Catalog Number

-

Brand Name

NX19 Oxygenator; left-side outlet port

Version/Model Number

3CX*NX19W

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

K180950,K180950

Product Code

DTR

Product Code Name

Heat-Exchanger, Cardiopulmonary Bypass

Public Device Record Key

3e535a78-9ed2-4e35-889d-31f91ca26e72

Public Version Date

March 26, 2021

Public Version Number

1

DI Record Publish Date

March 18, 2021

Package DI Number

50699753450894

Quantity per Package

4

Contains DI Package

00699753450899

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

4 Piece Case