Catalog Number

-

Brand Name

Capiox® RX Hollow Fiber Oxygenator with Hardshell Reservoir

Version/Model Number

3CX*RX25RE

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

K130333,K153213,K130333,K153213

Product Code

DTN

Product Code Name

Reservoir, Blood, Cardiopulmonary Bypass

Public Device Record Key

1f52dd51-b7e9-4c39-b778-2a1dc0c65eb3

Public Version Date

January 22, 2020

Public Version Number

4

DI Record Publish Date

October 01, 2015

Package DI Number

50699753450108

Quantity per Package

4

Contains DI Package

00699753450103

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

4 Piece Case