Catalog Number

423770401

Brand Name

ICU Medical

Version/Model Number

42377-01

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

-

Product Code

DQO

Product Code Name

Catheter, intravascular, diagnostic

Public Device Record Key

2c103c73-af32-4f59-8227-d01f03a2ebc0

Public Version Date

September 06, 2021

Public Version Number

1

DI Record Publish Date

August 29, 2021

Package DI Number

10840619044418

Quantity per Package

25

Contains DI Package

00840619044411

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CS