Catalog Number

-

Brand Name

Medex

Version/Model Number

MX962H181

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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

K163172,K163172

Product Code

DRS

Product Code Name

Transducer, blood-pressure, extravascular

Public Device Record Key

3af4e7e2-e35a-4d97-92c9-d102b7ba4d79

Public Version Date

December 24, 2018

Public Version Number

4

DI Record Publish Date

September 15, 2017

Package DI Number

35019517082146

Quantity per Package

10

Contains DI Package

15019517082142

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX