Catalog Number

-

Brand Name

EasyFlow Duo Cannula

Version/Model Number

Duo Cannula

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"

-

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

K091542,K091542

Product Code

DWF

Product Code Name

Catheter, cannula and tubing, vascular, cardiopulmonary bypass

Public Device Record Key

04996bbc-07c5-4c25-91d8-8414db094462

Public Version Date

August 05, 2022

Public Version Number

2

DI Record Publish Date

January 11, 2021

Package DI Number

10803622147996

Quantity per Package

1

Contains DI Package

00803622147999

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE