SPEAX Patch FGN002

GUDID B792FGN003

Voice amplification system

Primary Device ID	B792FGN003
NIH Device Record Key	373849ec-060f-466d-b4c9-858e9ea0b11f
Commercial Distribution Status	In Commercial Distribution
Brand Name	SPEAX Patch
Version Model Number	FGN-002
Catalog Number	FGN002
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	true
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 -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between -10 Degrees Celsius and 50 Degrees Celsius

Device Issuing Agency	Device ID
HIBCC	B792FGN002 [Primary]
HIBCC	B792FGN003 [Package] Contains: B792FGN002 Package: white cardboard box [10 Units] In Commercial Distribution
HIBCC	B792FGN012 [Package] Package: cardboard box [2 Units] In Commercial Distribution

ILQ	System, Communication, Powered

Steralize Prior To Use	false
Device Is Sterile	false

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