Catalog Number

5223230

Brand Name

Duet Long-Term Hemodialysis Catheter System

Version/Model Number

5223230

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Conditional

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

0b003d83-89de-4de6-9fb9-ca916399f337

Public Version Date

February 05, 2021

Public Version Number

3

DI Record Publish Date

May 06, 2015

Package DI Number

10801741011969

Quantity per Package

10

Contains DI Package

00801741011962

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CA