserA portable electronic device designed to: 1) remotely control an electronic ambulatory insulin infusion pump; and 2) measure blood glucose levels to aid a diabetes mellitus patient in self-management of insulin therapy. It consists of a wireless unit that interfaces with the pump (not included) to control and program pump functions and receive pump status information, and which incorporates a blood glucose meter and built-in test strip port for the in vitro quantitative measurement of glucose in harvested capillary blood.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
600230110
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290017735030Diary Mobile App02.XX.YYN/A2022-10-26
07290017735016DreaMed Advisor Pro01.YY.XXN/A2018-12-30

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