REPL KIT MMT
Guardian™ Link - MMT-7763NA
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
- 100.00
- 10.00
- 55.00
- -25.00
Device Sizes
No Data Available
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
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 IdentifiersDevice Id: 00763000047665
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
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