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510(k) Data Aggregation
K Number
K061110Device Name
GLUCOMMANDER PLUS
Manufacturer
COLLABORATIVEMED, LLC
Date Cleared
2006-06-07
(48 days)
Product Code
NDC
Regulation Number
868.1890Why did this record match?
Applicant Name (Manufacturer) :
COLLABORATIVEMED, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Glucommander is intended to evaluate the current as well as cumulative patient blood glucose values, and, based on the aggregate of those measurements, whether one or many, calculate and recommend a dose of saline, glucose, and insulin to drive the blood glucose level, either up or down, towards a predetermined target range. Once that target blood glucose range has been reached, the system's function is to recommend dosing of insulin, glucose, and saline for the purpose of maintaining the patient's blood glucose level in that target range. The system is programmed to provide intravenous dosing of glucose, saline, and insulin; as well as subcutaneous dosing of glucose and insulin. The device is not intended for use with patients with known insulin allergies or patients under the age of 18.
The Glucommander's programmed logic is not a substitute for, but rather an assist to clinical reasoning. The measurements and calculations generated by the GBGDS are intended to be used by qualified and trained medical personnel in evaluating patient conditions in conjunction with clinical history, symptoms, and other diagnostic measurements, as well as the medical professional's clinical judgment. No medical decision should be based solely on the recommended guidance provided by this software program.
Device Description
The Glucommander is a simple, automated, computer-based software application that, based on frequent patient glucose measurement inputs, calculates and recommends titration of intravenous and subcutaneous insulin infusion rates and intravenous qlucose infusion and oral glucose consumption rates, calculated to medicate a patient's blood glucose level towards a specified target range. The Glucommander also provides alarms and warnings, as well as alerts for subsequent blood glucose testing and monitoring.
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