Catalog Number

150107

Brand Name

Bardia Leg Bag

Version/Model Number

150107

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)

Yes

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

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

a5542cd0-d3a8-45dc-b430-c9fefd00db77

Public Version Date

April 07, 2021

Public Version Number

3

DI Record Publish Date

September 22, 2020

Package DI Number

20801741050750

Quantity per Package

4

Contains DI Package

10801741050753

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CA