Catalog Number

390000

Brand Name

RUSCH

Version/Model Number

IPN029795

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

fb774c0f-8ed1-4d4a-a1d2-2e3f51ca9b9a

Public Version Date

January 08, 2021

Public Version Number

4

DI Record Publish Date

June 20, 2019

Package DI Number

24026704666106

Quantity per Package

20

Contains DI Package

14026704666109

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box