Catalog Number

-

Brand Name

ICU Medical

Version/Model Number

CH3198

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

K173477,K173477

Product Code

ONB

Product Code Name

Closed antineoplastic and hazardous drug reconstitution and transfer system

Public Device Record Key

7f07a567-ff84-4c5f-994c-2e6881d2f7c2

Public Version Date

February 19, 2021

Public Version Number

2

DI Record Publish Date

July 08, 2019

Package DI Number

10840619025431

Quantity per Package

50

Contains DI Package

00840619025434

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-