Catalog Number

-

Brand Name

Medex

Version/Model Number

MX821S

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

K790314,K790314

Product Code

FPB

Product Code Name

Filter, infusion line

Public Device Record Key

dd4cd11a-2371-427f-a956-6e221caaf66b

Public Version Date

September 16, 2022

Public Version Number

4

DI Record Publish Date

October 13, 2016

Package DI Number

50351688504911

Quantity per Package

25

Contains DI Package

10351688504913

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE