Chat Point

GUDID 00816486020001

Head pointing for Chat Fusion

PRENTKE ROMICH COMPANY

Voice synthesizer/digitizer

• Primary Device ID: 00816486020001
• NIH Device Record Key: 2db57a42-3d91-4656-bd65-9c5c8e3d2fec
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Chat Point
• Version Model Number: CP
• 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	00816486020001 [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: 2016-09-24

Devices Manufactured by PRENTKE ROMICH COMPANY

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• 00816486021053 - Saltillo: 2023-11-16 TouchChat HD App
• 00816486021060 - PRC: 2023-11-16 Quasselkiste App
• 00816486021077 - PRC: 2023-11-16 LAMP Words For Life (UK) App
• 00816486021084 - PRC: 2023-11-16 LAMP Words For Life (US) App
• 00816486021183 - PRC-Saltillo: 2023-11-16 Dialogue AAC App