Catalog Number

CH-33C

Brand Name

ICU Medical

Version/Model Number

CH-33C

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

K970855,K970855

Product Code

FMG

Product Code Name

Stopcock, i.V. Set

Public Device Record Key

c8059344-45f3-424e-87cf-042da7fd86c5

Public Version Date

September 01, 2021

Public Version Number

1

DI Record Publish Date

August 24, 2021

Package DI Number

10840619081482

Quantity per Package

50

Contains DI Package

00840619081485

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BX