Catalog Number

-

Brand Name

Manufacturing Kit CMExpress® Pump

Version/Model Number

100-500PXE

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

October 15, 2020

Issuing Agency

In HIBCC

MRI safety Status

MR Unsafe

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

-

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

-

Product Code

FRN

Product Code Name

Pump, Infusion

Public Device Record Key

b0d2018a-0cb5-48a8-9c6d-3f8488ee32bc

Public Version Date

July 04, 2022

Public Version Number

4

DI Record Publish Date

July 08, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-