Duns Number:008965063
Device Description: 3-ply Ear Loop Face Mask, Adult 50 ct
Catalog Number
-
Brand Name
Walgreens
Version/Model Number
129966
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
-
Product Code
FXX
Product Code Name
Mask, Surgical
Public Device Record Key
1e46a2e7-72cd-4e1e-96dd-bc6d126cbceb
Public Version Date
September 02, 2020
Public Version Number
1
DI Record Publish Date
August 25, 2020
Package DI Number
10311917221219
Quantity per Package
20
Contains DI Package
00311917221212
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 | 75 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 74 |
| U | Unclassified | 2 |