Catalog Number

21-000009-41

Brand Name

Thermodilution Catheter and Accessories

Version/Model Number

TD2604NX (BNS)-CMS USA

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 01, 2020

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

-

Product Code

DQO

Product Code Name

Catheter, Intravascular, Diagnostic

Public Device Record Key

edd6791f-8497-433c-97c4-0eb1481cabe8

Public Version Date

March 10, 2021

Public Version Number

7

DI Record Publish Date

August 24, 2016

Package DI Number

98888893204751

Quantity per Package

9

Contains DI Package

08888893204758

Package Discontinue Date

December 01, 2020

Package Status

Not in Commercial Distribution

Package Type

CTN