Catalog Number

OXY-1 PLU Disposable-US

Brand Name

OXY-1 System

Version/Model Number

OXY-1 PLU Disposable

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

K200109

Product Code

DTZ

Product Code Name

Oxygenator, Cardiopulmonary Bypass

Public Device Record Key

3eb109c2-b825-48b9-a544-6756eaf41ff2

Public Version Date

December 08, 2020

Public Version Number

1

DI Record Publish Date

November 30, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-