Catalog Number

-

Brand Name

Soft-Line® Duo-Flow

Version/Model Number

T119M

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

801e968f-7890-410a-8c66-05736d354726

Public Version Date

February 10, 2021

Public Version Number

4

DI Record Publish Date

April 30, 2016

Package DI Number

50884908056803

Quantity per Package

5

Contains DI Package

00884908056808

Package Discontinue Date

January 29, 2021

Package Status

Not in Commercial Distribution

Package Type

box