Catalog Number

720014

Brand Name

Bard® Foley Catheter Kit With Bardex® All-Silicone Foley Catheter

Version/Model Number

720014

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

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

GBM

Product Code Name

CATHETER, URETHRAL

Public Device Record Key

1a1bddd8-d23e-4007-ae26-0803f09224c0

Public Version Date

December 04, 2020

Public Version Number

3

DI Record Publish Date

August 16, 2016

Package DI Number

10801741040631

Quantity per Package

20

Contains DI Package

00801741040634

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CA