Duns Number:008965063
Device Description: Heating Therapy Wrap, Walgreens, AccuHeatt technology, Tan
Catalog Number
692207
Brand Name
Walgreens
Version/Model Number
MOB951S.WLG
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
-
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
IRT
Product Code Name
Pad, Heating, Powered
Public Device Record Key
36e6d2e5-e4b3-4628-ae4d-60115cca2e80
Public Version Date
July 07, 2020
Public Version Number
3
DI Record Publish Date
April 08, 2020
Package DI Number
10311917214488
Quantity per Package
9
Contains DI Package
00311917214481
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| 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 |