Catalog Number

-

Brand Name

Duo-Flow®XTP

Version/Model Number

AAC02107

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 28, 2020

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

c7a1e564-4d2d-4e38-943a-7c7229bc1e2b

Public Version Date

June 18, 2021

Public Version Number

6

DI Record Publish Date

November 14, 2015

Package DI Number

50884908000196

Quantity per Package

5

Contains DI Package

00884908000191

Package Discontinue Date

September 28, 2020

Package Status

Not in Commercial Distribution

Package Type

box