GENDRON

Basic Information

• Brand Name: GENDRON
• Primary DI: M368GT5XL1
• Version / Model: GT5XL
• Company Name: GF HEALTH PRODUCTS, INC.
• Labeler DUNS: 132016168
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-12-04
• Public Version: 1
• Public Version Date: 2023-12-12
• Public Version Status: New
• Public Device Record Key: 51fbaaf7-b265-41fa-905c-65984358f7b0

Device Description

SLING,BARIATRIC (400-1000 LBS)

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: 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
FNG	Lift, Patient, Ac-Powered	General Hospital	880.5500	2

GMDN Terms

Code	Name	Definition	Implantable	Status
40535	Solid-seat mobile patient lifting system seat	A lifting device used together with a solid-seat mobile lifting system to provide a support for an incapacitated patient or a person with a disability that is being lifted in a sitting position for transfer and (re)positioning. It is designed as a seat with a solid surface (this may be padded) upon which the person to be lifted is sat and contained during the lifting process.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	M368GT5XL1	HIBCC

Customer Contacts

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