Duns Number:715288182
Device Description: The mask materials include four layers, the inner and outer layers are made of spun-bond p
Catalog Number
-
Brand Name
CCW
Version/Model Number
Expanded chamber, Longitudinal fold, ear strap, 4 layers
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"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K212205
Product Code
FXX
Product Code Name
Mask, Surgical
Public Device Record Key
c16c697d-7872-4d18-8b22-c66353b3953f
Public Version Date
November 12, 2021
Public Version Number
1
DI Record Publish Date
November 04, 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 |