Catalog Number

-

Brand Name

CMExpress® Microbore Set

Version/Model Number

A120-160C

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

November 04, 2019

Issuing Agency

In HIBCC

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

K042696,K042696

Product Code

FPA

Product Code Name

Set, Administration, Intravascular

Public Device Record Key

f0073f82-4f1e-48b2-803e-34db77a7494b

Public Version Date

July 09, 2020

Public Version Number

4

DI Record Publish Date

August 22, 2016

Package DI Number

B101A120160C1

Quantity per Package

20

Contains DI Package

B101A120160C0

Package Discontinue Date

November 04, 2019

Package Status

Not in Commercial Distribution

Package Type

Case