KIT MMT-1760KM 670G V4.11 MG

KIT MMT
MiniMed® 670G - MMT-1760KM

A portable electronic device designed to provide continuous or intermittent subcutaneous delivery of insulin to a patient with diabetes mellitus, incorporating software to receive glucose status data from a monitor/transmitter and to determine the delivery of insulin based on a continuous scalar algorithm. It may be badge-like, designed to adhere to skin or clothing or worn in a case attached to the belt or carried in a pocket and includes a reservoir, a pumping mechanism, and an infusion-rate controller. It may also allow additional manual administration/infusion and functionality to send data to a remote reporting system.

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: OZP

Device Name: Automated Insulin Dosing Device System, Single Hormonal Control

Device Class: 3

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

Definition: An insulin-only automated insulin dosing system that achieves a target glucose level by automatically increasing or reducing insulin infusion from an insulin pump. Insulin adjustments are 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 and increases 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 management software

Regulation Number: N/A

Third Party Flag: N

Medical Specialty: N/A

Device Id: 00763000367077

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