Duns Number:006961700
Device Description: Up&Up Heat Wrap - Back/Large Areas, 3 count
Catalog Number
48-970
Brand Name
Up & Up
Version/Model Number
245-07-1174
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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
OMW
Product Code Name
Adhesive Backed Thermal Skin Patches
Public Device Record Key
a957e351-16d6-45b2-8505-f7a94db0efd7
Public Version Date
June 21, 2019
Public Version Number
1
DI Record Publish Date
June 13, 2019
Package DI Number
30845717009363
Quantity per Package
3
Contains DI Package
00845717009362
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 | 22 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 52 |
| U | Unclassified | 12 |