Catalog Number

-

Brand Name

Medex

Version/Model Number

MXG300128

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

DRS

Product Code Name

TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR

Public Device Record Key

9e6e7a17-e1cf-4b50-a726-295f9af07202

Public Version Date

June 11, 2018

Public Version Number

3

DI Record Publish Date

October 13, 2016

Package DI Number

50351688501224

Quantity per Package

10

Contains DI Package

10351688501226

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE