Catalog Number

-

Brand Name

Capiox® SX Hollow Fiber Oxygenator with Hardshell Reservoir

Version/Model Number

CX*SX18RX

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

K130359,K153140,K130359,K153140

Product Code

DTN

Product Code Name

Reservoir, Blood, Cardiopulmonary Bypass

Public Device Record Key

bbe5d247-357c-4bcc-a7c2-f47875bedc7f

Public Version Date

January 22, 2020

Public Version Number

4

DI Record Publish Date

October 01, 2015

Package DI Number

50699753450054

Quantity per Package

4

Contains DI Package

00699753450059

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

4 Piece Case