Duns Number:078497467
Device Description: Heating Pad
Catalog Number
211.71
Brand Name
Beurer
Version/Model Number
UHP26
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
d6a7924f-e55b-4ade-bc62-dfd1fa9e68f2
Public Version Date
August 11, 2020
Public Version Number
1
DI Record Publish Date
August 03, 2020
Package DI Number
10850003500765
Quantity per Package
4
Contains DI Package
00850003500768
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case Pack
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 7 |
2 | A medical device with a moderate to high risk that requires special controls. | 90 |
U | Unclassified | 2 |