Urocare® Leg Bag Holder, Upper Medium

Basic Information

• Brand Name: Urocare® Leg Bag Holder, Upper Medium
• Primary DI: 00792293063830
• Version / Model: 6383
• Catalog Number: 6383
• Company Name: UROCARE PRODUCTS, INC.
• Labeler DUNS: 070637129
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-05-29
• Public Version: 2
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 9acae191-d295-4ffd-9e18-c7b9809db473

Device Description

HOLDER, LEG BAG, LATEX-FREE, VELCRO, REUSABLE, UPPER MEDIUM A simple and cost effective solution to a prevent contact between the leg bag and the skin. Reducing sweating while allowing the skin to breathe freely. Their unique construction provides a simple method for securing a urine collection bag to the leg without the use of leg straps which are often the cause of circulation restriction in some individuals.

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
KNX	Collector, Urine, (And Accessories) For Indwelling Catheter	Gastroenterology, Urology	876.5250	2
NNW	Bag, Urine Collection, Leg, For External Use, Non-Sterile	Gastroenterology, Urology	876.5250	1
FAQ	Bag, Urine Collection, Leg, For External Use, Sterile	Gastroenterology, Urology	876.5250	1

GMDN Terms

Code	Name	Definition	Implantable	Status
58924	Open-ended wearable urine collection bag, non-sterile	A non-sterile flexible plastic pouch designed to connect to a urinary catheter, a urinary condom catheter, or a urostomy bag, and to be strapped to the leg of a patient to collect discharged urine; it is designed with an opening for urine drainage. Also known as a leg bag, it is worn on the body to facilitate patient mobility. This is a single-use device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00792293063830	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Weight	0.18	Pound
Device Size Text, specify			Upper Thigh: 22.75" DIA. (57.7cm Ø) Lower Thigh: 18.75" DIA. (46.7cm Ø)
Device Size Text, specify			Can hold up to a 26 fl. oz. (800 mL.) leg bag