Duns Number:428755441
Device Description: Disposable earloop face mask with 4 layers: two outer layers of hydrophobic PP spunbond, P Disposable earloop face mask with 4 layers: two outer layers of hydrophobic PP spunbond, PP submicron meltblown filter layer, inner layer of hydrophilic PP spunbond. Built-in nose bridge. Latex free.Application: for medical personnel and paramedics to ensure patient protection from microbial agents.Box of 50 masks. Colour: Aquamarine.
Catalog Number
217011
Brand Name
Monoart
Version/Model Number
Monoart Face Mask Protection Soft
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
a617389c-5b88-49c1-b6b9-2fc17f1c79ac
Public Version Date
March 28, 2022
Public Version Number
1
DI Record Publish Date
March 18, 2022
Package DI Number
E3072170111
Quantity per Package
50
Contains DI Package
E3072170110
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 |