Catalog Number

153206

Brand Name

Bard® Pediatric Urine Meter

Version/Model Number

153206

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

58bb0db0-21d8-42a0-bbf1-9058a0368546

Public Version Date

April 08, 2022

Public Version Number

5

DI Record Publish Date

September 06, 2016

Package DI Number

10801741033121

Quantity per Package

10

Contains DI Package

00801741033124

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CA