Catalog Number

-

Brand Name

ICU Medical

Version/Model Number

CH3003

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

K082836,K082836

Product Code

FMG

Product Code Name

Stopcock, i.V. Set

Public Device Record Key

fbb2db2c-29e1-4c7c-bd10-7fded9f1d295

Public Version Date

July 16, 2019

Public Version Number

1

DI Record Publish Date

July 08, 2019

Package DI Number

10840619023888

Quantity per Package

25

Contains DI Package

00840619023881

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-