Catalog Number

TF3343O

Brand Name

Thin-Flex Dual Stage Venous Drainage Cannula

Version/Model Number

TF3343O

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

K120072,K120072

Product Code

DWF

Product Code Name

CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Public Device Record Key

2ed4392f-5fe7-4dd4-9369-bb31f8db537e

Public Version Date

August 05, 2022

Public Version Number

4

DI Record Publish Date

August 31, 2016

Package DI Number

50690103166458

Quantity per Package

10

Contains DI Package

00690103166453

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shipper