Catalog Number

-

Brand Name

Medex

Version/Model Number

MXG300273

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

K820355,K820355

Product Code

DRS

Product Code Name

TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR

Public Device Record Key

58d0d5d1-6c30-40a4-a0a9-4b6f604af152

Public Version Date

July 06, 2018

Public Version Number

4

DI Record Publish Date

March 16, 2017

Package DI Number

35019517090417

Quantity per Package

10

Contains DI Package

15019517090413

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX