Duns Number:387209518
Device Description: The Exsudex® Wound Drainage Device is a compact, portable device indicated for patients wh
Catalog Number
3000700-RCIVAK
Brand Name
RCI VAK Wound Drainage Pump
Version/Model Number
XL
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
May 14, 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
c97d0574-182d-4f6e-87e3-0a20e3f3642b
Public Version Date
November 23, 2021
Public Version Number
4
DI Record Publish Date
January 26, 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 | 9 |