Catalog Number

-

Brand Name

Centurion

Version/Model Number

ECVC195

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)

Yes

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

Yes

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

-

FDA Premarket Submission

-

Product Code

OES

Product Code Name

Cardiac catheterization kit

Public Device Record Key

d99f242a-4c69-4934-90a0-61cb1c78e8e3

Public Version Date

February 05, 2021

Public Version Number

5

DI Record Publish Date

September 12, 2016

Package DI Number

10653160218845

Quantity per Package

5

Contains DI Package

00653160218848

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE