Catalog Number

46114-35

Brand Name

ICU Medical

Version/Model Number

46114-35

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)

Yes

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

cb5e881a-31e4-40ee-9c4d-7b754c82e02a

Public Version Date

September 06, 2021

Public Version Number

1

DI Record Publish Date

August 29, 2021

Package DI Number

10887709076409

Quantity per Package

20

Contains DI Package

00887709076402

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CS