Catalog Number

895608

Brand Name

Bard® Pediatric Urine Meter Foley Tray with Bardex® Lubricath® Foley Catheter

Version/Model Number

895608

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

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

EZC

Product Code Name

CATHETER, COUDE

Public Device Record Key

979726e7-a7db-414d-8262-bda272c062ca

Public Version Date

December 04, 2020

Public Version Number

3

DI Record Publish Date

June 13, 2016

Package DI Number

10801741080675

Quantity per Package

10

Contains DI Package

00801741080678

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CA