Copioumed

Basic Information

• Brand Name: Copioumed
• Primary DI: 04719882250620
• Version / Model: SHN0B101-1
• Company Name: COPIOUMED INTERNATIONAL INC.
• Labeler DUNS: 658318113
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 100
• Record Status: Published
• Publish Date: 2022-09-02
• Public Version: 1
• Public Version Date: 2022-09-12
• Public Version Status: New
• Public Device Record Key: 7b325834-bdeb-4c67-8cee-c4f55b75fd6e

Device Description

Copioumed’s Spunbond Shoe Covers offer a protective covering for shoes worn in the healthcare facility. They help minimize contamination and prevent the transmission of microorganisms between staff and patients and hospital-acquired complications.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• 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: 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
BWP	Shoe And Shoe Cover, Conductive	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	14719882250627	GS1	Carton	20	In Commercial Distribution
Primary	04719882250620	GS1
Unit of Use	04719882250613	GS1

Customer Contacts

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