FDA.report

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
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
NDCCalculator, Drug Dose

Product Code Classifications

CodeDeviceSpecialtyClass
NDCCalculator, Drug DoseAnesthesiology2

Premarket Submissions

SubmissionSupplement
K160673000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K160673000Insulin Algorithms SystemInsulin Algorithms2017-06-07NDC

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00860001009804PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00860001009804008600010098048600010098040860001009804

GMDN Terms

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

Contacts

PhoneEmail
(424) 218-0792info@mellitushealth.com

Regulatory Flags

DUNS number
079173054
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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