Catalog Number

-

Brand Name

Medex

Version/Model Number

MX52461

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

FPA

Product Code Name

Set, administration, intravascular

Public Device Record Key

b8ab5b17-36ee-4fca-a0d7-5661eb1235e5

Public Version Date

October 23, 2019

Public Version Number

3

DI Record Publish Date

January 19, 2017

Package DI Number

50351688506809

Quantity per Package

50

Contains DI Package

10351688506801

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE