Catalog Number

-

Brand Name

ICU Medical

Version/Model Number

Z3249

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

K983559,K983559

Product Code

FJK

Product Code Name

SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE

Public Device Record Key

3b6891b9-114f-45de-bc00-a5f7d7ac0d75

Public Version Date

November 19, 2020

Public Version Number

6

DI Record Publish Date

October 31, 2017

Package DI Number

10887709030524

Quantity per Package

25

Contains DI Package

00887709030527

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-