Copioumed

Basic Information

• Brand Name: Copioumed
• Primary DI: 04719882253164
• Version / Model: SHN0W111-1
• Company Name: Copious International Inc.
• Labeler DUNS: 527237481
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 100
• Record Status: Published
• Publish Date: 2023-08-25
• Public Version: 1
• Public Version Date: 2023-09-04
• Public Version Status: New
• Public Device Record Key: 8f3a2dd6-7c90-4c39-80c6-131353aadc6e

Device Description

Copioumed The shoe cover is composed of non-woven fabric and latex elastic band, which is widely used in electronics, chemical industry, dust-free workshop, clean room, and other high-demand environment, dustproof.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: Yes
• 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
FXP	Cover, Shoe, Operating-Room	General, Plastic Surgery	878.4040	1

GMDN Terms

Code	Name	Definition	Implantable	Status
15056	Shoe cover	A loose fabric covering intended to be placed over a shoe to create a physical barrier to maintain hygiene and prevent cross-contamination of microorganisms, body fluids, and particulate material between the shoe and the environment, or a patient and staff. It is typically used in areas such as examination rooms or operating theatres and may be conductive, to reduce the risk of static electricity, or non-conductive. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	14719882253161	GS1	Carton	12	In Commercial Distribution
Primary	04719882253164	GS1
Unit of Use	04719882253157	GS1

Customer Contacts

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