Catalog Number

CP3011Y

Brand Name

ChemoPlus

Version/Model Number

CP3011Y

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"

-

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

KPE

Product Code Name

CONTAINER, I.V.

Public Device Record Key

cc686eeb-aa30-494b-b25e-dfbef12beda8

Public Version Date

November 08, 2021

Public Version Number

8

DI Record Publish Date

September 24, 2016

Package DI Number

20884527006257

Quantity per Package

20000

Contains DI Package

10884527006250

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE