Catalog Number

-

Brand Name

MEDICAL ACTION INDUSTRIES

Version/Model Number

78431

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

Yes

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

PEV

Product Code Name

Dialysis administration kit

Public Device Record Key

c86fb459-0043-405a-8a77-42db2e362bb0

Public Version Date

January 23, 2019

Public Version Number

2

DI Record Publish Date

July 05, 2018

Package DI Number

20809160199586

Quantity per Package

20

Contains DI Package

10809160199589

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-