NovaChat

GUDID 00858526006996

NC8.5 Keyguard 84 location

PRENTKE ROMICH COMPANY

Voice synthesizer/digitizer Voice synthesizer/digitizer Voice synthesizer/digitizer Voice synthesizer/digitizer Voice synthesizer/digitizer Voice synthesizer/digitizer Voice synthesizer/digitizer Voice synthesizer/digitizer Voice synthesizer/digitizer Voice synthesizer/digitizer Voice synthesizer/digitizer Voice synthesizer/digitizer Voice synthesizer/digitizer Voice synthesizer/digitizer

Primary Device ID	00858526006996
NIH Device Record Key	c2ed1841-db0a-41d8-b947-013256bebf3e
Commercial Distribution Status	In Commercial Distribution
Brand Name	NovaChat
Version Model Number	20062-84
Company DUNS	080143399
Company Name	PRENTKE ROMICH COMPANY
Device Count	1
DM Exempt	false
Pre-market Exempt	true
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	false
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	true

Device Dimensions

Length	7.94 Inch
Width	4.42 Inch
Height	0.18 Inch
Length	7.94 Inch
Width	4.42 Inch
Height	0.18 Inch
Length	7.94 Inch
Width	4.42 Inch
Height	0.18 Inch
Length	7.94 Inch
Width	4.42 Inch
Height	0.18 Inch
Length	7.94 Inch
Width	4.42 Inch
Height	0.18 Inch
Length	7.94 Inch
Width	4.42 Inch
Height	0.18 Inch
Length	7.94 Inch
Width	4.42 Inch
Height	0.18 Inch
Length	7.94 Inch
Width	4.42 Inch
Height	0.18 Inch
Length	7.94 Inch
Width	4.42 Inch
Height	0.18 Inch
Length	7.94 Inch
Width	4.42 Inch
Height	0.18 Inch
Length	7.94 Inch
Width	4.42 Inch
Height	0.18 Inch
Length	7.94 Inch
Width	4.42 Inch
Height	0.18 Inch
Length	7.94 Inch
Width	4.42 Inch
Height	0.18 Inch
Length	7.94 Inch
Width	4.42 Inch
Height	0.18 Inch

Device Identifiers

Device Issuing Agency	Device ID
GS1	00858526006996 [Primary]

FDA Product Code

ILQ	System, Communication, Powered

Sterilization

Steralize Prior To Use	false
Device Is Sterile	false

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2023-10-19
Device Publish Date	2023-10-11

On-Brand Devices [NovaChat]

00816486021343	NovaChat 10.7 TouchGuide 60 location
00816486021336	NovaChat 10.7 TouchGuide 42 location
00816486021329	NovaChat 10.7 TouchGuide 25 Location
00816486021312	NovaChat 10.7 Set of multiple TouchGuides
00816486021305	NovaChat 10.7 Keyguard 84 location
00816486021299	NovaChat 10.7 Keyguard 60 location
00816486021282	NovaChat 10.7 Keyguard 42 location
00816486021275	NovaChat 10.7 Keyguard 25 location
00816486021268	NovaChat 10.7 Keyguard 20 location
00816486021251	NovaChat 10.7 Keyguard 15 location
00816486021244	NovaChat 10.7 Set of multiple Keyguards
00816486021220	Nova Chat 10.7 is a speech generating device with a 10 inch screen.
00816486021381	NovaChat 8.5 is a speech generating device with an 8 inch screen
00858526006996	NC8.5 Keyguard 84 location
00858526006989	NC8.5 Keyguard 60 location
00858526006972	NC8.5 Keyguard 42 location
00858526006965	NC8.5 Keyguard 25 location
00858526006958	NC8.5 Keyguard 20 location
00858526006941	NC8.5 Keyguard 15 location
00816486021497	NC8.5 TouchGuide 60 Location
00816486021480	NC8.5 TouchGuide 25 Location
00816486021473	NC8.5 TouchGuide 42 location