SPEAX Digital Communicator FGN007

GUDID B792FGN007

Voice amplification system

Primary Device ID	B792FGN007
NIH Device Record Key	179fdb07-3211-4fac-9a66-1b4cdef60231
Commercial Distribution Status	In Commercial Distribution
Brand Name	SPEAX Digital Communicator
Version Model Number	FGN-007
Catalog Number	FGN007
Company DUNS	117116534
Company Name	ATAIA INC.
Device Count	1
DM Exempt	false
Pre-market Exempt	true
MRI Safety Status	MR Unsafe
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	true
Serial Number	false
Manufacturing Date	true
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Storage Environment Temperature	Between -20 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between -20 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between -20 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between -20 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between -20 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between -20 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between -20 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between -20 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between -20 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between -20 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between -20 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between -20 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between -20 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between -20 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between -20 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between -20 Degrees Celsius and 25 Degrees Celsius

Device Issuing Agency	Device ID
HIBCC	B792FGN007 [Primary]

ILQ	System, Communication, Powered

Steralize Prior To Use	false
Device Is Sterile	false

B792FGN010 - SPEAX Patch for Home Use	2022-02-03 Patch for use with the SPEAX Digital Communication System for Home Use
B792FGN011 - SPEAX Digital Communication System for Home Use	2022-02-03 SPEAX Digital Communication System for Home Use including Digital Communicator and Patches for Home Use
B792FGN009 - SPEAX Digital Communicator Subscription Package	2022-01-28 The Digital Communicator Subscription Package for the SPEAX Communication System, including 1 Digital Communicator and 20 Patche
B792FGN008 - SPEAX Digital Communicator Trial Package	2021-10-18 The Digital Communicator Trial Package for the SPEAX Communication System, including 1 Digital Communicator and 10 Patches.
B792FGN007 - SPEAX Digital Communicator	2021-07-13Digital Communicator for use with the SPEAX Communication System
B792FGN007 - SPEAX Digital Communicator	2021-07-13 Digital Communicator for use with the SPEAX Communication System
B792FGN001 - SPEAX Communicator	2020-03-17 Communicator for use with the SPEAX Communication System
B792FGN003 - SPEAX Patch	2020-03-17 Patch for use with the SPEAX Communication System
B792FGN004 - SPEAX Starter Package	2020-03-17 The Starter Package for the SPEAX Communication System, including 5 Communicators and 30 Patches