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MONARCH MEDICAL TECHNOLOGIES

EndoTool IV · General and Plastic Surgery

510(k): 3 Recall: 1 UDI: 2 MAUDE: 4 Class.: 0

510(k) Clearances (3)

2024-12-11

Substantially Equivalent

2020-08-07

Substantially Equivalent

2020-03-17

Substantially Equivalent

UDI Registrations (2)

EndoTool IV

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 …

EndoTool IV

EndoTool IV is a glucose management software system used by healthcare professionals in all inpatient care settings for adult and pediatric patients aged two years and above who weigh 12 kgs. or more. EndoTool adjusts and maintains a patient’s glucose level within a configurable clinician-determined target range by recommending patient-specific intravenous insulin dosing, carbohydrate dosing for…

MAUDE Adverse Events (4)

Malfunction
20200304
Malfunction
20171215
Injury
Malfunction