LUMEX

Basic Information

• Brand Name: LUMEX
• Primary DI: M3687921A41
• Version / Model: 7921A-4
• Catalog Number: 7921A-4
• 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: 1
• Public Version Date: 2021-08-20
• Public Version Status: New
• Public Device Record Key: 1cc18fd3-837b-48a5-9a12-42b83c735759

Device Description

BATH SEAT W/ BACK (4/CS)

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
41069	Bath back rest/seat	A device designed to support the back, and sometimes buttocks, of a patient (usually an adult) who is bathing in a bath (usually while being attended/assisted) to enable the patient to sit in an upright, and sometimes elevated, position in the bath. The patient is typically disabled, infirm, or undergoing medical treatment and cannot sit normally in a bath. The device may be a back rest only or a seat with an incorporated back rest, typically made of water-resistant or waterproof materials; it may be laid across the rim of the bath or secured to the bath. The device may be used in a hospital, institution, or home.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	M3687921A40	HIBCC
Primary	M3687921A41	HIBCC

Customer Contacts

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