FreeStyle CoPilot Health Management System

FreeStyle CoPilot Health Management System
FreeStyle CoPilot - 71137

A collection of devices including a portable, electrically-powered, semi-automated or automated instrument (self-testing meter), reagents, test strips and/or other associated materials and accessories (e.g., control solutions, lancets) intended to be used together for the quantitative measurement of multiple clinical chemistry analytes in a clinical specimen. Analytes detected may include electrolytes, specific proteins, clinical chemistry substrates (e.g., lipid profile), liver and/or cardiac function test analytes, and/or enzymes. It is intended to be used for self-testing by a layperson in the home, and some types may in addition be used at the point-of-care.

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No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: NBW

Device Name: System, Test, Blood Glucose, Over The Counter

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 1

Review Panel: CH

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: N/A

Regulation Number: 862.1345

Third Party Flag: N

Medical Specialty: CH

Device Id: 30357599000173

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 00357599000172

Package Quantity: 30

Package Discontinue Date: 5/31/2024 12:00:00 AM

Package Status: Not in Commercial Distribution

Package Type: Case

Device Id: 00357599000172

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