Mobile App utilized in the PDM (Personal Device Manager) for Dash Insulin pump secondary display. PDM Device 18239; app 41252


Product Overview

Mobile App utilized in the PDM (Personal Device Manager) for Dash Insulin pump secondary display. PDM Device 18239; app 41252
Omnipod (Dash) Display App. - 1.3.1


Device Description

A software application intended to allow a patient or caregiver to remotely extract and view data from an electronic ambulatory insulin infusion pump to support treatment monitoring; it is not intended to control pump settings. It is intended to be used on a non-medical computerized device (e.g., smartphone).


Environmental Conditions

No Data Available


Device Sizes

No Data Available


Device Sterilization

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available


Product Codes

Code: PKU

Device Name: Insulin Pump Secondary Display

Device Class: 2

Physical State: Typically a software device installed on a third-party mobile device, or implemented in a web-based platform.

Definition: The purpose of the insulin pump secondary display is to notify another person of the patient's insulin pump usage information in real time. The secondary display is intended for providing secondary notification of insulin pump usage and does not replace primary real time insulin pump monitoring or standard home blood glucose monitoring.

Submission Type ID: 4

Review Panel: CH

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: Receives and displays real-time patient data from an insulin pump.

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: n/a

Regulation Number: 862.1350

Third Party Flag: N

Medical Specialty: CH


Device Identifiers

Device Id: 10385081120265

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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