Catalog Number

-

Brand Name

Centurion

Version/Model Number

CWHG001-5

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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"

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

DRS

Product Code Name

TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR

Public Device Record Key

9f02f26a-0f3b-4474-831b-70ff50dff710

Public Version Date

June 11, 2018

Public Version Number

3

DI Record Publish Date

March 30, 2017

Package DI Number

00653160306606

Quantity per Package

5

Contains DI Package

10653160306603

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE