Lumex

Basic Information

• Brand Name: Lumex
• Primary DI: M368STS500M1
• Version / Model: STS500M
• Catalog Number: STS500M
• Company Name: GF HEALTH PRODUCTS, INC.
• Labeler DUNS: 132016168
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-10-07
• Public Version: 2
• Public Version Date: 2021-11-23
• Public Version Status: Update
• Public Device Record Key: 49d6b29c-e2fe-421b-9593-db26cd8fee9d

Device Description

Lift Sit to Stand

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: Yes
• Has Lot/Batch Number: No
• 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
FNG	Lift, Patient, Ac-Powered	General Hospital	880.5500	2

GMDN Terms

Code	Name	Definition	Implantable	Status
45386	Stand-up mobile patient lifting system, manual	A non-powered, mobile assembly of devices designed to enable one person to lift an incapacitated patient or a person with a disability from a sitting position into a standing position and then move them from one place to another by physically pushing it with minimal effort with the occupant held secured in the standing position. Also known as a stand-up hoist or standing hoist, it typically consists of a support base on wheels with lifting mechanism, a footrest (footplate), knee/leg supports, a sling/harness, and a mechanism that provides mechanical advantage (e.g., using pneumatic springs).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	M368STS500M1	HIBCC

Customer Contacts

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