Catalog Number

-

Brand Name

DUO-FLOW®

Version/Model Number

XTP114CT

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

4f94f394-5f4c-49c9-b9f9-878deb87efe2

Public Version Date

February 05, 2021

Public Version Number

6

DI Record Publish Date

November 13, 2015

Package DI Number

50884908058678

Quantity per Package

10

Contains DI Package

00884908058673

Package Discontinue Date

January 29, 2021

Package Status

Not in Commercial Distribution

Package Type

box