Catalog Number

-

Brand Name

MEDICAL ACTION INDUSTRIES

Version/Model Number

77635B

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

FCN

Product Code Name

Urinary drainage collection kit, for indwelling catheter

Public Device Record Key

02367ba0-eb3e-4061-b3f8-e52a1a6c7491

Public Version Date

July 26, 2018

Public Version Number

1

DI Record Publish Date

June 25, 2018

Package DI Number

20809160198909

Quantity per Package

20

Contains DI Package

10809160198902

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-