MELLITUS HEALTH, INC.

Address:370 S. Doheny Drive,Beverly Hills,CA,90211,US

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Calculator, Drug Dose (NDC) (1)

Premarket Exempt

Clear

Insulin Insights™ - 00860001009804 Catalog Number :

Device Description : Insulin Insights™ is a glycemic management software support program designed to 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 Class : 2

Duns Number: 079173054

Premarket Exempt : No

Product Code : NDC

Prescription Use : No

Device Count : 1

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