Romet

GUDID 00860009460508

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.

Fountain Head Marketing Inc.

Voice amplification system

• Primary Device ID: 00860009460508
• NIH Device Record Key: 89b35b35-32f6-4167-86eb-cd9a019d0771
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Romet
• Version Model Number: R120
• Company DUNS: 830442310
• Company Name: Fountain Head Marketing Inc.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: true
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 32 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 32 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 32 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 32 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 32 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 32 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 32 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 32 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 32 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 32 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 32 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 32 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 32 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 32 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 32 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 32 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860009460508 [Primary]

FDA Product Code

• ESE: Larynx, Artificial (Battery-Powered)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-11-23
• Device Publish Date: 2023-11-15

On-Brand Devices [Romet]

• 00860009460546: The R600 is the latest and modern electronic larynx model to hit the market. Being the most econ
• 00860009460539: Get up to date with the latest electronic larynx device, the R700! The R700 is the latest and mo
• 00860009460522: After undergoing surgery for partial or total laryngectomy due to throat cancer or accidental da
• 00860009460515: After undergoing surgery for partial or total laryngectomy due to throat cancer or accidental da
• 00860009460508: Experience the power of communication with the Romet R120 Electronic Larynx, a cutting-edge devi