Catalog Number

-

Brand Name

ICU Medical

Version/Model Number

B1473

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K052865,K052865

Product Code

DQO

Product Code Name

CATHETER, INTRAVASCULAR, DIAGNOSTIC

Public Device Record Key

eb5b27e8-220c-4161-ac96-9990bd202f4c

Public Version Date

January 23, 2019

Public Version Number

5

DI Record Publish Date

April 17, 2017

Package DI Number

10887709001869

Quantity per Package

50

Contains DI Package

00887709001862

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-