Monoart

Basic Information

• Brand Name: Monoart
• Primary DI: E3072171200
• Version / Model: Monoart Face Mask Protection 3
• Catalog Number: 217120
• Company Name: EURONDA SPA
• Labeler DUNS: 428755441
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-11-29
• Public Version: 2
• Public Version Date: 2020-05-06
• Public Version Status: Update
• Public Device Record Key: 522b507c-d975-4c84-82ae-cbcd70493d54

Device Description

Disposable, hypo-allergenic face mask with 3 layers: • Soft, coloured and water-repellent non-woven fabric for improved protection against dust and humidity; • PFE (Particle Filtration Efficiency) filter and BFE (Bacterial Filtration Efficiency) filter > 99%; • Comfortable non-woven cotton lining for extra absorbance of sweat and humidity. It is ideal for protection from dust and aerosols: ΔP<3.0 mm H2O/cm2 in accordance with the EN 14683 standard (differential pressure: surgical mask breathability rating). Built-in nose bridge. Colour: Lime Box of 50 masks

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
35177	Surgical/medical face mask, 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) during medical procedures and patient examination; 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 intended to protect the upper face/eyes from debris/fluid. This is a single-use device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	E3072171200	HIBCC
Package	E3072171201	HIBCC	BOX	50	In Commercial Distribution
Package	E3072171202	HIBCC	CARTON	20	In Commercial Distribution