Catalog Number

-

Brand Name

Medex

Version/Model Number

MX801

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

K790407,K790407

Product Code

FPB

Product Code Name

Filter, infusion line

Public Device Record Key

d07eb296-bb0c-4a39-9a94-aac2472f8ab5

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

October 13, 2016

Package DI Number

50351688505031

Quantity per Package

50

Contains DI Package

10351688505033

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE