Catalog Number

304100A

Brand Name

Bard® Add-A-Foley Urine Meter Foley Tray

Version/Model Number

304100A

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

May 17, 2022

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

KNX

Product Code Name

COLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER

Public Device Record Key

be0ab737-1d6f-4b96-8b99-a490841eed48

Public Version Date

May 18, 2022

Public Version Number

5

DI Record Publish Date

July 28, 2016

Package DI Number

10801741040594

Quantity per Package

10

Contains DI Package

00801741040597

Package Discontinue Date

September 03, 2021

Package Status

Not in Commercial Distribution

Package Type

CA