Catalog Number

AM3016

Brand Name

ICU Medical

Version/Model Number

AM3016

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

K042182,K042182

Product Code

FPA

Product Code Name

Set, administration, intravascular

Public Device Record Key

ab01bc81-504f-4975-a2ed-b847dd2fddc7

Public Version Date

October 27, 2021

Public Version Number

1

DI Record Publish Date

October 19, 2021

Package DI Number

10887709087153

Quantity per Package

50

Contains DI Package

00887709087156

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CS