Duns Number:008965063
Device Description: Walgreens Cone-Style Face Mask
Catalog Number
WRX153109
Brand Name
Well at Walgreens
Version/Model Number
WRX153109
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
November 30, 2020
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
5b99cf3c-1943-4737-9697-e16adb840df8
Public Version Date
August 16, 2021
Public Version Number
5
DI Record Publish Date
September 19, 2016
Package DI Number
10311917141951
Quantity per Package
240
Contains DI Package
20311917141958
Package Discontinue Date
November 30, 2020
Package Status
Not 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 |