Catalog Number

497521

Brand Name

Thermodilution Catheter

Version/Model Number

497521

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

November 02, 2017

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)

Yes

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

-

Product Code

DQO

Product Code Name

Catheter, Intravascular, Diagnostic

Public Device Record Key

1ece36a0-802f-4531-a70b-e5cbb3f4a9ac

Public Version Date

March 10, 2021

Public Version Number

4

DI Record Publish Date

September 21, 2016

Package DI Number

20886333214673

Quantity per Package

5

Contains DI Package

00886333214679

Package Discontinue Date

November 02, 2017

Package Status

Not in Commercial Distribution

Package Type

Box