Catalog Number

-

Brand Name

Medex

Version/Model Number

MX456R

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

FPK

Product Code Name

Tubing, fluid delivery

Public Device Record Key

d3a110f7-a620-4cf7-846a-9d55af0e21f2

Public Version Date

January 21, 2020

Public Version Number

1

DI Record Publish Date

January 13, 2020

Package DI Number

50351688507110

Quantity per Package

50

Contains DI Package

10351688507112

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case