Catalog Number

802001

Brand Name

Bardia® Closed System Urinary Drainage Bag With Anti-Reflux Chamber

Version/Model Number

802001

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

-

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

-

FDA Premarket Submission

-

Product Code

KNX

Product Code Name

COLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER

Public Device Record Key

7c9b578b-d2c0-486d-92cd-1ecd3933a623

Public Version Date

December 04, 2020

Public Version Number

4

DI Record Publish Date

September 06, 2016

Package DI Number

10801741040747

Quantity per Package

20

Contains DI Package

00801741040740

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CA