Duns Number:008965063
Device Description: Walgreens Instant Cold Pack 8 ct
Catalog Number
-
Brand Name
Walgreens
Version/Model Number
998353
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
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
IMD
Product Code Name
Pack, Hot Or Cold, Disposable
Public Device Record Key
a08564d0-7efe-419d-9963-bbed0676d4e0
Public Version Date
June 18, 2020
Public Version Number
1
DI Record Publish Date
June 10, 2020
Package DI Number
10311917194971
Quantity per Package
3
Contains DI Package
00311917194974
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
case pack
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 |