Duns Number:545255648
Device Description: BYD CARESingle-use Face MaskNon-sterileSoft & Easy to BreathBFE >= 98%PFE >= 98%Flammabili BYD CARESingle-use Face MaskNon-sterileSoft & Easy to BreathBFE >= 98%PFE >= 98%Flammability: Class IASTM Level 3Flat MaskSpecifications:175mm×95mm / 6.89in.×3.74in10pcs/bag ×5bags
Catalog Number
FE2311
Brand Name
BYD CARE
Version/Model Number
FE2311
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
December 31, 2050
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)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K200923
Product Code
FXX
Product Code Name
Mask, Surgical
Public Device Record Key
619c0176-6c92-4dbc-a6ab-e013dc74d55e
Public Version Date
September 14, 2020
Public Version Number
1
DI Record Publish Date
September 06, 2020
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. | 3 |