NovaChat F19015-50

GUDID 00816486021381

NovaChat 8.5 is a speech generating device with an 8 inch screen

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

• Primary Device ID: 00816486021381
• NIH Device Record Key: f74651af-6d34-45d3-a5df-8974d8d80966
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NovaChat
• Version Model Number: NC8.5
• Catalog Number: F19015-50
• 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: true
• 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

Customer Support Contacts

• Phone: 800-262-1984
• Email: info@prentrom.com
• Phone: 800-262-1984
• Email: info@prentrom.com
• Phone: 800-262-1984
• Email: info@prentrom.com
• Phone: 800-262-1984
• Email: info@prentrom.com
• Phone: 800-262-1984
• Email: info@prentrom.com
• Phone: 800-262-1984
• Email: info@prentrom.com
• Phone: 800-262-1984
• Email: info@prentrom.com
• Phone: 800-262-1984
• Email: info@prentrom.com
• Phone: 800-262-1984
• Email: info@prentrom.com
• Phone: 800-262-1984
• Email: info@prentrom.com
• Phone: 800-262-1984
• Email: info@prentrom.com
• Phone: 800-262-1984
• Email: info@prentrom.com
• Phone: 800-262-1984
• Email: info@prentrom.com
• Phone: 800-262-1984
• Email: info@prentrom.com
• Phone: 800-262-1984
• Email: info@prentrom.com
• Phone: 800-262-1984
• Email: info@prentrom.com
• Phone: 800-262-1984
• Email: info@prentrom.com

Device Dimensions

• Weight: 2.1 Pound
• Length: 9.6 Inch
• Width: 7.3 Inch
• Height: 2 Inch
• Weight: 2.1 Pound
• Length: 9.6 Inch
• Width: 7.3 Inch
• Height: 2 Inch
• Weight: 2.1 Pound
• Length: 9.6 Inch
• Width: 7.3 Inch
• Height: 2 Inch
• Weight: 2.1 Pound
• Length: 9.6 Inch
• Width: 7.3 Inch
• Height: 2 Inch
• Weight: 2.1 Pound
• Length: 9.6 Inch
• Width: 7.3 Inch
• Height: 2 Inch
• Weight: 2.1 Pound
• Length: 9.6 Inch
• Width: 7.3 Inch
• Height: 2 Inch
• Weight: 2.1 Pound
• Length: 9.6 Inch
• Width: 7.3 Inch
• Height: 2 Inch
• Weight: 2.1 Pound
• Length: 9.6 Inch
• Width: 7.3 Inch
• Height: 2 Inch
• Weight: 2.1 Pound
• Length: 9.6 Inch
• Width: 7.3 Inch
• Height: 2 Inch
• Weight: 2.1 Pound
• Length: 9.6 Inch
• Width: 7.3 Inch
• Height: 2 Inch
• Weight: 2.1 Pound
• Length: 9.6 Inch
• Width: 7.3 Inch
• Height: 2 Inch
• Weight: 2.1 Pound
• Length: 9.6 Inch
• Width: 7.3 Inch
• Height: 2 Inch
• Weight: 2.1 Pound
• Length: 9.6 Inch
• Width: 7.3 Inch
• Height: 2 Inch
• Weight: 2.1 Pound
• Length: 9.6 Inch
• Width: 7.3 Inch
• Height: 2 Inch
• Weight: 2.1 Pound
• Length: 9.6 Inch
• Width: 7.3 Inch
• Height: 2 Inch
• Weight: 2.1 Pound
• Length: 9.6 Inch
• Width: 7.3 Inch
• Height: 2 Inch
• Weight: 2.1 Pound
• Length: 9.6 Inch
• Width: 7.3 Inch
• Height: 2 Inch

Operating and Storage Conditions

• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816486021381 [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: 2023-06-28
• Device Publish Date: 2023-06-20

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