Monoart

Basic Information

• Brand Name: Monoart
• Primary DI: E3072170140
• Version / Model: Monoart Face Mask Protection Graffiti
• Catalog Number: 217014
• Company Name: EURONDA SPA
• Labeler DUNS: 428755441
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-04-10
• Public Version: 1
• Public Version Date: 2025-04-18
• Public Version Status: New
• Public Device Record Key: 3b8b60f4-15b7-429c-acdb-bd617f71b006

Device Description

Graffiti patterned disposable medical face masks, fluid resistant, ideal for aerosol and splash protection. Prevent airborne transmission of microorganisms and ensure excellent breathability, which exceeds the requirements of EN 14683. Equipped with an XTrap filter that captures bacteria and viruses for three times more protection and a particulate and antibacterial filter (99.8% filtration efficiency). Provided with comfortable rounded elastic bands and an elongated nose bridge with a double track for maximum stability. Box of 50 masks. Colour: pink with pattern

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: 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: 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
FXX	Mask, Surgical	General, Plastic Surgery	878.4040	2

GMDN Terms

Code	Name	Definition	Implantable	Status
66199	Surgical/medical face mask, non-antimicrobial, single-use	A flexible, loose-fitting mask designed to be placed over the mouth and/or nose of a healthcare worker to permit normal breathing while protecting the patient and wearer from the transfer of large particles (e.g., blood, body fluids, and airborne particulate materials). It does not include an antimicrobial/antiviral agent(s) and it is not a form-shaped filtering device (i.e., not a respirator). It is made of a flexible, porous fabric or paper material and is typically secured using elastic head straps or ties; it may incorporate a forming nosepiece (metal wire) and/or transparent face/eye visor. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	E3072170141	HIBCC	BOX	50	In Commercial Distribution
Primary	E3072170140	HIBCC
Package	E3072170142	HIBCC	CARTON	20	In Commercial Distribution