Catalog Number

-

Brand Name

Medical Action Industries

Version/Model Number

78753

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

2904aba3-1989-4622-b36a-4e6ced1531d8

Public Version Date

March 07, 2019

Public Version Number

1

DI Record Publish Date

February 04, 2019

Package DI Number

20809160225780

Quantity per Package

20

Contains DI Package

10809160225783

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-