Duns Number:005146311
Device Description: Hemodialysis with XENIUM XPH Dialyzer is indicated for patients with acute or chronic rena Hemodialysis with XENIUM XPH Dialyzer is indicated for patients with acute or chronic renal failure when conservative therapy is judged to be inadequate. It also may be indicated in the treatment of patients intoxicated with poisons or drugs.
Catalog Number
H25604A
Brand Name
Xenium XPH Dialyzer
Version/Model Number
XPH170
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
September 01, 2017
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
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
KDI
Product Code Name
Dialyzer, high permeability with or without sealed dialysate system
Public Device Record Key
a5c9fbfd-eab4-467e-8517-99e71b6cbdca
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
October 07, 2015
Package DI Number
50085412090400
Quantity per Package
24
Contains DI Package
00085412090405
Package Discontinue Date
September 01, 2017
Package Status
Not in Commercial Distribution
Package Type
CASE
| 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. | 358 |