Catalog Number

-

Brand Name

ICU Medical

Version/Model Number

B9622

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

39ab867a-2732-4269-b8e5-f06937a5ae97

Public Version Date

November 19, 2020

Public Version Number

7

DI Record Publish Date

July 10, 2017

Package DI Number

10887709014708

Quantity per Package

25

Contains DI Package

00887709014701

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-