t:slim X2 Insulin Pump with Control-IQ, 7.6.x, Refurbished Replacement


Product Overview

t:slim X2 Insulin Pump with Control
t:slim X2 Insulin Pump with Control-IQ - 1009643


Device Description

An assembly of battery-powered portable devices designed to deliver insulin and to measure blood glucose as an aid in the management of diabetes mellitus for a patient requiring insulin. It consists of a portable electronic insulin pump that provides continuous subcutaneous delivery of insulin at set and variable rates, and a wireless microprocessor remote controller that interfaces with the pump to control pump functions and receive pump status information. The controller also incorporates a blood glucose meter and built-in test strip port for the quantitative measurement of glucose in fresh capillary blood.


Environmental Conditions

  • Storage Environment Temperature - Degrees Fahrenheit
    • 140.00
    • -4.00

  • Device Sizes

    No Data Available


    Device Sterilization

    Device Sterile: False

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    Code: QFG

    Device Name: Alternate Controller Enabled Insulin Infusion Pump

    Device Class: 2

    Physical State: This device comprises an ambulatory insulin infusion pump to be worn on the body, including insulin reservoir and tubing components intended to connect to an insulin infusion set. This device is also comprised of software which is capable of interfacing with other digital devices.

    Definition: An alternate controller enabled insulin infusion pump (ACE insulin pump) is a device intended for the infusion of insulin into a patient. The ACE insulin pump may include basal and bolus drug delivery at set or variable rates. ACE insulin pumps are designed to reliably and securely communicate with external devices, such as automated insulin dosing systems, to allow insulin delivery commands to be received, executed, and confirmed. ACE insulin pumps are intended to be used both alone and in conjunction with digitally connected medical devices for the purpose of insulin delivery.

    Submission Type ID: 1

    Review Panel: CH

    Review Code: N/A

    Technical Method: N

    Gmp Exempt Flag: Pump software controls an electric motor which is designed to pump fluid (insulin) into a patient in a controlled manner. That software is designed to communicate wirelessly with other digital devices and be capable of interfacing with digitally connected devices.

    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 can work with other devices - Continuous glucose monitoring system, sensor, self monitoring blood glucose device, data management software.

    Regulation Number: 880.5730

    Third Party Flag: N

    Medical Specialty: CH


    Code: QJS

    Device Name: Interoperable Automated Glycemic Controller, Insulin Suspend

    Device Class: 2

    Physical State: This is a software device used to control a compatible insulin pump based on inputs from compatible glucose monitor.

    Definition: An interoperable automated glycemic controller, insulin suspend, is a device that temporarily suspend and resumes insulin infusion from a connected infusion pump based on specified thresholds and input glucose levels. Interoperable automated glycemic controllers, insulin suspend, are designed to reliably and securely communicate with digitally connected devices to allow insulin delivery suspension and resumption commands to be sent, received, executed, and confirmed. Interoperable automated glycemic controllers, insulin suspend, are intended to be used in conjunction with digitally connected devices for the purpose of maintaining glycemic control.

    Submission Type ID: 1

    Review Panel: CH

    Review Code: N/A

    Technical Method: N

    Gmp Exempt Flag: Works interoperably with an integrated continuous glucose monitor to measure glucose levels and suspend or resume insulin delivery from an alternate controller enabled insulin pump.

    Life Sustain Support Flag: N

    Unclassified Reason: N/A

    Implant Flag: N

    Target Area: Standalone software

    Regulation Number: 862.1356

    Third Party Flag: N

    Medical Specialty: CH


    Code: NDC

    Device Name: Calculator, Drug Dose

    Device Class: 2

    Physical State: N/A

    Definition: N/A

    Submission Type ID: 1

    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: 868.1890

    Third Party Flag: N

    Medical Specialty: AN


    Device Identifiers

    Device Id: 00389152000107

    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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