Catalog Number

-

Brand Name

Capiox® FX Hollow Fiber Oxygenator w Integrated Arterial Filter w Hardshell Res.

Version/Model Number

3CX*FX15RE30

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 01, 2018

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

K140774,K140774

Product Code

DTM

Product Code Name

Filter, Blood, Cardiopulmonary Bypass, Arterial Line

Public Device Record Key

04ea8459-408f-450c-b4dc-c87fb6b3660f

Public Version Date

January 22, 2020

Public Version Number

5

DI Record Publish Date

October 01, 2015

Package DI Number

50699753450443

Quantity per Package

4

Contains DI Package

00699753450448

Package Discontinue Date

December 01, 2018

Package Status

Not in Commercial Distribution

Package Type

4 Piece Case