Catalog Number

-

Brand Name

12F DUO-FLOW AND 14F DUO-FLOW 400XL CATHETER (SCHON XL/FEMORAL SIDEBYSIDE)

Version/Model Number

JT031401201

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

MPB

Product Code Name

Catheter, Hemodialysis, Non-Implanted

Public Device Record Key

d70a9da2-287d-4291-b872-d4e7ffbd993d

Public Version Date

February 05, 2021

Public Version Number

3

DI Record Publish Date

June 20, 2017

Package DI Number

50810988020953

Quantity per Package

10

Contains DI Package

00810988020958

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX