AccessGUDID - DEVICE: Monoart (E3072170120)

GUDID

Device Identifier (DI) Information

Brand Name: Monoart
Version or Model: Monoart Face Mask Protection Graffiti
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 217012
Company Name: EURONDA SPA

Primary DI Number: E3072170120
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 428755441 *Terms of Use

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: Light blue with pattern

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FXX	Mask, Surgical

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: e2843afd-17f4-40d3-ad98-7aa4874226e2
Public Version Date: April 18, 2025
Public Version Number: 1
DI Record Publish Date: April 10, 2025