PUMP MMT-722LNAS PRDGM 2.4 SK PR LN


Product Overview

PUMP MMT
PARADIGM® REAL-time - MMT-722LNAS


Device Description

A portable electronic device designed to provide continuous or intermittent subcutaneous delivery of insulin to a patient with diabetes mellitus; it does not include insulin dosage determining software. It may be badge-like, designed to adhere to skin or clothing (e.g., with a pressure-sensitive adhesive), or worn in a case attached to the belt or carried in a pocket. It includes a reservoir (e.g., a cartridge similar to a syringe), a pumping mechanism, and an infusion-rate controller.


Environmental Conditions

  • Storage Environment Temperature - Degrees Celsius
    • 55.00
    • -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: MDS

    Device Name: Sensor, Glucose, Invasive

    Device Class: 3

    Physical State: N/A

    Definition: The device is a glucose-monitoring device indicated for detecting trends and tracking patterns in adults (age 18 and older) with diabetes. The device is indicated for use as an adjunctive device to complement, not replace, information obtained from standard home glucose monitoring devices. The system aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments.

    Submission Type ID: 2

    Review Panel: CH

    Review Code: N/A

    Technical Method: N

    Gmp Exempt Flag: N/A

    Life Sustain Support Flag: N

    Unclassified Reason: N/A

    Implant Flag: N

    Target Area: N/A

    Regulation Number: N/A

    Third Party Flag: N

    Medical Specialty: N/A


    Code: OYC

    Device Name: Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor

    Device Class: 3

    Physical State: Must include product code MDS, sensor, invasive test system, or product code PQF, sensor, glucose, invasive, non-adjunctive.

    Definition: The insulin pump is intended to be used as a component of an invasive glucose device. The pump is designed to pump fluid (insulin) into a patient in a controlled manner as an aid in the mangement of diabetes mellitus in persons requiring insulin. It is intended to accept and display data from the glucose sensor.

    Submission Type ID: 2

    Review Panel: CH

    Review Code: N/A

    Technical Method: N

    Gmp Exempt Flag: The pump is designed to pump fluid (insulin) into a patient in a controlled manner as an aid in the mangement of diabetes mellitus in persons requiring insulin. It is intended to accept and display data from the glucose sensor

    Life Sustain Support Flag: N

    Unclassified Reason: N/A

    Implant Flag: N

    Target Area: see indications for use

    Regulation Number: N/A

    Third Party Flag: N

    Medical Specialty: N/A


    Device Identifiers

    Device Id: 00763000161088

    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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