MERITS

Basic Information

• Brand Name: MERITS
• Primary DI: 04714379291513
• Version / Model: X901--CPMU
• Company Name: MERITS HEALTH PRODUCTS CO., LTD.
• Labeler DUNS: 657231924
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-06-27
• Public Version: 1
• Public Version Date: 2019-07-05
• Public Version Status: New
• Public Device Record Key: 44edcfa8-7f48-4952-9d80-ca77f70d6632

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: Yes
• 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: 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
KNO	Accessories, Wheelchair	Physical Medicine	890.3910	1

GMDN Terms

Code	Name	Definition	Implantable	Status
35086	Gas cylinder trolley	A dedicated cart designed to hold and secure one or more medical gas cylinders of compressed gas; but may be used for other types of gases, both during transport and static placement. The usual gases are [e.g., oxygen (O2), air, nitrous oxide (N2O) or helium (He)]. This trolley (cart) is used to prevent the cylinder(s) from falling both during transport and whilst the gas is being used. It is typically constructed of a metal framework [coated iron (Fe) or aluminium (Al)] and designed for standing upright on the floor when not in transport. It is configured to hold a certain size of gas cylinder(s) and will include a handle, a cylinder(s) securing device, and a pair of wheels.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04714379291513	GS1