BILATERAL SENSOR


Product Overview

BILATERAL SENSOR
BIS - 186-0212


Device Description

A photoelectric device designed to be applied externally to the scalp/head of a patient for transcutaneous measurement [e.g., using near-infrared spectroscopy (NIRS)] of brain tissue blood oxygen saturation and/or venous oxygen saturation in the brain. It connects to a cerebral oximeter via a fibreoptic cable and typically consists of a single/dual adhesive sensing strip. This is a single-use device.


Environmental Conditions

  • Storage Environment Temperature - Degrees Fahrenheit
    • 85.00
    • 50.00

  • Device Sizes

    No Data Available


    Device Sterilization

    Device Sterile: False

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    Code: GXY

    Device Name: Electrode, Cutaneous

    Device Class: 2

    Physical State: N/A

    Definition: N/A

    Submission Type ID: 1

    Review Panel: NE

    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: 882.1320

    Third Party Flag: Y

    Medical Specialty: NE


    Device Identifiers

    Device Id: 10884521134478

    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: 90884521657850

    Device Type: Package

    DeviceId Issuing Agency: GS1

    Contains DI Number: 20884521134475

    Package Quantity: 9999

    Package Discontinue Date: N/A

    Package Status: In Commercial Distribution

    Package Type: PALLET


    Device Id: 30884521657858

    Device Type: Package

    DeviceId Issuing Agency: GS1

    Contains DI Number: 10884521134478

    Package Quantity: 10

    Package Discontinue Date: N/A

    Package Status: In Commercial Distribution

    Package Type: PACK_OR_INNER_PACK


    Device Id: 20884521134475

    Device Type: Package

    DeviceId Issuing Agency: GS1

    Contains DI Number: 30884521657858

    Package Quantity: 10

    Package Discontinue Date: N/A

    Package Status: In Commercial Distribution

    Package Type: CASE


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