Catalog Number

15687-28

Brand Name

ICU Medical

Version/Model Number

15687-28

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"

-

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

K141789,K141789

Product Code

FPA

Product Code Name

Set, administration, intravascular

Public Device Record Key

da335eea-b6bd-4f7d-8c93-5b5380fc5661

Public Version Date

September 21, 2022

Public Version Number

1

DI Record Publish Date

September 13, 2022

Package DI Number

10887709102467

Quantity per Package

48

Contains DI Package

00887709102460

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case