Chat Fusion

GUDID 00816486020018

Chat Fusion 8.1 is a speech generating device with an 8 inch screen. Fusion offers multiple access methods including Chat Point (optional headpointing), a front and rear camera, and extended battery life. Single or dual switch and advanced scanning features are incorporated into the device as well. Additionally, a wheelchair mounting plate has been included for your convenience.

PRENTKE ROMICH COMPANY

Voice synthesizer/digitizer

• Primary Device ID: 00816486020018
• NIH Device Record Key: 68b6dd86-c951-404f-924e-cad7cac49320
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Chat Fusion
• Version Model Number: CF8.1
• 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: false
• 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: aac@saltillo.com
• Phone: 9999999999
• Email: aac@saltillo.com
• Phone: 9999999999
• Email: aac@saltillo.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816486020018 [Primary]

FDA Product Code

• ILQ: System, Communication, Powered

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-02-13
• Device Publish Date: 2016-11-30

On-Brand Devices [Chat Fusion]

• 00816486020186: Set of 7 Keyguards for Chat Fusion 10.1 - 15 Location, 20 Location, 42 Location, 48 Location, 60
• 00816486020179: 15 Location Keyguard for Chat Fusion 10.1
• 00816486020162: 20 Location Keyguard for Chat Fusion 10.1
• 00816486020155: 42 Location Keyguard for Chat Fusion 10.1
• 00816486020148: 48 Location Keyguard for Chat Fusion 10.1
• 00816486020131: 60 Location Keyguard for Chat Fusion 10.1
• 00816486020124: 40 Location Keyguard for WordPower 80 file for Chat Fusion 10.1
• 00816486020117: 54 Location Keyguard for WordPower 108 file for Chat Fusion 10.1
• 00816486020100: 54 Location Keyguard for WordPower 108 file for Chat Fusion 8.1
• 00816486020094: 40 Location for WordPower 80 file Keyguard for Chat Fusion 8.1
• 00816486020087: 60 Location keyguard for Chat Fusion 8.1
• 00816486020070: 48 Location Keyguard for Chat Fusion 8.1
• 00816486020063: 42 Location Keyguard for Chat Fusion 8.1
• 00816486020056: 20 Location keyguard for Chat Fusion 8.1
• 00816486020049: 15 Location keyguard for Chat Fusion 8.1
• 00816486020032: Set of 7 Keyguards for Chat Fusion 8.1 - 15 Location, 20 Location, 42 Location, 48 Location, 6
• 00816486020025: Chat Fusion 10.1 is a speech generating device with a 10 inch screen. Chat Fusion offers wireles
• 00816486020018: Chat Fusion 8.1 is a speech generating device with an 8 inch screen. Fusion offers multiple acce