Monoart - Disposable, hypo-allergenic face mask with 4 - EURONDA SPA

Duns Number:428755441

Device Description: Disposable, hypo-allergenic face mask with 4 layers: a soft water-repellent non-woven fabr Disposable, hypo-allergenic face mask with 4 layers: a soft water-repellent non-woven fabric for unparalleled protection from dust and moisture; PFE and BFE (Particle Filtration Efficiency and Bacterial Filtration Efficiency) filter > 99%; a polymeric filter for excellent fluid resistance, 120 mmHg; a comfortable absorbent hypoallergenic cellulose layer in contact with the skin, for effective absorption of sweat and humidity when used by operators. Built-in nose bridge Made with selected hypo-allergenic materials which have been carefully sourced to respect sensitive skins and avoid the risk of irritation and dermatitis. Box of 50 masks. Colour: Light blue.

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

217141

Brand Name

Monoart

Version/Model Number

Monoart Face Mask Protection 4 Sensitive

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

fcf0e471-4997-49f7-aaa0-0d4bd63b1e66

Public Version Date

May 06, 2020

Public Version Number

2

DI Record Publish Date

November 29, 2019

Additional Identifiers

Package DI Number

E3072171412

Quantity per Package

20

Contains DI Package

E3072171411

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CARTON

"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