Catalog Number

154003

Brand Name

Bard® Urinary Drainage Bag With Anti-Reflux Dome

Version/Model Number

154003

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

October 13, 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

KNX

Product Code Name

COLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER

Public Device Record Key

4a893505-013d-440f-a940-365c29fcfdbb

Public Version Date

November 16, 2021

Public Version Number

5

DI Record Publish Date

September 06, 2016

Package DI Number

10801741040778

Quantity per Package

20

Contains DI Package

00801741040771

Package Discontinue Date

October 13, 2021

Package Status

Not in Commercial Distribution

Package Type

CA