Duns Number:008965063
Device Description: Walgreens 3 ply Ear Loop Face Mask 3 ct
Catalog Number
-
Brand Name
Well at Walgreens
Version/Model Number
255914
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
LYU
Product Code Name
Accessory, Surgical Apparel
Public Device Record Key
beda38cd-6b52-47d3-922d-ce41978eecb8
Public Version Date
December 07, 2020
Public Version Number
1
DI Record Publish Date
November 27, 2020
Package DI Number
10311917221363
Quantity per Package
320
Contains DI Package
00311917221366
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 |