Duns Number:001315134
Device Description: Heated Mattress Pad
Catalog Number
-
Brand Name
Sunbeam
Version/Model Number
MSU7RTS-C000-15A38
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)
-
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
a3b964b3-dc0c-45a7-88ed-b5d516ab58d4
Public Version Date
July 07, 2020
Public Version Number
3
DI Record Publish Date
September 22, 2016
Package DI Number
10027045777534
Quantity per Package
2
Contains DI Package
00027045777537
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 23 |
2 | A medical device with a moderate to high risk that requires special controls. | 164 |