Duns Number:102726734
Device Description: Prevena Plus 125 Therapy UnitPrevena Plus 125 Therapy Unit with Prevena Plus 150ml Caniste Prevena Plus 125 Therapy UnitPrevena Plus 125 Therapy Unit with Prevena Plus 150ml Canister
Catalog Number
-
Brand Name
Prevena Plus™
Version/Model Number
PRE4000US
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
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"
-
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
8002c8fc-16e9-42b5-8b05-714fa6eeb7d4
Public Version Date
November 23, 2021
Public Version Number
5
DI Record Publish Date
September 21, 2017
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 63 |