FreeStyle Precision Neo Blood Glucose Test Strips


Product Overview

FreeStyle Precision Neo Blood Glucose Test Strips
FreeStyle Precision Neo - 71577


Device Description

A collection of devices including a portable, battery-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 glucose and ketones in a whole blood clinical specimen; it is designed 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. Measured glucose values are used to manage blood glucose levels, primarily by persons with diabetes mellitus.


Environmental Conditions

  • Storage Environment Temperature - Degrees Fahrenheit
    • 86.00
    • 39.00

  • Device Sizes

    No Data Available


    Device Sterilization

    Device Sterile: False

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    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


    Code: LFR

    Device Name: Glucose Dehydrogenase, Glucose

    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: Y

    Medical Specialty: CH


    Device Identifiers

    Device Id: 30093815715772

    Device Type: Package

    DeviceId Issuing Agency: GS1

    Contains DI Number: 00093815715771

    Package Quantity: 12

    Package Discontinue Date: N/A

    Package Status: In Commercial Distribution

    Package Type: Case


    Device Id: 00093815715771

    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


    Device Id: 57599-1577-1

    Device Type: Secondary

    DeviceId Issuing Agency: NDC/NHRIC

    Contains DI Number: N/A

    Package Quantity: N/A

    Package Discontinue Date: N/A

    Package Status: N/A

    Package Type: N/A


    Device Id: 10093815715778

    Device Type: Unit of Use

    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


    Device Id: 40093815715779

    Device Type: Package

    DeviceId Issuing Agency: GS1

    Contains DI Number: 00093815715771

    Package Quantity: 12

    Package Discontinue Date: N/A

    Package Status: In Commercial Distribution

    Package Type: Case


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