Romet

Primary DI
00860009460546
Brand
Romet
Company
Fountain Head Marketing Inc.
Model
R600
Device description
The R600 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:Permanently installed Li-Ion battery saving you money on AA or AAA batteries.Gun metal electroplated Aluminum BarrelInstalled 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!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. Please be sure to consult with your SLP for the most optimal experience.
Published
2023-11-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
ESELarynx, Artificial (Battery-Powered)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ESELarynx, Artificial (Battery-Powered)Ear, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860009460546PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860009460546008600094605468600094605460860009460546

GMDN Terms#

Term, Definition table
TermDefinition
Voice amplification systemAn 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity20 Percent (%) Relative Humidity80 Percent (%) Relative Humidity
Handling Environment Temperature15 Degrees Celsius32 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
830442310
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860009460508RometR1202023-11-15
00860009460515RometR2102023-11-15
00860009460522RometR3102023-11-15
00860009460539RometR7002023-11-15
00860009460591Blom-SingerEL 20002023-11-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10850057368014Blom-SingerEnt Solutions LLCESE2023-12-18
10850057368021Blom-SingerEnt Solutions LLCESE2023-12-18
10850057368038Blom-SingerEnt Solutions LLCESE2023-12-18
10850057368007Blom-SingerEnt Solutions LLCESE2023-12-18
20850057368011Blom-SingerEnt Solutions LLCESE2023-12-18
20850057368028Blom-SingerEnt Solutions LLCESE2023-12-18
20850057368035Blom-SingerEnt Solutions LLCESE2023-12-18
00860009460508RometFountain Head Marketing Inc.ESE2023-11-15
00860009460515RometFountain Head Marketing Inc.ESE2023-11-15
00860009460522RometFountain Head Marketing Inc.ESE2023-11-15
00860009460539RometFountain Head Marketing Inc.ESE2023-11-15
00860009460591Blom-SingerFountain Head Marketing Inc.ESE2023-11-15
07331791015571Provox TruTone PlusAtos Medical ABESE2022-07-08
07331791015823Provox SolaTone PlusAtos Medical ABESE2022-07-08
07331791015830Provox TruTone EmoteAtos Medical ABESE2022-07-08
04040823006502SERVOX digital XLServona GmbHESE2021-02-18
00813124010981TruTone Plus® ElectrolarynxGRIFFIN LABORATORIESESE2021-02-05
00813124010738TruTone Plus® ElectrolarynxGRIFFIN LABORATORIESESE2020-08-24
00813124010974TruTone Plus® ElectrolarynxGRIFFIN LABORATORIESESE2020-08-24
00813124010868TeliTalk™ ElectrolarynxGRIFFIN LABORATORIESESE2020-03-17
00813124010875TeliTalk™ ElectrolarynxGRIFFIN LABORATORIESESE2020-03-17
00813124010004TruTone® ElectrolarynxGRIFFIN LABORATORIESESE2019-10-23
00813124010035SolaTone® ElectrolarynxGRIFFIN LABORATORIESESE2019-10-23
00813124010097TruTone® ElectrolarynxGRIFFIN LABORATORIESESE2019-10-23
00813124010103SolaTone Plus™ ElectrolarynxGRIFFIN LABORATORIESESE2019-10-23
00813124010110SolaTone Lite® ElectrolarynxGRIFFIN LABORATORIESESE2019-10-23
00813124010127SolaTone Plus™ ElectrolarynxGRIFFIN LABORATORIESESE2019-10-23
00813124010134TruTone Plus® ElectrolarynxGRIFFIN LABORATORIESESE2019-10-23
00813124010141TruTone EMOTE® ElectrolarynxGRIFFIN LABORATORIESESE2019-10-23
00813124010158TruTone EMOTE® ElectrolarynxGRIFFIN LABORATORIESESE2019-10-23