Handicare

Basic Information

• Brand Name: Handicare
• Primary DI: 00810045512198
• Version / Model: 400080
• Company Name: HANDICARE USA, INC.
• Labeler DUNS: 800145836
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-08-26
• Public Version: 1
• Public Version Date: 2020-09-03
• Public Version Status: New
• Public Device Record Key: afeb2129-eac1-4c90-a0ed-6f4f9eeaf3e8

Device Description

Medium Deluxe Stand Belt

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: 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
45382	Stand-up mobile patient lifting system sling/harness	A lifting device used together with a stand-up mobile lift system to provide a support for an incapacitated patient or a person with a disability that is being lifted from a sitting to a standing position for transfer, (re)positioning and use of a toilet. It is also used to support the patient/person in a standing position to assist in dressing them. It is designed as a sling/harness construction made of straps which is strapped around the person's chest and which will cradle and hold their body during the lifting process. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00810045512198	GS1