Diagnostix Portable Set, 3.5v,OtoL/OphX


Product Overview

Diagnostix Portable Set, 3.5v,OtoL/OphX
Diagnostix™ - 5410A


Device Description

A collection of battery-powered devices intended to be used by a physician to perform an ophthalmic and/or otoscopic clinical examination on a patient. The devices are typically enclosed in a dedicated case and will typically include an ophthalmoscope and an otoscope, a dedicated interchangeable handle that contains the batteries which may be rechargeable and common to these examination devices, spare parts (e.g., extra ear specula, light bulbs) may include a line-powered charging station (e.g., desktop, wall-mounted) to house/charge these devices. This is a reusable device that may contain some disposable devices.


Environmental Conditions

  • Storage Environment Humidity - Percent (%) Relative Humidity
    • 95.00
    • 10.00
  • Storage Environment Temperature - Degrees Fahrenheit
    • 131.00
    • 14.00

  • Device Sizes

    No Data Available


    Device Sterilization

    Device Sterile: False

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    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


    Device Identifiers

    Device Id: 00634782577834

    Device Type: Package

    DeviceId Issuing Agency: GS1

    Contains DI Number: 00634782076467

    Package Quantity: 3

    Package Discontinue Date: N/A

    Package Status: In Commercial Distribution

    Package Type: Master Case


    Device Id: 00634782076467

    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


    GMDN ®. © GMDN Agency 2005-2024.
    Educational Resources
    Videos