Duns Number:008965063
Device Description: Walgreens Cold & Hot Medicated Patch - Large, 5 Count
Catalog Number
-
Brand Name
WALGREENS
Version/Model Number
118137
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
Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
OMW
Product Code Name
Adhesive Backed Thermal Skin Patches
Public Device Record Key
fd9c92c2-3834-4399-903b-bd2e3aa5ce65
Public Version Date
September 20, 2021
Public Version Number
2
DI Record Publish Date
May 21, 2020
Package DI Number
30311917200065
Quantity per Package
6
Contains DI Package
00311917200064
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Intermediate
| 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 |