Catalog Number

661501

Brand Name

Bard® Urodynamic Pump Tubing Set

Version/Model Number

661501

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"

-

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

FEN

Product Code Name

DEVICE, CYSTOMETRIC, HYDRAULIC

Public Device Record Key

5d6ee761-25c3-4ea3-86d6-7e485c3abfba

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

July 28, 2016

Package DI Number

10801741045766

Quantity per Package

10

Contains DI Package

00801741045769

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CA