LUMEX

Basic Information

• Brand Name: LUMEX
• Primary DI: M368GF1840C21
• Version / Model: GF1840C-2
• Catalog Number: GF1840C-2
• Company Name: GF HEALTH PRODUCTS, INC.
• Labeler DUNS: 132016168
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 2
• Record Status: Published
• Publish Date: 2021-06-08
• Public Version: 1
• Public Version Date: 2021-06-16
• Public Version Status: New
• Public Device Record Key: 17763215-ddfb-4e7a-b54b-480062aeeea6

Device Description

STOOL SAFETY STEP W/LONG HNDL

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
FZM	Stool, Operating-Room	General, Plastic Surgery	878.4950	1

GMDN Terms

Code	Name	Definition	Implantable	Status
11772	Footstool	A platform, with or without legs, designed for a person to stand upon to compensate for differences in height or to place the feet/legs upon for rest/support when seated. It may be conductive to reduce the risk of static electricity when used in areas such as examination rooms or operating theatres, or non-conductive.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	M368GF1840C20	HIBCC
Primary	M368GF1840C21	HIBCC

Customer Contacts

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