Duns Number:070637129
Device Description: CLEANSER, APPLIANCE, URINARY, OSTOMY, DEODORANT, ACID BASED, CITRUS SCENTED, TRIAL BOTTLE CLEANSER, APPLIANCE, URINARY, OSTOMY, DEODORANT, ACID BASED, CITRUS SCENTED, TRIAL BOTTLE 4 OZ. (188 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.
Catalog Number
700204
Brand Name
Urolux® Urinary and Ostomy Appliance Cleanser & Deodorant, Trial 4 oz. (118 mL.)
Version/Model Number
700204
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"
-
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
FAQ
Product Code Name
Bag, Urine Collection, Leg, For External Use, Sterile
Public Device Record Key
c3369a2f-72e2-4b51-aabc-7e3a57e9f43a
Public Version Date
June 10, 2022
Public Version Number
7
DI Record Publish Date
June 01, 2018
Package DI Number
10792293702040
Quantity per Package
24
Contains DI Package
00792293702043
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
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 |