EXPRESSION

Basic Information

• Brand Name: EXPRESSION
• Primary DI: G549SUPREME0
• Version / Model: SUPREME
• Company Name: Rcs Management Corp
• Labeler DUNS: 119066352
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-11-21
• Public Version: 1
• Public Version Date: 2024-11-29
• Public Version Status: New
• Public Device Record Key: 34f48b93-2cd1-4786-980c-daebf883dd0f

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: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: Yes

Sterilization

• Is Sterile: Yes
• 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	G549SUPREME0	HIBCC