Catalog Number

-

Brand Name

DUO-FLOW®

Version/Model Number

XTP119CT

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

January 29, 2021

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

KNZ

Product Code Name

Accessories, a-v shunt

Public Device Record Key

5a11a4a6-ae7b-48c9-817f-2e913c364a26

Public Version Date

February 05, 2021

Public Version Number

6

DI Record Publish Date

November 13, 2015

Package DI Number

50884908060022

Quantity per Package

10

Contains DI Package

00884908060027

Package Discontinue Date

January 29, 2021

Package Status

Not in Commercial Distribution

Package Type

box