Urofoam®-1 Single-Sided Adhesive Foam Strip Box of 50

Basic Information

• Brand Name: Urofoam®-1 Single-Sided Adhesive Foam Strip Box of 50
• Primary DI: 00792293051004
• Version / Model: 5100
• Catalog Number: 5100
• 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: 4
• Public Version Date: 2022-11-09
• Public Version Status: Update
• Public Device Record Key: f15d6658-4655-49d0-b38d-88f54c43648f

Device Description

Urofoam®-1 single-sided adhesive foam strips are soft, pliable foam strips specifically designed for the unique application of male external catheters to the body and are suitable for use with both standard and self-adhering type catheters. They provide a comfortable, effective way to secure a male external catheter to the body. They are easy to apply and remove so when it comes time to change that catheter, it can be changed easily and quickly. It is recommended that a male external catheter be changed once a day to promote healthy skin, however, with the use or Urofoam® strips, a male external catheter can be held in place for up to three days—results may vary, but it's nice to know that when you need to depend on an adhesive strip, you can depend on Urofoam®.

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: Yes
• 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
KGX	Tape And Bandage, Adhesive	General Hospital	880.5240	1

GMDN Terms

Code	Name	Definition	Implantable	Status
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
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	00792293051004	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			0.09" x 0.88" x 5.75" (0.3cm x 2.2cm x 14.6cm)
Weight	0.18	Pound

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store in cool, dark, dry place.