Duns Number:555324651
Device Description: 5-layer structurePrevention of respiratory infections and ultra-fine dust 2.5 PM.Electrost 5-layer structurePrevention of respiratory infections and ultra-fine dust 2.5 PM.Electrostatic filtration technology helps to filter up to 99, 98%Skin-friendly no woven fabricSmooth ear-strap.
Catalog Number
-
Brand Name
KF94 MEDICAL MASKS
Version/Model Number
1
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
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"
Yes
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
MSH
Product Code Name
Respirator, Surgical
Public Device Record Key
20002b77-f42d-4b09-8b4c-854556bc3850
Public Version Date
January 18, 2021
Public Version Number
1
DI Record Publish Date
January 09, 2021
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 2 |