Catalog Number

DF50SH55K

Brand Name

Decathlon DF Long-Term Hemodialysis Catheter

Version/Model Number

DF50SH55K

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

c62eebe7-595b-407a-81aa-cd21a6362982

Public Version Date

February 05, 2021

Public Version Number

3

DI Record Publish Date

May 27, 2015

Package DI Number

10801741014045

Quantity per Package

5

Contains DI Package

00801741014048

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CA