Accent 800

GUDID 00858526006743

Accent® 800 is an integrated speech device and offers advanced functionality and user-friendly features. It is the smallest and most portable PRC device that offers a variety of vocabulary options. The Accent 800 offers a choice of vocabulary options featuring Unity® with LAMP/Words for Life™, CoreScanner™, and WordCore. Other available vocabulary options include Essence™ for literate adults and WordPower™. The Accent 800 is powered by PRC’s NuVoice™ software and offers built in support resources for clinicians and clients.

PRENTKE ROMICH COMPANY

Voice synthesizer/digitizer

• Primary Device ID: 00858526006743
• NIH Device Record Key: 532934e4-cb44-4308-bf28-94ce5e014e1b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Accent 800
• Version Model Number: ACN800-40
• 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: 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: 2.45 Pound
• Weight: 2.45 Pound
• Weight: 2.45 Pound
• Weight: 2.45 Pound

Operating and Storage Conditions

• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00858526006743 [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: 2022-12-15
• Device Publish Date: 2022-12-07

On-Brand Devices [Accent 800]

• 00858526006651: Accent™ 800 is an integrated speech device and offers advanced functionality and user-friendly
• 00858526006040: Accent™ 800 is an integrated speech device and offers advanced functionality and user-friendly
• 00858526006743: Accent® 800 is an integrated speech device and offers advanced functionality and user-friendly