Search Results
Found 1 results
510(k) Data Aggregation
K Number
K081388Device Name
GLUCOCARE INTENSIVE GLYCEMIC CONTROL SYSTEM
Manufacturer
Date Cleared
2008-08-21
(94 days)
Product Code
Regulation Number
868.1890Why did this record match?
Applicant Name (Manufacturer) :
PRONIA MEDICAL SYSTEM, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The GlucoCare IGC System is a software program indicated for the management of patient blood glucose levels in the hospital setting. The GlucoCare IGC System software, using an algorithm that is based on an established clinical protocol, calculates the dosage of intravenously administered insulin required to maintain the blood glucose level within a target range set by the protocol. No medical decisions are made by the GlucoCare IGC System software. The information provided by the software is intended to be used as a tool by qualified and trained medical personnel. The GlucoCare IGC System software is intended for use in patients over the age of 18 with no known insulin allergies. The device is not intended for use in patients with diabetic ketoacidosis.
Device Description
The GlucoCare IGC System is a software program that implements an insulin infusion protocol intended for the treatment of hyperglycemic adult patients in a healthcare facility. The software directs insulin infusion rates based on the patient's blood glucose level history and target blood glucose level. Audible and visual alerts remind the medical staff when it is time to take blood glucose readings or change insulin drip rates. The system provides a complete time/date/username-stamped history of all patient activity in text and graphical formats, both on-screen and in a printable form. The GlucoCare IGC System software resides on the GlucoCare application server. Local client computers interact with the GlucoCare IGC System software using HTTPS.
Ask a Question
Ask a specific question about this device
Page 1 of 1