Duns Number:008965063
Device Description: Walgreens Earloop Face Mask
Catalog Number
WRX153107
Brand Name
Well at Walgreens
Version/Model Number
WRX153107
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
d9db7fbb-31d4-46a3-80c2-7ea57e0731b3
Public Version Date
June 19, 2020
Public Version Number
4
DI Record Publish Date
September 19, 2016
Package DI Number
10311917141944
Quantity per Package
600
Contains DI Package
20311917141941
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 |