Catalog Number

-

Brand Name

Medex

Version/Model Number

MX387

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

K883094,K883094

Product Code

FMF

Product Code Name

Syringe, piston

Public Device Record Key

d9190ca9-5cdd-434f-8b8b-7b1e42cea7b2

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

October 19, 2016

Package DI Number

50351688507929

Quantity per Package

20

Contains DI Package

10351688507921

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE