Uro-Cath® II Silicone Self-Adhering Male External Catheter, Medium/Small 28mm

Basic Information

• Brand Name: Uro-Cath® II Silicone Self-Adhering Male External Catheter, Medium/Small 28mm
• Primary DI: 00792293301284
• Version / Model: 530128
• Catalog Number: 530128
• Company Name: UROCARE PRODUCTS, INC.
• Labeler DUNS: 070637129
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-01-01
• Public Version: 1
• Public Version Date: 2025-01-09
• Public Version Status: New
• Public Device Record Key: 9776a1da-9886-41dd-9360-a0bdbcb2591e

Device Description

These male external catheters are commonly referred to as a “Self-Adhering” style because they are contain an adhesive on the inside of the sheath which adheres to the skin when the catheter sheath is unrolled. Each Uro-Cath® II catheter has a thin, silicon sheath section similar to a condom at one end—the part that is rolled over the head and shaft of the penis—and a heavier funnel-shaped, cup section at the other where urine is drained from into a bag or other collection device making them virtually “twist-proof” by their unique design. A retainer tray is provided to keep the catheters round shape while in storage. Uro-Cath® II catheters come in 24mm, 28mm, 31mm, 35mm and 40mm sizes to suit a variety of individual requirements. They are packaged individually in a window pouch allowing for quick, easy product identification without opening the pouch. The back side of the pouch contains detailed, illustrated, application instructions relative to the product purchased–no “cookie-cutter” or “one fits all” instructions for all products like some similar products have. Once removed from the packaging and the retainer tray is removed, each catheter may be secured by simply unrolling the sheath over the shaft of the penis and firmly grasping around the shaft to ensure a secure fit for maximum comfort and security. Contains: 1 Uro-Cath® II Male External Catheter, Illustrated, application instructions on back of pouch/package.

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: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
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

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00792293301284	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Outer Diameter	28	Millimeter
Device Size Text, specify			Small/Medium
Weight	0.015	Pound

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store in a cool, dry place away from direct sunlight