Omnipod 5 Starter Kit mg/dl

Omnipod 5 Starter Kit mg/dl
Omnipod 5 Starter Kit - SKT-M001-G-X9

An assembly of portable devices intended to simultaneously continuously monitor interstitial glucose levels and subcutaneously infuse insulin in patients with diabetes. Sometimes referred to as a closed loop artificial pancreas, it consists of a percutaneous blood glucose monitoring system (CGM), an ambulatory insulin infusion pump, and software on a dedicated handset or transmitter capable of telemetric communication with the other components. The software contains an algorithm to allow continuous communication between the two devices, and may enable the manual input of data with respect to meals and physical activity.

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

Code: QJI

Device Name: Interoperable Automated Glycemic Controller

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 is a device intended to automatically calculate drug doses based on inputs such as glucose and other relevant physiological parameters, and to command the delivery of such drug doses from a connected infusion pump. Interoperable automated glycemic controllers are designed to reliably and securely communicate with digitally connected devices to allow drug delivery commands to be sent, received, executed, and confirmed. Interoperable automated glycemic controllers 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 a integrated continuous glucose monitor to measure glucose levels and increases or reduces insulin infusion from an alternate controller enabled insulin pump.

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: SASO

Regulation Number: 862.1356

Third Party Flag: N

Medical Specialty: CH

Code: QRX

Device Name: Continuous Glucose Monitor Informed Insulin Dose Calculator

Device Class: 2

Physical State: Software as a medical device.

Definition: A continuous glucose monitor (CGM)-informed insulin dose calculator is a software device that calculates suggested insulin doses based on CGM values and/or other relevant information.

Submission Type ID: 1

Review Panel: CH

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: Software algorithm.

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: Software.

Regulation Number: 862.1358

Third Party Flag: N

Medical Specialty: CH

Code: KGX

Device Name: Tape And Bandage, Adhesive

Device Class: 1

Physical State: N/A

Definition: N/A

Submission Type ID: 4

Review Panel: SU

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: 880.5240

Third Party Flag: N

Medical Specialty: HO

Device Id: 10385083000503

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