DreaMed Advisor Pro

Primary DI
07290017735016
Brand
DreaMed Advisor Pro
Company
DREAMED DIABETES LTD
Model
01.YY.XX
Catalog number
N/A
Device description
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.
Published
2018-12-30
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
QCCInsulin Pump Therapy Adjustment Calculator For Healthcare Professionals

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QCCInsulin Pump Therapy Adjustment Calculator For Healthcare ProfessionalsClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
DEN170043000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
DEN170043000DreaMed Advisor ProDreaMed Diabetes, Ltd.2018-06-12QCC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290017735016PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290017735016072900177350167290017735016

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
07290017735023endo.digital02.XX.YYN/A2022-09-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07290017735023endo.digitalDREAMED DIABETES LTDQCC2022-09-20