Catalog Number

CH3397

Brand Name

ICU Medical

Version/Model Number

CH3397

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"

Yes

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

K081361,K081361

Product Code

FPA

Product Code Name

Set, administration, intravascular

Public Device Record Key

a7eb7062-0488-46de-9ee4-c4fd3214575b

Public Version Date

August 04, 2021

Public Version Number

1

DI Record Publish Date

July 27, 2021

Package DI Number

10840619073678

Quantity per Package

50

Contains DI Package

00840619073671

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CS