Duns Number:779982974
Device Description: 3 PLY BACTERIAL FILTER FACE MASK ELASTIC EARLOOP- JELLY FISH (PURPLE)
Catalog Number
TS FM-P24146
Brand Name
THE SEA
Version/Model Number
TS FM-P24146
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)
-
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
6543a04d-a9fb-4c5f-b9e2-3551d64993c5
Public Version Date
March 09, 2022
Public Version Number
1
DI Record Publish Date
March 01, 2022
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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 177 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 13 |