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 non-woven cotton lining for extra absorbance of sweat and humidity when used by operators. Built-in nose bridge.Box of 50 masks. Colour: Light blue.
Catalog Number
217132
Brand Name
Monoart
Version/Model Number
Monoart Face Mask Protection 4
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
b26483ff-fddb-48ed-9564-b1261dbc3484
Public Version Date
May 06, 2020
Public Version Number
2
DI Record Publish Date
November 28, 2019
Package DI Number
E3072171322
Quantity per Package
20
Contains DI Package
E3072171321
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CARTON
| 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 |