Catalog Number

504040401

Brand Name

ICU Medical

Version/Model Number

50404-01

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

K091268,K091268

Product Code

DQE

Product Code Name

Catheter, oximeter, fiber-optic

Public Device Record Key

c7c147eb-7652-4dca-a3f3-cbd27ab7160a

Public Version Date

September 06, 2021

Public Version Number

1

DI Record Publish Date

August 29, 2021

Package DI Number

10840619045378

Quantity per Package

5

Contains DI Package

00840619045371

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CS