Duns Number:070637129
Device Description: BRUSH, CLEANING, APPLIANCE, URINARY, OSTOMY, SMALL PARTS, STAINLESS STEEL, NYLON BRISTLES, BRUSH, CLEANING, APPLIANCE, URINARY, OSTOMY, SMALL PARTS, STAINLESS STEEL, NYLON BRISTLES, 8" (20CM)This brush is made with durable, white-nylon bristles and a malleable, twisted, stainless-steel wire body. It may be shaped to fit almost any contour and is especially good for removing uric crystal build-ups from within urinary and ostomy appliances. May be used with Urocare® reusable Latex urinary leg bags, Urocare® Urinary Drainage Bottle, Urocare® Male Urinal Systems, Urocare® Male Urinal Kits or any other urinary or ostomy appliance that has small parts, tight corners, small holes and other hard to reach areas that need periodic brushing to loosen calcium and uric crystal build-ups.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!
Catalog Number
7003
Brand Name
Urocare® Urinary & Ostomy Appliance Cleaning Brush 8" (20cm)
Version/Model Number
7003
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
dedbe542-8ab6-4c34-be66-4b3b9e24fc36
Public Version Date
June 10, 2022
Public Version Number
7
DI Record Publish Date
June 01, 2018
Package DI Number
10792293070033
Quantity per Package
24
Contains DI Package
00792293070036
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 |