Catalog Number

-

Brand Name

MEDICAL ACTION INDUSTRIES

Version/Model Number

75630

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

November 12, 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

-

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

-

FDA Premarket Submission

-

Product Code

FCN

Product Code Name

Urinary drainage collection kit, for indwelling catheter

Public Device Record Key

157a68ab-eaa3-4f96-ab54-8fd1f97ce975

Public Version Date

November 15, 2021

Public Version Number

3

DI Record Publish Date

August 24, 2016

Package DI Number

20809160000677

Quantity per Package

50

Contains DI Package

10809160000670

Package Discontinue Date

November 12, 2021

Package Status

Not in Commercial Distribution

Package Type

-