Catalog Number

-

Brand Name

ICU Medical

Version/Model Number

CH2000S

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

-

Product Code

ONB

Product Code Name

Closed antineoplastic and hazardous drug reconstitution and transfer system

Public Device Record Key

81750a08-f9fc-417f-b878-8258c9290a1f

Public Version Date

February 19, 2021

Public Version Number

2

DI Record Publish Date

July 08, 2019

Package DI Number

10840619033900

Quantity per Package

100

Contains DI Package

00840619033903

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-