Insulin Insights™

Primary DI
00860001009804
Brand
Insulin Insights™
Company
MELLITUS HEALTH, INC.
Model
Version 1
Device description
Insulin Insights™ is a glycemic management software support program designed to provide insulin dosing recommendations to the clinician in order to adjust and maintain blood glucose levels in insulin-dependent diabetic patients within a clinician determined target range. Insulin Insights™ evaluates a set of current and cumulative patient blood glucose values together with biometric information (including age, weight, height, and gender) and suggests changes (if necessary). Insulin Insights™ is designed for use by healthcare professionals. Insulin Insights™ is indicated for use in adults and pediatric patients ages 7 and above who weigh more than 36 lbs.
Published
2019-10-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
NDCCalculator, Drug Dose

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NDCCalculator, Drug DoseAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K160673000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K160673000Insulin Algorithms SystemInsulin Algorithms2017-06-07NDC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860001009804PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860001009804008600010098048600010098040860001009804

GMDN Terms#

Term, Definition table
TermDefinition
Clinical management support softwareAn application software program intended to facilitate clinical management decisions by receiving structured patient data from electronic health records and/or manually-entered information (e.g., demographics, diagnostic, laboratory results) and returning clinical care information (e.g., reports, pedigree diagrams, reminders, suggestions, and/or links to guidelines) to a healthcare professional responsible for patient care. Otherwise known as clinical decision support (CDS) software, it may be a locally-installed program, web-based, or mobile application. It is not primarily intended to manage diagnostic/patient images.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
(424) 218-0792info@mellitushealth.com

Regulatory Flags#

DUNS number
079173054
Device count
1

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Primary DI, Brand, Company table
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