LUMEX

Basic Information

• Brand Name: LUMEX
• Primary DI: M368DSHC700011
• Version / Model: DSHC70001
• Catalog Number: DSHC70001
• Company Name: GF HEALTH PRODUCTS, INC.
• Labeler DUNS: 132016168
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-06-07
• Public Version: 1
• Public Version Date: 2021-06-15
• Public Version Status: New
• Public Device Record Key: cf001a3b-8a6d-4e3b-814a-06efa4d34093

Device Description

PADDED HOYER-STYLE W/O SUP LG

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
FSA	Lift, Patient, Non-Ac-Powered	General Hospital	880.5510	1

GMDN Terms

Code	Name	Definition	Implantable	Status
37480	General-purpose patient lifting system sling/harness	A general-purpose lifting device used together with a patient lifting system to provide a support for an incapacitated patient or a person with a disability that is being lifted in a sitting position with their body (back, arms, buttocks and upper legs) held within the sling for transfer and (re)positioning. It is typcially constructed of straps, belts and material in which the occupant is cradled and contained during the lifting process; some types may employ additional straps, belts or vest-like harnesses to safely secure the occupant within the device. It typically has lifting straps or eyes that attach to a two-point, three-point or four-point spreader bar. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	M368DSHC700011	HIBCC

Customer Contacts

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