Catalog Number

504050401

Brand Name

ICU Medical

Version/Model Number

50405-01

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

598387d6-c8f5-48d5-b6b4-1258665c4d0f

Public Version Date

September 06, 2021

Public Version Number

1

DI Record Publish Date

August 29, 2021

Package DI Number

10840619046597

Quantity per Package

5

Contains DI Package

00840619046590

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CS