Catalog Number

802010

Brand Name

Bardia® Foley Catheter Insertion Tray

Version/Model Number

802010

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"

-

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

OHR

Product Code Name

Catheter care tray

Public Device Record Key

216eab3c-652d-473a-a9c0-66f6f49070eb

Public Version Date

December 04, 2020

Public Version Number

4

DI Record Publish Date

July 29, 2016

Package DI Number

10801741018289

Quantity per Package

20

Contains DI Package

00801741018282

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CA