Catalog Number

-

Brand Name

ICU Medical

Version/Model Number

Z7104

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

K081361,K081361

Product Code

FPA

Product Code Name

Set, administration, intravascular

Public Device Record Key

53591b65-c96e-4b77-b90b-a01b0578e0bb

Public Version Date

April 07, 2021

Public Version Number

7

DI Record Publish Date

November 07, 2017

Package DI Number

10887709035840

Quantity per Package

25

Contains DI Package

00887709035843

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-