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.Colour: WhiteBox of 50 masks
Catalog Number
217118
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
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
FXX
Product Code Name
Mask, Surgical
Public Device Record Key
318ad9f1-cd6f-4d8b-9242-6eec2acce49a
Public Version Date
May 06, 2020
Public Version Number
2
DI Record Publish Date
November 29, 2018
Package DI Number
E3072171181
Quantity per Package
50
Contains DI Package
E3072171180
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BOX
| 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 |