LUMEX

Basic Information

• Brand Name: LUMEX
• Primary DI: M3687108A1
• Version / Model: 7108A
• Catalog Number: 7108A
• Company Name: GF HEALTH PRODUCTS, INC.
• Labeler DUNS: 132016168
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 4
• Record Status: Published
• Publish Date: 2021-08-12
• Public Version: 2
• Public Version Date: 2023-02-03
• Public Version Status: Update
• Public Device Record Key: acd5207d-a21b-4bb5-abe4-78887601967d

Device Description

COMMODE FOLDING STEEL

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
INN	Chair, Adjustable, Mechanical	Physical Medicine	890.3100	1

GMDN Terms

Code	Name	Definition	Implantable	Status
40539	Commode, manual	A non-active, manually-operated transportable device in the form of a chair with a built-in receptacle for collecting urine and faeces intended to enable a patient with a disability to urinate/defecate away from a bathroom or fixed toilet (e.g., during shower). Also known as a sanichair, it may include hydraulically-assisted seat height adjustment, and may or may not be supplied with wheels (castors).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	M3687108A0	HIBCC
Primary	M3687108A1	HIBCC

Customer Contacts

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