Catalog Number

MCDLT4424#

Brand Name

Duo-Flow®

Version/Model Number

MCDLT4424#

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

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

e60fc1a3-754b-43b7-938e-798a9e4c563a

Public Version Date

August 26, 2021

Public Version Number

1

DI Record Publish Date

August 18, 2021

Package DI Number

50884908162931

Quantity per Package

5

Contains DI Package

00884908162936

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box