FreeStyle Libre 2 Plus Sensor


Product Overview

FreeStyle Libre 2 Plus Sensor
FreeStyle Libre 2 Plus - 78747


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 Atmospheric Pressure - KiloPascal
    • 106.00
    • 70.00
  • 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: QBJ

    Device Name: Integrated Continuous Glucose Monitoring System, Factory Calibrated

    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 (iCGM) is intended to automatically measure glucose in bodily fluids continuously or frequently for a specified period of time. iCGM systems are designed to reliably and securely transmit glucose measurement data to digitally connected devices, including automated insulin dosing systems, and are intended to be used alone or in conjunction with these digitally connected medical devices for the purpose of managing a disease or condition related to glycemic control.

    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


    Code: NBW

    Device Name: System, Test, Blood Glucose, Over The Counter

    Device Class: 2

    Physical State: N/A

    Definition: N/A

    Submission Type ID: 1

    Review Panel: CH

    Review Code: N/A

    Technical Method: N

    Gmp Exempt Flag: N/A

    Life Sustain Support Flag: N

    Unclassified Reason: N/A

    Implant Flag: N

    Target Area: N/A

    Regulation Number: 862.1345

    Third Party Flag: N

    Medical Specialty: CH


    Device Identifiers

    Device Id: 30357599835003

    Device Type: Package

    DeviceId Issuing Agency: GS1

    Contains DI Number: 00357599835002

    Package Quantity: 24

    Package Discontinue Date: N/A

    Package Status: In Commercial Distribution

    Package Type: N/A


    Device Id: 00357599835002

    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: 57599-0835-00

    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


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