AccessGUDID - DEVICE: Romet (00860009460508)

GUDID

Device Identifier (DI) Information

Brand Name: Romet
Version or Model: R120
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Fountain Head Marketing Inc.

Primary DI Number: 00860009460508
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 830442310 *Terms of Use

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

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
30076	Voice amplification system	An assembly of battery-powered, personal-worn, devices designed to amplify the loudness of the voice of a person with reduced vocal capacity (e.g., due to impairment of throat or chest muscles, partial paralysis of vocal cords, diminished lung capacity). It typically includes a dedicated microphone, an electronic amplifier, and a loudspeaker. Assemblies with special adaptors that are intended for use with an artificial larynx, a transoesophageal puncture tube, and/or other prostheses or implants are available. Some amplifiers are available as an integral part of an artificial larynx.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ESE	Larynx, Artificial (Battery-Powered)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

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

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 89b35b35-32f6-4167-86eb-cd9a019d0771
Public Version Date: November 23, 2023
Public Version Number: 1
DI Record Publish Date: November 15, 2023