Catalog Number

800096

Brand Name

Bard® Center Entry Foley Tray with Bardex® All Silicone Foley Catheter

Version/Model Number

800096

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

May 18, 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

EZL

Product Code Name

CATHETER, RETENTION TYPE, BALLOON

Public Device Record Key

41b4734a-9410-42f1-8140-793bc3665543

Public Version Date

May 19, 2022

Public Version Number

4

DI Record Publish Date

June 13, 2016

Package DI Number

10801741040280

Quantity per Package

10

Contains DI Package

00801741040283

Package Discontinue Date

January 28, 2022

Package Status

Not in Commercial Distribution

Package Type

CA