Uro-Prep® Protective Skin Barrier Wipes (Box of 50)

Basic Information

• Brand Name: Uro-Prep® Protective Skin Barrier Wipes (Box of 50)
• Primary DI: 00792293055002
• Version / Model: 5500
• Catalog Number: 5500
• 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: 2022-12-08
• Public Version Status: Update
• Public Device Record Key: 75567a13-2eae-435c-8c08-3ef721bfbe65

Device Description

PROTECTIVE, BARRIER, DRESSING, SKIN, PADS, WIPES, SACHETTE, URINE COLLECTION, OSTOMY, MALE EXTERNAL CATHETER, LATEX-FREE Uro-Prep® Protective Barrier has been specifically formulated to create a protective barrier between delicate, sensitive skin and aggressive adhesives. They can be used under all types of medical adhesives. Packaged in a small, convenient wipe, Uro-Prep® skin barrier wipes are the perfect solution to aid in the protection of delicate skin that has become sensitive to repeated use of medical adhesives; especially, those used to secure male external urinary catheters and urinary or ostomy appliances. Uro-Prep® protective skin barrier wipes are alcohol based which are easy to apply, safe, effective. It is recommended that a male external catheter be changed once a day to promote healthy skin and using Uro-Prep® protective skin barrier wipes before applying a male external catheter, urinary or ostomy appliance will help protect skin from any aggressive adhesives used with their application. Key Features: • Alcohol Based—Dries quickly for fast use. • Many Uses—Can be used under all types of medical adhesives • Convenient—Travel size pads are small and easy to use • Soap & Water Clean-Up—Just wash, rinse and dry • Suitable for Hospital, Long-Term Care and Home Use • Reduces Adhesive Removal Trauma • Environmentally Friendly—Does not contain ozone-depleting chloro-fluorocarbons • Convenient Packaging—Use only what you need so there's less waste Note: For external use only.

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: No
• 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
EXE	Protector, Ostomy	Gastroenterology, Urology	876.5900	1
KGX	Tape And Bandage, Adhesive	General Hospital	880.5240	1
NNX	Device, Incontinence, Urosheath Type, Non-Sterile	Gastroenterology, Urology	876.5250	1
EZR	Cement, Stomal Appliance, Ostomy	Gastroenterology, Urology	876.5900	1
KOX	Solvent, Adhesive Tape	General, Plastic Surgery	878.4730	1

GMDN Terms

Code	Name	Definition	Implantable	Status
46206	Dry skin moisture barrier dressing	A substance (e.g., cream, paste, ointment, gel, foam, or aerosol) intended to be applied to the skin/external mucosa (e.g., lips) to provide a protective moisture barrier to the external environment and/or to soften and sooth the skin. It is typically used for conditions such as dry, itchy, flaky, cracked, denuded, irritated or sun-damaged skin, cheilitis, and/or herpetic skin lesions. It may be intended for sensitive areas (e.g., areolar, perianal, lips, ears), dry skin and/or deep fissures (e.g., on the feet); it may include a disposable applicator. After application, this device cannot be reused.	No	Active
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
10035	Skin surface device adhesive	A substance (e.g., gel, aerosol) intended to adhere a medical device (e.g., dressing, ostomy device, aesthetic restoration prosthesis) to the skin surface; it is not intended for invasive/surgical use but may be intended for other non-patient contact uses. It may be used in the home or healthcare facility. After application, this device cannot be reused.	No	Active
60494	Patient medical adhesive remover	A liquid solvent intended for removal of medical adhesive/adhered devices (e.g., residual adhesive, adhesive tape, ostomy devices) from a patient’s skin. After application, this device cannot be reused.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00792293055002	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Weight	0.004	Pound
Height	2.25	Inch
Depth	0.1	Inch
Width	2.25	Inch