Catalog Number

-

Brand Name

Medex

Version/Model Number

MX20462

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

-

Product Code

DPT

Product Code Name

PROBE, BLOOD-FLOW, EXTRAVASCULAR

Public Device Record Key

51fbb814-f368-4769-943c-543afc53da63

Public Version Date

June 11, 2018

Public Version Number

3

DI Record Publish Date

October 11, 2016

Package DI Number

50351688509459

Quantity per Package

10

Contains DI Package

10351688509451

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE