SENSOR MMT-7008B ENLITE PLUS 2L 1CL PR

SENSOR MMT
Enlite ® - MMT-7008B

An electrical conductor 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: OZO

Device Name: Automated Insulin Dosing , Threshold Suspend

Device Class: 3

Physical State: May include: Continuous glucose monitoring system, sensor, self monitoring blood glucose device, infusion pump, data management software

Definition: An automated insulin dosing system that temporarily suspends or reduces insulin infusion from an insulin pump based upon specified thresholds of measured glucose levels.

Submission Type ID: 2

Review Panel: CH

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: Uses a glucose monitoring system to measure glucose levels in interstitial fluid or blood and suspends or reduces insulin infusion from an insulin pump

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: Not meant to act on a specific part of the body but works with other devices - Continuous glucose monitoring system, sensor, self monitoring blood glucose device, data managment software

Regulation Number: N/A

Third Party Flag: N

Medical Specialty: N/A

Device Id: 00643169786738

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