BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Romet

    DI: 00860009460508 · Model: R120 · Fountain Head Marketing Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Romet
    Primary DI
    00860009460508
    Version / Model
    R120
    Company Name
    Fountain Head Marketing Inc.
    Labeler DUNS
    830442310
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-11-15
    Public Version
    1
    Public Version Date
    2023-11-23
    Public Version Status
    New
    Public Device Record Key
    89b35b35-32f6-4167-86eb-cd9a019d0771

    Device Description

    Experience the power of communication with the Romet R120 Electronic Larynx, a cutting-edge device designed to empower laryngectomees and provide a seamless transition to vocal expression. With its exceptional features and reliable performance, this device is a must-have for anyone seeking a dependable electronic larynx unit. Effortless Control: The Romet R120 is equipped with a convenient on/off switch, providing easy functionality without overwhelming you with unnecessary volume or pitch controls. With simplicity in mind, this device allows you to focus on what matters most—expressing yourself and connecting with others. Economical and Versatile: The Romet R120 is an economical choice that can be used as your primary electronic larynx or as a reliable backup device. We understand the importance of having a dependable solution at hand, and this device is designed to seamlessly integrate into your daily life. Uninterrupted Communication: We care about your uninterrupted communication experience. That's why the Romet R120 includes two rechargeable 9V lithium batteries, ensuring that you always have a reliable power source available. Say goodbye to battery anxiety and hello to consistent communication. Empowering Laryngectomees: Developed with the needs of laryngectomees in mind, the Romet R120 caters to the keywords and phrases that matter most to individuals seeking a voice restoration device. From "electronic larynx" to "speech aid" and "artificial larynx," this product is optimized to ensure that it reaches those who need it most. Trusted by Professionals: Speech language pathologists recognize the Romet R120 as a reliable and effective tool for laryngectomees. With its exceptional performance and user-friendly design, it has become a sought-after choice among professionals and individuals alike. Restoring speech to over 20 countries: The R120 has helped laryngectomees speak in over 20 countries! Unlock the power of your voice with the Romet R120 Electronic Larynx. Regain your ability to communicate effortlessly, connect with loved ones, and thrive in social settings.

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    No
    Kit
    No
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    No
    MRI Safety
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    Yes
    PM Exempt
    Yes
    Has Serial Number
    Yes
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    Yes
    Has Expiration Date
    No
    Has Donation ID
    Yes

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    ESE Larynx, Artificial (Battery-Powered)

    GMDN Terms

    Code Name
    30076 Voice amplification system

    Identifiers

    Type ID
    Primary 00860009460508

    Storage Conditions

    Type
    Handling Environment Humidity
    Temperature Range
    20 – 80 Percent (%) Relative Humidity
    Type
    Handling Environment Temperature
    Temperature Range
    15 – 32 Degrees Celsius