Catalog Number

-

Brand Name

Medex

Version/Model Number

MX4342LM

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

FMG

Product Code Name

Stopcock, i.V. Set

Public Device Record Key

380506fd-8d20-4a88-b03c-954f68adc975

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

December 30, 2016

Package DI Number

50351688507639

Quantity per Package

25

Contains DI Package

10351688507631

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE