Catalog Number

-

Brand Name

EOS PMP

Version/Model Number

Oxygenator

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

K150489,K150489

Product Code

DTZ

Product Code Name

OXYGENATOR, CARDIOPULMONARY BYPASS

Public Device Record Key

994f09fb-da80-4045-8faa-6e3209149c0c

Public Version Date

January 22, 2020

Public Version Number

4

DI Record Publish Date

June 26, 2015

Package DI Number

38033178112742

Quantity per Package

2

Contains DI Package

08033178112741

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX