Catalog Number

5323190

Brand Name

RELIANCE XK Long-Term Hemodialysis Catheter

Version/Model Number

5323190

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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"

Yes

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

MSD

Product Code Name

Catheter, hemodialysis, implanted

Public Device Record Key

3dde3c43-3ad6-44e4-a0b1-dc22c00c881d

Public Version Date

February 05, 2021

Public Version Number

3

DI Record Publish Date

May 27, 2015

Package DI Number

10801741011983

Quantity per Package

5

Contains DI Package

00801741011986

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CA