Catalog Number

-

Brand Name

Medex

Version/Model Number

MX401H212

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Conditional

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

K172458,K172458

Product Code

DRS

Product Code Name

Transducer, blood-pressure, extravascular

Public Device Record Key

7f39d58d-bfff-43f8-ad86-f42d284b3285

Public Version Date

February 08, 2019

Public Version Number

1

DI Record Publish Date

January 08, 2019

Package DI Number

35019517162633

Quantity per Package

10

Contains DI Package

15019517162639

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box