Cathay

Basic Information

• Brand Name: Cathay
• Primary DI: 06959006303544
• Version / Model: CM5050FC
• Company Name: CATHAY MANUFACTURING CORP.
• Labeler DUNS: 421287342
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 4
• Record Status: Published
• Publish Date: 2021-11-25
• Public Version: 2
• Public Version Date: 2023-02-20
• Public Version Status: Update
• Public Device Record Key: d9681e25-6d64-49e9-be92-39b6364adde6

Device Description

TENs Electrodes

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: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GXY	Electrode, Cutaneous	Neurology	882.1320	2

GMDN Terms

Code	Name	Definition	Implantable	Status
65319	Electrode conductive skin pad, reusable	A noninvasive conductive material designed to facilitate electrical conduction between an external electrode (e.g., transcutaneous electrical stimulation electrode) and the skin surface. It is typically in the form of a gel pad/patch designed to adhere the electrode (not included) to the skin surface. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	16959006303541	GS1	Box	100	In Commercial Distribution
Primary	06959006303544	GS1
Package	26959006303548	GS1	case	8	In Commercial Distribution
Unit of Use	36959006303545	GS1

Customer Contacts

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