Catalog Number

CP3011O

Brand Name

ChemoPlus

Version/Model Number

CP3011O

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

ea7c8ab2-bd7e-45f4-a8a3-5603d1c665da

Public Version Date

November 08, 2021

Public Version Number

8

DI Record Publish Date

September 24, 2016

Package DI Number

20884527006226

Quantity per Package

20000

Contains DI Package

10884527006229

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE