AccessGUDID - DEVICE: Romet (00860009460539)

GUDID

Device Identifier (DI) Information

Brand Name: Romet
Version or Model: R700
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Fountain Head Marketing Inc.

Primary DI Number: 00860009460539
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 830442310 *Terms of Use

Device Description: Get up to date with the latest electronic larynx device, the R700! The R700 is the latest and modern electronic larynx model to hit the market. Being the most economical option out there, this artificial larynx is designed for the voice impaired adult providing countless benefits and modern improvements over other artificial larynx devices, including: Volume and pitch controls to customize the sound just the way you want it. Permanently installed Li-Ion battery saving you money on AA or AAA batteries. Gun metal electroplated Aluminum Barrel Installed Li-Ion battery offers a safer alternative to NiMH batteries. (NiMH depletes charge even when not in use) 30 hours of reliable speaking time. USB rechargeable. No batteries needed! EU adapter, USB charging cable, charging brick, and lanyard is included! Operating instructions, basic use, programming, battery information and more can be found in the Operating Instructions included with each box.

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: 6a2e1d8b-967c-4e23-882f-d215b0f601ff
Public Version Date: November 23, 2023
Public Version Number: 1
DI Record Publish Date: November 15, 2023