Duns Number:004135503
Device Description: Clever Choice Disposable Face Masks - Medical
Catalog Number
-
Brand Name
Clever Choice
Version/Model Number
Face Mask
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)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K211363,K211363,K211363
Product Code
FXX
Product Code Name
Mask, Surgical
Public Device Record Key
9f4efa7c-1e62-47cc-a355-5f33b377b8f5
Public Version Date
January 12, 2022
Public Version Number
1
DI Record Publish Date
January 04, 2022
Package DI Number
10898302140190
Quantity per Package
40
Contains DI Package
00898302140193
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 2 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 19 |