Catalog Number

-

Brand Name

Capiox® Hardshell Reservoir

Version/Model Number

CX*SXRX

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

K130359,K130359

Product Code

DTZ

Product Code Name

Oxygenator, Cardiopulmonary Bypass

Public Device Record Key

b1575053-c761-40cc-9876-f6b078f66a59

Public Version Date

January 22, 2020

Public Version Number

5

DI Record Publish Date

October 02, 2015

Package DI Number

50699753450160

Quantity per Package

4

Contains DI Package

00699753450165

Package Discontinue Date

December 01, 2018

Package Status

Not in Commercial Distribution

Package Type

4 Piece Case