NovaChat NC10.7-84

GUDID 00816486021305

NovaChat 10.7 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

• Primary Device ID: 00816486021305
• NIH Device Record Key: b5c1ab8c-7366-4a33-8255-f1def0cd5672
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NovaChat
• Version Model Number: 19528-84
• Catalog Number: NC10.7-84
• 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

Customer Support Contacts

• Phone: 9999999999
• Email: acc@saltillo.com
• Phone: 9999999999
• Email: acc@saltillo.com
• Phone: 9999999999
• Email: acc@saltillo.com
• Phone: 9999999999
• Email: acc@saltillo.com
• Phone: 9999999999
• Email: acc@saltillo.com
• Phone: 9999999999
• Email: acc@saltillo.com
• Phone: 9999999999
• Email: acc@saltillo.com
• Phone: 9999999999
• Email: acc@saltillo.com
• Phone: 9999999999
• Email: acc@saltillo.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816486021305 [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: 2022-08-01
• Device Publish Date: 2022-07-22

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