Catalog Number

-

Brand Name

Medex

Version/Model Number

MX848X2SC

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 07, 2020

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

13c718e0-6336-4b6e-ba59-d4de63bd1b75

Public Version Date

August 07, 2020

Public Version Number

6

DI Record Publish Date

October 13, 2016

Package DI Number

50351688504690

Quantity per Package

25

Contains DI Package

10351688504692

Package Discontinue Date

August 07, 2020

Package Status

Not in Commercial Distribution

Package Type

Case