Duns Number:001315134
Device Description: Heating Pad
Catalog Number
-
Brand Name
Sunbeam
Version/Model Number
053891162838
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
833f7b34-86be-4a62-aca5-2c31fa22c65e
Public Version Date
June 03, 2021
Public Version Number
1
DI Record Publish Date
May 26, 2021
Package DI Number
30053891162839
Quantity per Package
6
Contains DI Package
00053891162838
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 |