t:slim X2 Insulin Pump with Control-IQ Technology

t:slim X2 Insulin Pump with Control-IQ Technology - 1012869

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

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

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

Device Id: 00389152286914

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