Catalog Number

-

Brand Name

MEDICAL ACTION INDUSTRIES

Version/Model Number

79442

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

January 16, 2020

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

610ce8eb-5322-452c-8e2e-03a93128595c

Public Version Date

January 17, 2020

Public Version Number

2

DI Record Publish Date

May 24, 2019

Package DI Number

20809160240868

Quantity per Package

20

Contains DI Package

10809160240861

Package Discontinue Date

January 16, 2020

Package Status

Not in Commercial Distribution

Package Type

-