Catalog Number

CL3534U

Brand Name

ICU Medical

Version/Model Number

CL3534U

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

09805199-eab3-4df6-adbb-35f75c77123d

Public Version Date

October 17, 2022

Public Version Number

1

DI Record Publish Date

October 07, 2022

Package DI Number

10887709125756

Quantity per Package

50

Contains DI Package

00887709125759

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX