FreeStyle Libre Sensor Kit

FreeStyle Libre Sensor Kit
FreeStyle Libre - 71536

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: PZE

Device Name: Sensor, Glucose, Invasive, Non-Adjunctive, Factory-Calibrated, User-Initiated

Device Class: 3

Physical State: This device comprises a skin piercing sensor containing the glucose specific biological sensor, an algorithm that converts sensor signals into glucose values, a display device which provides glucose values to the user and a mechanism for transmitting data from the sensor to the display device.

Definition: A subcutaneous factory calibrated, non-adjunctive, invasive, passive monitoring glucose sensor is intended to determine glucose levels and the direction and rate of change of glucose levels in people with diabetes. Calibrated at the point of manufacture and does not require or accept any user-entered calibration. Monitors glucose levels passively and only provides information, including alarms and alerts, in response to a user initiated action. The device is indicated to replace information obtained from standard blood glucose monitoring devices to make diabetes-related treatment decisions and also provides historical glucose information, facilitating long-term therapy adjustments.

Submission Type ID: 2

Review Panel: CH

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: Signals from an invasive (skin piercing) glucose specific biological sensor are algorithmically converted to glucose values which are provided to the user.

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: Interstitial fluid.

Regulation Number: N/A

Third Party Flag: N

Medical Specialty: N/A

Device Id: 30357599000197

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 00357599000196

Package Quantity: 24

Package Discontinue Date: 12/3/2020 12:00:00 AM

Package Status: Not in Commercial Distribution

Package Type: Case

Device Id: 00357599000196

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: 57599-0000-19

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