Catalog Number

0165B18

Brand Name

Bard Vertus Foley Catheter

Version/Model Number

0165B18

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

EZL

Product Code Name

CATHETER, RETENTION TYPE, BALLOON

Public Device Record Key

5ee99d00-997e-4635-bbdd-b59ab7fcae15

Public Version Date

December 04, 2020

Public Version Number

3

DI Record Publish Date

October 21, 2019

Package DI Number

10801741099226

Quantity per Package

12

Contains DI Package

00801741099229

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CA