Eloquence 19683

GUDID 00816486021237

Eloquence iOS App

PRENTKE ROMICH COMPANY

Voice synthesizer/digitizer

• Primary Device ID: 00816486021237
• NIH Device Record Key: d6d7f7c1-05b9-41d5-805c-4a3fa96c837a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Eloquence
• Version Model Number: Eloquence App
• Catalog Number: 19683
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 800-262-1984
• Email: service@prc-saltillo.com
• Phone: 800-262-1984
• Email: service@prc-saltillo.com
• Phone: 800-262-1984
• Email: service@prc-saltillo.com
• Phone: 800-262-1984
• Email: service@prc-saltillo.com
• Phone: 800-262-1984
• Email: service@prc-saltillo.com
• Phone: 800-262-1984
• Email: service@prc-saltillo.com
• Phone: 800-262-1984
• Email: service@prc-saltillo.com
• Phone: 800-262-1984
• Email: service@prc-saltillo.com
• Phone: 800-262-1984
• Email: service@prc-saltillo.com
• Phone: 800-262-1984
• Email: service@prc-saltillo.com
• Phone: 800-262-1984
• Email: service@prc-saltillo.com
• Phone: 800-262-1984
• Email: service@prc-saltillo.com
• Phone: 800-262-1984
• Email: service@prc-saltillo.com
• Phone: 800-262-1984
• Email: service@prc-saltillo.com
• Phone: 800-262-1984
• Email: service@prc-saltillo.com
• Phone: 800-262-1984
• Email: service@prc-saltillo.com
• Phone: 800-262-1984
• Email: service@prc-saltillo.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816486021237 [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: 2023-11-16
• Device Publish Date: 2023-11-08

Devices Manufactured by PRENTKE ROMICH COMPANY

• 00816486021015 - Saltillo: 2023-11-16 TouchChat HD w/ WordPower App
• 00816486021022 - Saltillo: 2023-11-16 Classic TouchChat App
• 00816486021039 - Saltillo: 2023-11-16 Classic TouchChat w/ WordPower App
• 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