Catalog Number

-

Brand Name

FlexFlow Venous Cannula

Version/Model Number

200-200

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

K052081,K052081

Product Code

DWF

Product Code Name

Catheter, cannula and tubing, vascular, cardiopulmonary bypass

Public Device Record Key

59c00786-ac10-45e4-82db-28b125b705bf

Public Version Date

August 05, 2022

Public Version Number

2

DI Record Publish Date

September 28, 2020

Package DI Number

10803622147286

Quantity per Package

5

Contains DI Package

00803622147289

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE