Romet

GUDID 00860009460539

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.

Fountain Head Marketing Inc.

Voice amplification system

• Primary Device ID: 00860009460539
• NIH Device Record Key: 6a2e1d8b-967c-4e23-882f-d215b0f601ff
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Romet
• Version Model Number: R700
• 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	00860009460539 [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