SENSOR MMT-7040B GUARDIAN4 1PK US IO

SENSOR MMT
Guardian™ 4 Sensor - MMT-7040B

A small, electronic device with micro-needle(s) intended to be inserted percutaneously into interstitial tissue to continuously measure and record interstitial fluid glucose concentrations, typically for detecting trends and tracking patterns in patients with diabetes mellitus. It is typically a thin, flexible, needle electrode that uses electrochemical means to convert glucose levels into an electrical signal. It typically has an adhesive covering that holds it to the skin surface, and transmits the signal via a cable or transmitter. This is a single-patient device intended be used for a period before being discarded.

No Data Available

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: SFI

Device Name: Sensor, Glucose, Invasive, Component Of Automated Insulin Delivery System

Device Class: 3

Physical State: This device comprises a glucose specific biological sensor, an algorithm that converts sensor signals into glucose values, and a mechanism for transmitting data from the sensor to specific connected devices.

Definition: The device is intended to measure glucose in interstitial fluid. It is intended to provide those measurements as inputs to appropriately qualified digitally connected devices, including automated insulin dosing systems, as determined by FDA.

Submission Type ID: 2

Review Panel: CH

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: Signals from a glucose specific biological sensor are algorithmically converted to glucose values which are transmitted to specific connected devices.

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: Diagnostics

Regulation Number: N/A

Third Party Flag: N

Medical Specialty: N/A

Device Id: 00763000413477

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