Catalog Number

-

Brand Name

McKesson

Version/Model Number

4605

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

FAQ

Product Code Name

Bag, Urine Collection, Leg, For External Use, Sterile

Public Device Record Key

6ab29eea-de4f-4ae0-b2c0-218593949580

Public Version Date

April 07, 2021

Public Version Number

4

DI Record Publish Date

September 20, 2018

Package DI Number

00612479191273

Quantity per Package

48

Contains DI Package

00612479191266

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case