Duns Number:043081723
Device Description: ADVOCATE HEATING PAD KING SIZE 12"X 24" AUTO TURN OFF 4 HEAT SETTINGS
Catalog Number
JY6101
Brand Name
ADVOCATE HEATING PAD KING SIZE
Version/Model Number
315
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
74419ef7-eea0-4408-853a-d505a6a1cca7
Public Version Date
July 13, 2020
Public Version Number
3
DI Record Publish Date
March 10, 2017
Package DI Number
20894046001145
Quantity per Package
12
Contains DI Package
00894046001141
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
315-C
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 6 |