Catalog Number

011-MC33001

Brand Name

ICU Medical

Version/Model Number

011-MC33001

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

K100576,K100576

Product Code

FPA

Product Code Name

Set, administration, intravascular

Public Device Record Key

d981c05f-c397-4a4f-9705-dade59fd1082

Public Version Date

September 01, 2021

Public Version Number

1

DI Record Publish Date

August 24, 2021

Package DI Number

10840619057449

Quantity per Package

50

Contains DI Package

00840619057442

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CS