Duns Number:122612547
Device Description: Electric Heat Pad, MaxHeat by SoftHeat, 12" x 24", 4 heat settings, 60 minute auto shut-of Electric Heat Pad, MaxHeat by SoftHeat, 12" x 24", 4 heat settings, 60 minute auto shut-off, moist heat. Machine wash entire pad.
Catalog Number
-
Brand Name
SoftHeat
Version/Model Number
HP980V1
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
3fb6ea8e-6af7-41c4-859c-82cfa6c0107c
Public Version Date
May 27, 2020
Public Version Number
3
DI Record Publish Date
July 29, 2016
Package DI Number
10328785000181
Quantity per Package
12
Contains DI Package
00328785000184
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 97 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 22 |