Catalog Number

EZF24TA

Brand Name

Edwards Lifesciences EZ Glide Aortic Cannula

Version/Model Number

EZF24TA

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

K123370,K123370

Product Code

DWF

Product Code Name

CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Public Device Record Key

675fa2a0-3ec4-4bca-bf4f-3bb5ca804776

Public Version Date

August 05, 2022

Public Version Number

4

DI Record Publish Date

August 31, 2016

Package DI Number

50690103175078

Quantity per Package

10

Contains DI Package

00690103175073

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shipper