Catalog Number

-

Brand Name

NA

Version/Model Number

1475R1

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K800178,K800178

Product Code

DRY

Product Code Name

MONITOR, BLOOD-GAS, ON-LINE, CARDIOPULMONARY BYPASS

Public Device Record Key

c7a9208a-266e-488e-a0f2-ec092220b3b6

Public Version Date

January 22, 2020

Public Version Number

4

DI Record Publish Date

September 04, 2016

Package DI Number

20673978538420

Quantity per Package

12

Contains DI Package

00673978538426

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

PK