Insulin Insights™

Basic Information

• Brand Name: Insulin Insights™
• Primary DI: 00860001009804
• Version / Model: Version 1
• Company Name: MELLITUS HEALTH, INC.
• Labeler DUNS: 079173054
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-10-23
• Public Version: 4
• Public Version Date: 2024-10-21
• Public Version Status: Update
• Public Device Record Key: 6351040a-4673-44d2-a996-a540d4523e8a

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.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NDC	Calculator, Drug Dose	Anesthesiology	868.1890	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61087	Clinical management support software	An application software program intended to facilitate clinical management decisions by receiving 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, referral pathways, pedigree diagrams, reminders, post-therapy prognosis/risk score, anaesthesia/pharmaceutical dosage, and/or links to guidelines) to a healthcare professional responsible for patient care; it is not primarily intended to analyse or manage diagnostic/patient images. Also known as clinical decision support (CDS) software, it may be a locally-installed program, web-based, or mobile application.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00860001009804	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K160673	000