FreeStyle Libre 3 iOS App US

FreeStyle Libre 3 iOS App US
FreeStyle Libre 3 App - 72077-01

An assembly of electrically-powered, portable devices intended to continuously monitor interstitial-fluid glucose concentrations in a patient with diabetes mellitus, using an invasive electrochemical technique. It consists of an electrochemical, percutaneously-inserted electrode that physically connects to a cable or transmitter which communicates with a monitor or receiver (not included) that captures, stores, and converts the sensor signals to glucose concentrations for display. The system may be used in the home and clinical settings, and aids in the detection of episodes of hyperglycaemia and hypoglycaemia, facilitating acute/long-term therapy adjustments.

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Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: QLG

Device Name: Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems

Device Class: 2

Physical State: Glucose sensor, a transmitter, and a primary receiver. The device contains software to calculate glucose values.

Definition: An integrated continuous glucose monitoring system for replacement of finger stick blood glucose testing for diabetes treatment decisions in persons with diabetes, unless otherwise indicated. The system automatically measures glucose in bodily fluids continuously or frequently for a specified period of time. The system is also designed to reliably and securely transmit glucose measurement data to digitally connected devices and are intended to be used alone or in conjunction with these digitally connected devices where the user manually controls actions for therapy decisions. The system is not intended to be used with automated insulin dosing (AID) systems.

Submission Type ID: 1

Review Panel: CH

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: A transcutaneous glucose sensor which is factory calibrated. The sensor is inserted at home by the end user and is used in conjunction with the associated transmitter and receiver to monitor glucose levels for the management of diabetes.

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: Diagnostics

Regulation Number: 862.1355

Third Party Flag: N

Medical Specialty: CH

Device Id: 00357599817008

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A