Home GUDID B792FGN003 SPEAX Patch
Primary DI B792FGN003
Brand SPEAX Patch
Company ATAIA INC.
Model FGN-002
Catalog number FGN002
Device description Patch for use with the SPEAX Communication System
Published 2020-03-09
Public version status New
Distribution status In Commercial Distribution
MRI safety MR Unsafe
Rx true
OTC false
Sterile false
Single use true Product Codes# Code, Name table Code Name ILQ System, Communication, Powered
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class ILQ System, Communication, Powered Physical Medicine 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status B792FGN003 Package HIBCC 10 In Commercial Distribution B792FGN012 Package HIBCC 2 In Commercial Distribution B792FGN002 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition 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.
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Temperature -10 Degrees Celsius 50 Degrees Celsius
Regulatory Flags# DUNS number 117116534 Device count 1 DM exempt false Premarket exempt true HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label true Expiration date on label false Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published B792FGN002 SPEAX Patch FGN-002 FGN002 2020-03-09 B792FGN010 SPEAX Patch for Home Use FGN-010 FGN010 2022-01-26 B792FGN011 SPEAX Digital Communication System for Home Use FGN-011 FGN011 2022-01-26 B792FGN009 SPEAX Digital Communicator Subscription Package FGN-009 FGN009 2022-01-20 B792FGN008 SPEAX Digital Communicator Trial Package FGN-008 FGN008 2021-10-08 B792FGN007 SPEAX Digital Communicator FGN-007 FGN007 2021-07-05 B792FGN001 SPEAX Communicator FGN-001 FGN001 2020-03-09 B792FGN006 SPEAX Trial Package FGN-006 FGN006 2020-03-09 B792FGN004 SPEAX Starter Package FGN-004 FGN004 2020-03-09
Other Devices Sharing Product Codes# 
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