FreeSyle Libre Software CD

FreeSyle Libre Software CD
FreeStyle Libre - 71527

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: PHV

Device Name: Continuous Glucose Monitor Retrospective Data Analysis Software

Device Class: 1

Physical State: Software

Definition: Continuous glucose monitor retrospective data analysis software is intended to analyze and correlate retrospective data from a continuous glucose monitoring device.

Submission Type ID: 4

Review Panel: CH

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: data analysis system

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: Not Applicable

Regulation Number: 862.2120

Third Party Flag: N

Medical Specialty: CH

Device Id: 30357599000470

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 00357599000479

Package Quantity: 8

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: Case

Device Id: 00357599000479

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