Duns Number:093992526
Device Description: Large Black Foam Negative Pressure Wound Therapy Dressing Kit
Catalog Number
-
Brand Name
Negative Pressure Wound Therapy System Foam Dressing
Version/Model Number
UN25163L
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
MRI safety Status
MR Unsafe
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"
Yes
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
OMP
Product Code Name
Negative Pressure Wound Therapy Powered Suction Pump
Public Device Record Key
8d94cfdc-77ef-4a20-8947-a9c831fa4df8
Public Version Date
June 19, 2020
Public Version Number
2
DI Record Publish Date
February 11, 2019
Package DI Number
B530UN25163L1
Quantity per Package
20
Contains DI Package
B530UN25163L0
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 3 |