Cofoe

Basic Information

• Brand Name: Cofoe
• Primary DI: 06950715501481
• Version / Model: KF-WAX-01
• Company Name: Cofoe Medical Technology Co.,Ltd
• Labeler DUNS: 544425204
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-06-25
• Public Version: 1
• Public Version Date: 2024-07-03
• Public Version Status: New
• Public Device Record Key: b4bde80d-dca3-48f4-a321-cbf23e6852c3
• Distribution End Date: 2030-04-27

Device Description

The Compression Socks are intended for use by individuals who require increased blood flow in the legs, such as those with venous insufficiency, varicose veins, or who are at risk of developing deep vein thrombosis (DVT). They are also suitable for individuals who spend long hours standing or sitting, such as nurses, office workers, or travelers.

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: 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
DWL	Stocking, Medical Support (To Prevent Pooling Of Blood In Legs)	General Hospital	880.5780	2

GMDN Terms

Code	Name	Definition	Implantable	Status
42811	Compression/pressure sock/stocking, reusable	A garment in the form of a sock or stocking intended to fit tightly over the leg and foot to apply compression/pressure (i.e., graduated or even-force), typically for the treatment/prevention of a disorder(s) of circulation [e.g., venous insufficiency, deep vein thrombosis (DVT)]. It is not a strip/roll binder or tubular support bandage, and is not designed to cover the pelvis. It is typically made of elastic material (e.g., circular knit nylon/Spandex yarns) and may be referred to as a flight sock; it does not include antimicrobial features. It is intended for use in the home or a clinical setting. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	06950715501481	GS1