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

Basic Information

• Brand Name: Urolux® Urinary & Ostomy Appliance Cleanser/Deodorant, Standard 16 oz. (473 mL.)
• Primary DI: 00792293702166
• Version / Model: 700216
• Catalog Number: 700216
• Company Name: UROCARE PRODUCTS, INC.
• Labeler DUNS: 070637129
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-06-01
• Public Version: 7
• Public Version Date: 2022-06-10
• Public Version Status: Update
• Public Device Record Key: 589ef5fc-2ba1-49e7-9122-0d9852a808ac

Device Description

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 Appliances PRECAUTIONS: 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.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: Yes
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FAQ	Bag, Urine Collection, Leg, For External Use, Sterile	Gastroenterology, Urology	876.5250	1
JCB	Detergent	Pathology	864.4010	1
MDZ	Cleaners, Medical Devices	General Hospital	880.6992	2
NNW	Bag, Urine Collection, Leg, For External Use, Non-Sterile	Gastroenterology, Urology	876.5250	1
NNX	Device, Incontinence, Urosheath Type, Non-Sterile	Gastroenterology, Urology	876.5250	1

GMDN Terms

Code	Name	Definition	Implantable	Status
34929	Urinary incontinence penis sheath/port, single-use	A device intended to be worn on or over the penis by an incontinent patient to channel urine from the penis, via a tube, into a collection bag. It consists of a penis-worn sheath (e.g., condom-catheter) or adhesive port (e.g., glans penis attachment), and may include a portion of tubing; the bag is not included. This device provides an alternative to inserting a catheter through the urethra, especially when difficulty is encountered in insertion or retention. It may be used to treat urinary incontinence or for non-ambulatory patients. This is a single-use device.	No	Active
40504	Hand-held urinal, reusable	A portable, hand-held container intended to be directly urinated into by a patient for excretory purposes; it may be specific to male or female patients, or unisex. It is typically in the form of a bottle with a handle, or a bag, or pouch; it may include a noninvasive funnel and tubing, and may have a drain with a stopper in it to facilitate emptying. It is not intended to be worn by the patient. This is a reusable device.	No	Active
58924	Open-ended wearable urine collection bag, non-sterile	A non-sterile flexible plastic pouch designed to connect to a urinary catheter, a urinary condom catheter, or a urostomy bag, and to be strapped to the leg of a patient to collect discharged urine; it is designed with an opening for urine drainage. Also known as a leg bag, it is worn on the body to facilitate patient mobility. This is a single-use device.	No	Obsolete
58921	Non-wearable adult urine collection bag, open-ended	A flexible plastic pouch designed to connect to a urinary catheter or a urinary condom catheter to collect discharged urine from an adult/adolescent patient; it is designed with an opening for urine drainage. The device is not directly attached to the patient. This is a single-use device.	No	Active
45376	Penis/scrotum wearable urinal	A non-sterile urine drainage device designed for men with incontinence and a retracted penis that includes a front piece (a shaped cone) intended to contain both the penis and the scrotum to form a leak-proof seal around the male genitals. It is typically held in place with groin and waist straps and has a connected collection bag that functions as the reservoir for the collection of the urine. This device provides an alternative to inserting a catheter or wearing incontinence pads. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10792293702163	GS1	Case	12	In Commercial Distribution
Primary	00792293702166	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Weight	1.30	Pound
Height	8.25	Inch
Outer Diameter	2.50	Inch
Device Size Text, specify			Standard
Total Volume	16	Fluid Ounce
Total Volume	473	Milliliter

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store in a cool place out of reach of children. Keep away from food. Flush bottle thoroughly with water before recycling. DO NOT REUSE EMPTY BOTTLE.