Catalog Number

-

Brand Name

ICU Medical

Version/Model Number

B9309

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

66c8365b-8557-4edd-bfd8-02b085a7cb0f

Public Version Date

November 19, 2020

Public Version Number

5

DI Record Publish Date

April 18, 2017

Package DI Number

10887709013442

Quantity per Package

25

Contains DI Package

00887709013445

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-