UbiDuo

Basic Information

• Brand Name: UbiDuo
• Primary DI: 00850055523036
• Version / Model: UbiDuo 3 TTS1
• Company Name: S-Comm, Inc.
• Labeler DUNS: 556110935
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-10-17
• Public Version: 1
• Public Version Date: 2023-10-25
• Public Version Status: New
• Public Device Record Key: 83821a66-dff4-441d-864a-55b2ed664f7f

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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: No
• 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
65767	Assistive speech generator	An electrically-powered device designed to facilitate communication by a patient with a disability and/or cognitive impairment by providing buttons with images that when pressed produce audible pre-recorded words or phrases associated with the images. It is a unit with a set of buttons/keyboard displaying symbols/pictures, a recording function, and a speaker. It is intended for use both in the home and healthcare facility.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850055523036	GS1