Catalog Number

CL2000S-PC

Brand Name

ICU Medical

Version/Model Number

CL2000S-PC

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

K131549,K131549

Product Code

ONB

Product Code Name

Closed antineoplastic and hazardous drug reconstitution and transfer system

Public Device Record Key

fd6befab-8b02-45ed-ac61-9e9a9f649b0f

Public Version Date

September 06, 2021

Public Version Number

1

DI Record Publish Date

August 29, 2021

Package DI Number

10887709124025

Quantity per Package

50

Contains DI Package

00887709124028

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CS