FreeStyle Libre Pro Software


Product Overview

FreeStyle Libre Pro Software
FreeStyle Libre Pro - 75170


Device Description

An application software program, routines, and/or algorithms used as or in an information system to electronically receive, collect, store, manage, assist in analysis of, display, output, and distribute data, within or between healthcare facilities, to support the administrative and clinical activities associated with the provision and utilization of home healthcare services and facilities. It is typically supplied for installation into a dedicated home healthcare information system or existing mainframe or decentralized computers/networks.


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: 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 Identifiers

Device Id: 30093815751701

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 00093815751700

Package Quantity: 30

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: Case


Device Id: 00093815751700

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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