Lumex

Basic Information

• Brand Name: Lumex
• Primary DI: M3686484R21
• Version / Model: 6484R-2
• Catalog Number: 6484R-2
• Company Name: GF HEALTH PRODUCTS, INC.
• Labeler DUNS: 132016168
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-09-22
• Public Version: 1
• Public Version Date: 2020-09-30
• Public Version Status: New
• Public Device Record Key: e9069c55-a297-4bca-8a11-1110bc6fffac

Device Description

Raised Toliet Seat Cushion

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: No
• Has Lot/Batch Number: Yes
• 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
INB	Attachment, Commode, Wheelchair	Physical Medicine	890.3920	1

GMDN Terms

Code	Name	Definition	Implantable	Status
35631	Toilet cushion	A soft pillow or pad designed to provide support, comfort, and assistance to the user while sitting on a toilet or commode seat. The device is designed to evenly distribute body weight, absorb shock, and adjust height for the user who has difficulty bending to or rising from a low position.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	M3686484R22	HIBCC	Box	2	In Commercial Distribution
Primary	M3686484R21	HIBCC

Customer Contacts

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