Catalog Number

802110

Brand Name

Bardia® Foley Catheter Insertion Tray

Version/Model Number

802110

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

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

ce1e7e94-a5a9-4708-b87b-bb8a4c6e3cbd

Public Version Date

December 04, 2020

Public Version Number

4

DI Record Publish Date

July 28, 2016

Package DI Number

10801741018265

Quantity per Package

20

Contains DI Package

00801741018268

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CA