Catalog Number

CMPSN007

Brand Name

Centurion

Version/Model Number

CMPSN007

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"

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

OEZ

Product Code Name

Cardiovascular procedure kit

Public Device Record Key

a82d08a6-7c77-4f5c-b0b6-fc0377afba1b

Public Version Date

September 23, 2019

Public Version Number

1

DI Record Publish Date

September 15, 2019

Package DI Number

00653160329551

Quantity per Package

50

Contains DI Package

10653160329558

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE