Catalog Number

-

Brand Name

NX19 West Sub-Assembly-Japan Only, Export Only

Version/Model Number

CXOT281

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

5d1fe66c-6409-4c94-93d7-73885bb4a8c5

Public Version Date

March 29, 2021

Public Version Number

1

DI Record Publish Date

March 19, 2021

Package DI Number

50699753451013

Quantity per Package

4

Contains DI Package

00699753451018

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

4 Piece Case