Duns Number:387209518
Device Description: The Exsudex® Wound Drainage Device is a compact, portable device indicated for patients wh The Exsudex® Wound Drainage Device is a compact, portable device indicated for patients who would benefit from theapplication of negative pressure to the area of a wound, for the aspiration and removal of surgical fluids, irrigation fluids, tissue(including bone), gases, bodily fluids or infectious materials either during surgery or at the patient’s bedside particularly as thedevice may promote wound healing.
Catalog Number
3000800-IHT
Brand Name
NEWERA II Wound Drainage Pump
Version/Model Number
XS
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
July 09, 2018
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
-
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
-
Product Code Name
-
Public Device Record Key
ee94b813-0769-4315-9c74-1bee158fcef7
Public Version Date
November 23, 2021
Public Version Number
4
DI Record Publish Date
October 26, 2016
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 | 9 |