Duns Number:062312574
Device Description: Medical Grade Face Masks with Ear Loops, Blue
Catalog Number
-
Brand Name
CVS Health
Version/Model Number
465418
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
FXX
Product Code Name
Mask, Surgical
Public Device Record Key
3f57cca2-491a-4f8f-b78d-ca44d037e866
Public Version Date
March 11, 2022
Public Version Number
1
DI Record Publish Date
March 03, 2022
Package DI Number
20842942015964
Quantity per Package
24
Contains DI Package
10842942015967
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 | 82 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 139 |
| U | Unclassified | 23 |