PUMP MMT-1884 780G US MG A1.01 6.21U BC


Product Overview

PUMP MMT
MiniMed™ 780G - MMT-1884


Device Description

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.


Environmental Conditions

  • Storage Environment Humidity - Percent (%) Relative Humidity
    • 95.00
    • 5.00
  • Storage Environment Temperature - Degrees Fahrenheit
    • 122.00
    • -4.00
  • Storage Environment Temperature - Degrees Celsius
    • 50.00
    • -20.00

  • Device Sizes

    No Data Available


    Device Sterilization

    Device Sterile: False

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    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 Identifiers

    Device Id: 00763000758530

    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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