Merits

Basic Information

• Brand Name: Merits
• Primary DI: 00835246004594
• Version / Model: P325I1AARMUB
• Catalog Number: P325I1AARMUB
• Company Name: Merits Health Products, Inc.
• Labeler DUNS: 879307148
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-10-01
• Public Version: 1
• Public Version Date: 2024-10-09
• Public Version Status: New
• Public Device Record Key: 6e56bc4c-c6b3-471e-bd55-741185d05fa5

Device Description

Vision Ultra, Red with Captain 18" CST

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• 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: No
• 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
ITI	Wheelchair, Powered	Physical Medicine	890.3860	2

GMDN Terms

Code	Name	Definition	Implantable	Status
41875	Electric-motor-driven wheelchair, occupant-controlled	An electrically-powered wheeled personal mobility device with a seat designed to enable a non-bariatric person with a disability, or without the full capacity to walk, to self-mobilize using power from an electric motor(s). It includes controls (typically joystick) to allow the occupant electronic control of speed/direction; it is not designed with a foot platform and handlebars (i.e., not a mobility scooter).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00835246004594	GS1

Premarket Submissions

Submission Number	Supplement Number
K012802	000