Catalog Number

300016A

Brand Name

Bardex® I.C. Complete Care® Foley Tray

Version/Model Number

300016A

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)

Yes

Device labeled as "Not made with natural rubber latex"

-

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

MJC

Product Code Name

CATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES

Public Device Record Key

422c6436-a885-470d-8340-4d2afe9c3a69

Public Version Date

May 18, 2022

Public Version Number

4

DI Record Publish Date

July 23, 2016

Package DI Number

10801741000260

Quantity per Package

10

Contains DI Package

00801741000263

Package Discontinue Date

September 03, 2021

Package Status

Not in Commercial Distribution

Package Type

CA