Catalog Number

-

Brand Name

Medex

Version/Model Number

M20178R2

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

347b797f-b864-40e2-8b53-f8f59255cce5

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

October 11, 2016

Package DI Number

50351688510783

Quantity per Package

10

Contains DI Package

10351688510785

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE