Monoart - Disposable, hypo-allergenic face mask with 3 - EURONDA SPA

Duns Number:428755441

Device Description: Disposable, hypo-allergenic face mask with 3 layers:• Soft, coloured and water-repellent n 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.Color: green

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More Product Details

Catalog Number

217114

Brand Name

Monoart

Version/Model Number

Monoart Face Mask Protection 3

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

Product Characteristics

MRI safety Status

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)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

FXX

Product Code Name

Mask, Surgical

Device Record Status

Public Device Record Key

c29ef95e-d996-4f44-b565-89675d5a2d35

Public Version Date

May 06, 2020

Public Version Number

2

DI Record Publish Date

November 29, 2018

Additional Identifiers

Package DI Number

E3072171141

Quantity per Package

50

Contains DI Package

E3072171140

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX

"EURONDA SPA" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 126
2 A medical device with a moderate to high risk that requires special controls. 12