Catalog Number

-

Brand Name

CAPIOX®ARTERIAL FILTER

Version/Model Number

CX*AF125X

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

-

Product Code

DTM

Product Code Name

Filter, Blood, Cardiopulmonary Bypass, Arterial Line

Public Device Record Key

e7ad1e8b-37c1-4778-a689-76f0bb241843

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 15, 2015

Package DI Number

54987350763353

Quantity per Package

10

Contains DI Package

04987350763358

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-