Catalog Number

-

Brand Name

GLOBAL HEALTHCARE

Version/Model Number

UB-RC

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

7be036db-968f-4d59-92bb-5b559effc308

Public Version Date

January 08, 2021

Public Version Number

5

DI Record Publish Date

September 12, 2016

Package DI Number

40872237004278

Quantity per Package

50

Contains DI Package

00872237004270

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE