Catalog Number

-

Brand Name

Medical Action Industries

Version/Model Number

77345

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

OIE

Product Code Name

Urine collection kit (excludes HIV testing)

Public Device Record Key

c098d1a5-8125-4207-a195-575f85167b88

Public Version Date

April 23, 2018

Public Version Number

1

DI Record Publish Date

March 22, 2018

Package DI Number

20809160183479

Quantity per Package

50

Contains DI Package

10809160183472

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-