Catalog Number

-

Brand Name

Duo-Flow®

Version/Model Number

MCDLT4424#

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 16, 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

Yes

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

21c5c45c-1314-4be4-a611-1c77eb6f4d27

Public Version Date

September 16, 2021

Public Version Number

7

DI Record Publish Date

November 14, 2015

Package DI Number

50884908026462

Quantity per Package

5

Contains DI Package

00884908026467

Package Discontinue Date

August 16, 2021

Package Status

Not in Commercial Distribution

Package Type

box