(PDM) mg/dL - DASH, English

(PDM) mg/dL
Omnipod DASH Starter Kit - PDM-USA1-DOO1-MG-USA1

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.

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

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

Code: LZG

Device Name: Pump, Infusion, Insulin

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: 880.5725

Third Party Flag: N

Medical Specialty: HO

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: 10385082000009

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

Device Id: 20385082000006

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 10385082000009

Package Quantity: 1

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: Starter Kit

Device Id: 30385081140014

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 20385082000006

Package Quantity: 1

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: Welcome Kit

Device Id: 10385082000542

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 10385082000009

Package Quantity: 1

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: Starter Kit