SPEAX Digital Communicator Subscription Package FGN009

GUDID B792FGN009

Voice amplification system

Primary Device ID	B792FGN009
NIH Device Record Key	ccf9dde3-8e48-42e1-876a-e610c015df1c
Commercial Distribution Status	In Commercial Distribution
Brand Name	SPEAX Digital Communicator Subscription Package
Version Model Number	FGN-009
Catalog Number	FGN009
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	B792FGN009 [Primary]

ILQ	System, Communication, Powered

Steralize Prior To Use	false
Device Is Sterile	false

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