Catalog Number

150111

Brand Name

Bard® Leg Bag Holders

Version/Model Number

150111

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

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

cdc73baf-33ac-4e5d-9aab-544199a3fbe3

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

August 10, 2016

Package DI Number

10801741127622

Quantity per Package

12

Contains DI Package

00801741127625

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CA