FreeStyle Libre 2 Plus Sensor Not For Retail Sale

FreeStyle Libre 2 Plus Sensor Not For Retail Sale
FreeStyle Libre 2 Plus - 78749

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.

No Data Available

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

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 Id: 30357599836000

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 00357599836009

Package Quantity: 24

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: N/A

Device Id: 00357599836009

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: 57599-0836-00

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