t:connect Mobile Application (iOS)

t:connect Mobile Application (iOS)
t:connect Mobile Application (iOS) - 1004128

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).

No Data Available

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: PJT

Device Name: Continuous Glucose Monitor Secondary Display

Device Class: 2

Physical State: Typically a software device installed on a third-party mobile device.

Definition: The purpose of the continuous glucose monitor secondary display is to notify another person, the follower, of the patient's continuous glucose monitoring system sensor glucose information in real time. The secondary display is intended for providing secondary notification of a continuous glucose monitoring system and does not replace primary real time continuous glucose 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 a continuous glucose monitor.

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: 00850006613274

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