MONARCH MEDICAL TECHNOLOGIES LLC

Address:112 S. Tryon Street,Charlotte,NC,28284,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

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EndoTool - 00860003340608 Catalog Number :

Device Description : EndoTool is a glucose management software system, designed for use by healthcare EndoTool is a glucose management software system, designed for use by healthcare professionals in all patient care settings to recommend intravenous and subcutaneous transition dosing, as well as carbohydrates. Evaluating current and cumulative glucose levels, the software adjusts and maintains the glucose level within a configurable clinician-determined target range. The system is indicated for use in adult and pediatric patients ages 2 years and above, who weigh 12 kgs. or more. EndoTool logic is not a substitute for, but rather an adjunct to clinical reasoning. No medical decision should be based solely on the recommended guidance provided by this software system.

Device Class : 2

Duns Number: 078665793

Premarket Exempt : No

Product Code : NDC

Prescription Use : Yes

Device Count : 1

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