AccessGUDID - DEVICE: Monoart (E3072171160)

GUDID

Device Identifier (DI) Information

Brand Name: Monoart
Version or Model: Monoart Face Mask Protection 3
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 217116
Company Name: EURONDA SPA

Primary DI Number: E3072171160
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 428755441 *Terms of Use

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. Box of 50 masks Colour: Yellow

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?
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.	Obsolete	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: 44128851-33f5-46f1-bd4b-4620b28440c7
Public Version Date: May 06, 2020
Public Version Number: 2
DI Record Publish Date: November 29, 2018