Catalog Number

-

Brand Name

Medex

Version/Model Number

MX708

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

LHI

Product Code Name

Set, i.V. Fluid transfer

Public Device Record Key

c7ad7799-5e57-40ca-b88e-50f9095064f1

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

December 29, 2016

Package DI Number

50351688505611

Quantity per Package

25

Contains DI Package

10351688505613

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE