Tobii Dynavox

Basic Information

• Brand Name: Tobii Dynavox
• Primary DI: 07340074601035
• Version / Model: I-13
• Catalog Number: 12006976
• Company Name: TOBII DYNAVOX LLC
• Labeler DUNS: 119127942
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-10-21
• Public Version: 2
• Public Version Date: 2020-03-04
• Public Version Status: Update
• Public Device Record Key: 66ae0044-aa29-470b-be02-af79ff247fa5

Device Description

Speech Generating Device with Eye tracking capability - 13" screen size

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
ILQ	System, Communication, Powered	Physical Medicine	890.3710	2

GMDN Terms

Code	Name	Definition	Implantable	Status
17187	Voice synthesizer/digitizer	An assistive device designed to deliver voice output based either in the reproduction of previously-recorded natural speech and/or on an electronic synthesized voice following a pre-established set of pronunciation rules. It typically consists of an electronic unit with a keyboard and screen; the keyboard may include letters, symbols, or both. The device is often customized to meet the user?s needs and is mostly used by patients with disabilities that partially or totally impair voice capabilities, including chronic progressive diseases.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07340074601035	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]