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510(k) Data Aggregation
K Number
K031373Device Name
IXL DIABETES MANAGEMENT SYSTEM
Manufacturer
INSULET CORP.
Date Cleared
2003-12-19
(233 days)
Product Code
LZG
Regulation Number
880.5725Why did this record match?
Applicant Name (Manufacturer) :
INSULET CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For the continuous, subcutaneous delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin.
Device Description
The iXL Diabetes Management System has two (2) components: a Remote Controller, and an insulin infusion Pump, and two accessories; a fill syringe, and fill needle.
The Remote Controller is a hand held, battery-operated device, with 9 functional buttons and an electro-luminescent (EL) backlit liquid crystal display (LCD). The device provides audio alarms, alerts and reminders.
The Pump is activated and controlled exclusively through the use of the Remote Controller. The Pump and Remote Controller interact wirelessly using secure, radio frequency (RF).
The Pump is a microprocessor controlled device. The Pump is worn directly on the body in the same manner and general locations as a conventional insulin infusion set. The Pump will leliver insulin based on the users custom programmed basal rate and bolus does for up to 72 houvs. The Pump provides audio alarms, alerts and reminders.
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