Duns Number:066689993
Device Description: BODYMED LED MOIST AND DRY HEATING PAD, 12" X 15"
Catalog Number
ZZHP1215E
Brand Name
BodyMed
Version/Model Number
ZZHP1215E
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
86a732be-c460-4ae4-99d7-886181e1ceb9
Public Version Date
February 27, 2020
Public Version Number
3
DI Record Publish Date
September 05, 2016
Package DI Number
20815802018726
Quantity per Package
24
Contains DI Package
10815802018729
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Master carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 23 |