Uro-Con® Texas-Style Male External Catheter, Medium 30mm 4" Tube with Urofoam®-2

Basic Information

• Brand Name: Uro-Con® Texas-Style Male External Catheter, Medium 30mm 4" Tube with Urofoam®-2
• Primary DI: 00792293124302
• Version / Model: 512430
• Catalog Number: 512430
• Company Name: UROCARE PRODUCTS, INC.
• Labeler DUNS: 070637129
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-05-30
• Public Version: 2
• Public Version Date: 2022-06-10
• Public Version Status: Update
• Public Device Record Key: cd63834a-2b99-464d-988f-998349858d2c

Device Description

These male external catheters are commonly referred to as a “Texas-Style” because they employ a three-piece construction technique. Each Uro-Con® catheter has a thin, latex sheath similar to a condom—which is rolled over the head and shaft of the penis—and is attached to a 4"(10cm) or 2"(5cm) white-rubber tube—where urine is drained from into a bag or other collection device—by an plastic catheter insert. Using a “Condom” type sheath makes these catheters “fully collapsible” to prevent pooled urine a major cause of skin irritation and break-down. Uro-Con® catheters range in size from 25mm, our smallest, to 35mm, our largest in 5mm increments 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 Contains: 1 Uro-Con® Male External Catheter, 1 Urofoam®-2 Double-Sided Adhesive Foam Strip, 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: Yes
• 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
Package	10792293124309	GS1	Case	50	In Commercial Distribution
Primary	00792293124302	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Length	4	Inch
Device Size Text, specify			Foam Strip: 0.09" x 1" x 5.75" (0.3cm x 2.54cm x 14.6cm)
Outer Diameter	30	Millimeter
Device Size Text, specify			Medium
Weight	0.023	Pound