Catalog Number

-

Brand Name

Capiox® FX Advance Hollow Fiber Oxygenator w Integrated AF w Hardshell Res.

Version/Model Number

3CX*FX15RW40C

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

K151791,K151791

Product Code

DTM

Product Code Name

Filter, Blood, Cardiopulmonary Bypass, Arterial Line

Public Device Record Key

67d593b8-2dfa-4adc-8077-245171f24c55

Public Version Date

January 22, 2020

Public Version Number

4

DI Record Publish Date

January 20, 2016

Package DI Number

50699753450795

Quantity per Package

4

Contains DI Package

00699753450790

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

4 Piece Case