Catalog Number

-

Brand Name

Medical Action Industries

Version/Model Number

77635

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 26, 2018

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

6d6119f7-2008-414f-885e-3ef296049295

Public Version Date

April 27, 2018

Public Version Number

2

DI Record Publish Date

March 13, 2018

Package DI Number

20809160182274

Quantity per Package

20

Contains DI Package

10809160182277

Package Discontinue Date

April 26, 2018

Package Status

Not in Commercial Distribution

Package Type

-