Catalog Number

-

Brand Name

MEDICAL ACTION INDUSTRIES

Version/Model Number

71369

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

November 11, 2021

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

PEZ

Product Code Name

Central venous catheter dressing change kit

Public Device Record Key

6b17ce71-31ab-4999-b00e-e0b37bbf4fa3

Public Version Date

November 12, 2021

Public Version Number

5

DI Record Publish Date

August 23, 2016

Package DI Number

20809160000349

Quantity per Package

20

Contains DI Package

10809160000342

Package Discontinue Date

November 11, 2021

Package Status

Not in Commercial Distribution

Package Type

-