Duns Number:008965063
Device Description: Walgreens Moist Heat Wrap
Catalog Number
-
Brand Name
Walgreens
Version/Model Number
740699
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
Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
IME
Product Code Name
Pack, Hot Or Cold, Reusable
Public Device Record Key
94807354-db3c-48ef-bb27-134e79c53966
Public Version Date
May 08, 2020
Public Version Number
1
DI Record Publish Date
April 30, 2020
Package DI Number
10311917214822
Quantity per Package
8
Contains DI Package
00311917214825
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
corrugated 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 |