Catalog Number

CH4001

Brand Name

ICU Medical

Version/Model Number

CH4001

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

K173477,K173477

Product Code

ONB

Product Code Name

Closed antineoplastic and hazardous drug reconstitution and transfer system

Public Device Record Key

da858fbd-f02a-4fdd-88b8-1b010f02fa54

Public Version Date

September 06, 2021

Public Version Number

1

DI Record Publish Date

August 29, 2021

Package DI Number

10840619056480

Quantity per Package

25

Contains DI Package

00840619056483

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CS