Catalog Number

-

Brand Name

CMExpress® Microbore Set with Needleless Y-Site

Version/Model Number

A120-161CYF

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

October 15, 2020

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

-

Product Code

FPA

Product Code Name

Set, Administration, Intravascular

Public Device Record Key

4196bbf7-e891-4538-91aa-015428dce55f

Public Version Date

November 16, 2020

Public Version Number

2

DI Record Publish Date

July 08, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-