Catalog Number

-

Brand Name

Medical Action Industries

Version/Model Number

76827

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

OKH

Product Code Name

Body fluids barrier kit

Public Device Record Key

b919ec70-4fd0-4db5-a9cb-8a303a548ffb

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

April 21, 2017

Package DI Number

20809160145484

Quantity per Package

10

Contains DI Package

10809160145487

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-