SFTWR MMT-6102 AHCL APP 1.3.3 IOS

SFTWR MMT
MiniMed™ Mobile - MMT-6102

An application software program designed for the continual collection and aggregation of a patient's self-care data to promote communication between patient and healthcare provider, to facilitate a patient's self-care by using rules defined during use of the application, and/or to facilitate population monitoring. It is typically used to capture clinical (e.g., blood pressure, weight, and blood glucose), nutritional, and/or exercise information in the home, which may include medication administration information captured from enabled injection devices and data from wearable devices, providing care plan, journal, medication advice, and/or messaging functionalities.

No Data Available

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

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 Id: 00763000416676

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