FreeStyle Libre 3 Sensor Kit US

Product Overview

FreeStyle Libre 3 Sensor Kit US
FreeStyle Libre 3 - 72081

Device Description

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.

Environmental Conditions

  • Storage Environment Humidity - Percent (%) Relative Humidity
    • 90.00
    • 10.00
  • Storage Environment Temperature - Degrees Fahrenheit
    • 82.00
    • 36.00

  • Device Sizes

    No Data Available

    Device Sterilization

    Device Sterile: True

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available

    Product Codes

    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 Identifiers

    Device Id: 30357599818006

    Device Type: Package

    DeviceId Issuing Agency: GS1

    Contains DI Number: 00357599818005

    Package Quantity: 1

    Package Discontinue Date: N/A

    Package Status: In Commercial Distribution

    Package Type: Case

    Device Id: 00357599818005

    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

    Device Id: 57599-0818-00

    Device Type: Secondary

    DeviceId Issuing Agency: NDC/NHRIC

    Contains DI Number: N/A

    Package Quantity: N/A

    Package Discontinue Date: N/A

    Package Status: N/A

    Package Type: N/A

    Educational Resources