Catalog Number

680000/A

Brand Name

Critikit™

Version/Model Number

10884450320904

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

-

Product Code

KRB

Product Code Name

PROBE, THERMODILUTION

Public Device Record Key

35057855-0f38-48af-9207-12a48c341746

Public Version Date

December 13, 2021

Public Version Number

4

DI Record Publish Date

January 30, 2018

Package DI Number

20884450320901

Quantity per Package

2

Contains DI Package

10884450320904

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-