Urocare® Fabric Foley® Catheter/Tubing Strap Abdominal 34"

Basic Information

• Brand Name: Urocare® Fabric Foley® Catheter/Tubing Strap Abdominal 34"
• Primary DI: 00792293063137
• Version / Model: 6313
• Catalog Number: 6313
• 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: 8
• Public Version Date: 2020-12-04
• Public Version Status: Update
• Public Device Record Key: ca71d6d6-9387-4cc3-bc5b-7ffef3f406f9

Device Description

STRAP, FABRIC, FOLEY, CATHETER, LATEX-FREE, VELCRO FASTENERS, REUSABLE There is an easier way to keep things in their place... Find out how easy it can be to attach your Foley® catheter or tubing with this elastic fabric strap. It's unique design distributes pressure evenly along the length of the strap offering a vast improvement in comfort while reducing the risk of bruising, pressure sores, pulled hair, circulation restriction and/or burns. The self-gripping fastener can engage anywhere along the length of the strap body making the strap fully adjustable to individual requirements. The durable material is hand or machine washable and the strap is available in multiple sizes Contains: 1 Fabric Catheter Strap, Use and Care Instructions

Device Characteristics

• Single Use: No
• 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: No
• 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
KNX	Collector, Urine, (And Accessories) For Indwelling Catheter	Gastroenterology, Urology	876.5250	2

GMDN Terms

Code	Name	Definition	Implantable	Status
34917	Indwelling urethral drainage balloon catheter, non-antimicrobial	A flexible tube with an inflatable balloon at its distal tip intended to be inserted through the urethra and retained in the urinary bladder, or prostatic bed, of an adult or paediatric patient to function as an indwelling therapeutic device for urinary drainage; it might also be designed for infusion of fluids (irrigation). It may have a bent tip (coude) to facilitate insertion, and some types may be provided with a guidewire to facilitate difficult insertion (e.g., in cases of enlarged prostate); it does not include an antimicrobial agent(s). Most types are commonly known as a Foley catheter; it is intended to be introduced by a healthcare professional. This is a single-use device.	No	Active
57982	Urinary catheter holder	A device designed to be attached to a patient's body to hold an indwelling urinary catheter line (e.g., Foley) in place. It consists of a wrap or adhesive strip/pad placed around the patient's thigh, abdomen, or pubis. The holder includes appropriate mechanisms or attachments that can hold the tube or catheter (e.g., integrated Velcro hook, loop, clip) without creating excessive pressure on it and permitting visual inspection of the site. It is not designed to hold a urine collection bag. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00792293063137	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Overall Length: 34" (86cm), Fits: 17" ~ 58" DIA. (43cm x 147cm Ø)
Weight	0.10	Pound