Duns Number:783518983
Device Description: 12"x24" moist/dry electrical heating pad for household use.
Catalog Number
1034
Brand Name
Comfort Heal Heating Pad
Version/Model Number
JY6101
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
72457b78-99eb-4415-9d39-8a019b0efe3c
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
February 14, 2018
Package DI Number
10891237001031
Quantity per Package
12
Contains DI Package
00891237001034
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Outer Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 24 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 44 |
| U | Unclassified | 11 |