Urolux® Urinary & Ostomy Appliance Cleanser/Deodorant, Standard 16 oz. (473 mL.) - CLEANSER, APPLIANCE, URINARY, OSTOMY, DEODORANT, - UROCARE PRODUCTS, INC.

Duns Number:070637129

Device Description: CLEANSER, APPLIANCE, URINARY, OSTOMY, DEODORANT, ACID BASED, CITRUS SCENTED, STANDARD BOTT CLEANSER, APPLIANCE, URINARY, OSTOMY, DEODORANT, ACID BASED, CITRUS SCENTED, STANDARD BOTTLE 16 OZ. (473 ML.)Rinsing alone does not clean a urinary or ostomy appliance and the use of vinegar, bleaches or toilet bowl cleaners only hardens, distorts and damages rubber, latex and plastic parts—not to mention the unpleasant and embarrassing odors often created by the use of these chemicals. Urocare® recommends the use of Urolux® urinary and ostomy appliance cleanser and deodorant for cleaning latex or rubber urinary leg bags, male urinal sheaths, urinary drainage bottles, urinary drainage and extension tubing or any other reusable urinary or ostomy appliance. Urolux® is a concentrated solution specifically formulated to clean and deodorize rubber, latex or plastic urinary and ostomy appliances. Crystal build-ups are dissolved and unpleasant odors are eliminated. Don't let corrosion happen to your urinary or ostomy appliance... Use Urolux!Features:• Effectively Cleans the Entire Fluid Pathway• Fresh Citrus Scent• Concentrated Formula Goes A Long Way• Dissolves Calcium and Urine Crystal Build-Ups• For use with Urinary & Ostomy AppliancesPRECAUTIONS: Urolux contains phosphoric acid which may cause burns to skin and eyes. Avoid contact with all materials other than glass, plastics, rubber and latex. Avoid contamination of food and contact with skin and eyes. Use only as directed. Keep out of reach of children.

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More Product Details

Catalog Number

700216

Brand Name

Urolux® Urinary & Ostomy Appliance Cleanser/Deodorant, Standard 16 oz. (473 mL.)

Version/Model Number

700216

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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"

-

For Single-Use

Yes

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 Details

Product Code

FAQ

Product Code Name

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

Device Record Status

Public Device Record Key

589ef5fc-2ba1-49e7-9122-0d9852a808ac

Public Version Date

June 10, 2022

Public Version Number

7

DI Record Publish Date

June 01, 2018

Additional Identifiers

Package DI Number

10792293702163

Quantity per Package

12

Contains DI Package

00792293702166

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case

"UROCARE PRODUCTS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 140
2 A medical device with a moderate to high risk that requires special controls. 6