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510(k) Data Aggregation
K Number
K053137Device Name
ENDOTOOL DRUG DOSE CALCULATOR
Manufacturer
MD SCIENTIFIC LLC
Date Cleared
2006-06-14
(217 days)
Product Code
NDC
Regulation Number
868.1890Why did this record match?
Applicant Name (Manufacturer) :
MD SCIENTIFIC LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The EndoTool™ Drug Dose Calculator is a software support system designed for use by trained healthcare professionals to calculate any individual patient's optimal next dose for insulin administered intravenously to control blood glucose level for critically ill patients without inducing hypoglycemia (low blood glucose levels). EndoTool™ is for use with patients who are receiving a relative constant nutritional intake via intravenous fluids with dextrose, total parental nutrition or continuous gastro-intestinal feedings by any route of delivery.
Device Description
EndoTool™ Drug Dose Calculator is software that resides on a Microsoft/Intel platforms to calculate (see Section 9.2, page 20) the drug dose of insulin to control blood glucose levels for critically ill patients on continuous feeding (IV, TBN, or tube feeding).
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