Xenium XPH Dialyzer - Hemodialysis with XENIUM XPH Dialyzer is - BAXTER INTERNATIONAL INC.

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.

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

H25602A

Brand Name

Xenium XPH Dialyzer

Version/Model Number

XPH130

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 01, 2018

Issuing Agency

In GS1

Product Characteristics

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 Details

Product Code

KDI

Product Code Name

Dialyzer, high permeability with or without sealed dialysate system

Device Record Status

Public Device Record Key

b773a3b9-e739-44ac-8559-cf1937fd278c

Public Version Date

September 03, 2018

Public Version Number

3

DI Record Publish Date

October 07, 2015

Additional Identifiers

Package DI Number

50085412090387

Quantity per Package

24

Contains DI Package

00085412090382

Package Discontinue Date

September 01, 2018

Package Status

Not in Commercial Distribution

Package Type

CASE

"BAXTER INTERNATIONAL INC." Characteristics
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