Catalog Number

-

Brand Name

GLOBAL HEALTHCARE

Version/Model Number

UB-LE600

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

c4b6fc0c-74be-4c8b-a10a-c5423cb1c3d2

Public Version Date

April 07, 2021

Public Version Number

6

DI Record Publish Date

September 12, 2016

Package DI Number

40872237004254

Quantity per Package

48

Contains DI Package

00872237004256

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE