LUMEX

Basic Information

• Brand Name: LUMEX
• Primary DI: M368US0468PKG1
• Version / Model: US0468-PKG
• Company Name: GF HEALTH PRODUCTS, INC.
• Labeler DUNS: 114107329
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-08-31
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 62f9ba54-9962-46de-8d9e-bac44d7f663b

Device Description

Patriot Homecare Bed

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: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• 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
LLI	Bed, Therapeutic, Ac-Powered, Adjustable Home-Use	General Hospital	880.5100	2

GMDN Terms

Code	Name	Definition	Implantable	Status
46365	Basic electric home bed	A mains electricity (AC-powered) motorized bed designed to be used in the home by a patient for rest/sleep, and that provides the occupant with touch button adjustment possibilities. It typically includes a framework with wheels, a mattress support platform that can articulate, a headboard and footboard and a remote control to operate the electrical motors. The device typically raises the torso and/or legs to various heights. It may also include a heatable mattress and physical therapy pulsators.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	M368US0468PKG1	HIBCC

Customer Contacts

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