Catalog Number

680002/A

Brand Name

Critikit™

Version/Model Number

10884450320911

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

d50cea5e-c4e7-4410-aa88-bf6271442cea

Public Version Date

December 13, 2021

Public Version Number

4

DI Record Publish Date

January 30, 2018

Package DI Number

20884450320918

Quantity per Package

10

Contains DI Package

10884450320911

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-