Catalog Number

5913350

Brand Name

EQUISTREAM XK Long-Term Hemodialysis Catheter with Preloaded Stylet

Version/Model Number

5913350

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"

-

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

a9600274-3363-4573-810f-87052945ab0f

Public Version Date

February 05, 2021

Public Version Number

3

DI Record Publish Date

May 04, 2015

Package DI Number

10801741013871

Quantity per Package

5

Contains DI Package

00801741013874

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CA