Catalog Number

-

Brand Name

ICU Medical

Version/Model Number

CL-80S-10

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

K131549,K131549

Product Code

ONB

Product Code Name

Closed antineoplastic and hazardous drug reconstitution and transfer system

Public Device Record Key

5135eec4-269b-416b-b2b8-c3bf87090364

Public Version Date

April 07, 2021

Public Version Number

8

DI Record Publish Date

July 10, 2017

Package DI Number

10840619080577

Quantity per Package

25

Contains DI Package

00840619080570

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-