Adstation Oto-Xen/Coax+Oph-Xen, 429, ,9003W/Spec Disp, WB


Product Overview

Adstation Oto
Diagnostix™ - 56102X-348W


Device Description

A hand-held, electrically-powered instrument designed to estimate the temperature of a site on the skin (e.g., axilla, forehead) by measurement of body infrared emissions at this particular point. It provides a method to determine temperature patterns or variations on the surface of the skin (e.g., due to differences in perfusion). This device may be used in the home. This is a reusable device.


Environmental Conditions

  • Storage Environment Humidity - Percent (%) Relative Humidity
    • 85.00
    • 10.00
  • Storage Environment Temperature - Degrees Fahrenheit
    • 122.00
    • 23.00

  • Device Sizes

    No Data Available


    Device Sterilization

    Device Sterile: False

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    Code: FLL

    Device Name: Thermometer, Electronic, Clinical

    Device Class: 2

    Physical State: N/A

    Definition: N/A

    Submission Type ID: 1

    Review Panel: HO

    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: 880.2910

    Third Party Flag: Y

    Medical Specialty: HO


    Code: HLJ

    Device Name: Ophthalmoscope, Battery-Powered

    Device Class: 2

    Physical State: N/A

    Definition: N/A

    Submission Type ID: 4

    Review Panel: OP

    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: 886.1570

    Third Party Flag: N

    Medical Specialty: OP


    Code: ERA

    Device Name: Otoscope

    Device Class: 1

    Physical State: N/A

    Definition: N/A

    Submission Type ID: 4

    Review Panel: EN

    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: 874.4770

    Third Party Flag: N

    Medical Specialty: EN


    Code: DXN

    Device Name: System, Measurement, Blood-Pressure, Non-Invasive

    Device Class: 2

    Physical State: N/A

    Definition: N/A

    Submission Type ID: 1

    Review Panel: CV

    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: 870.1130

    Third Party Flag: Y

    Medical Specialty: CV


    Device Identifiers

    Device Id: 00634782096694

    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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