Urocare® Universal Fabric Leg Bag Straps with Velcro® Closue (Set of 2)

Basic Information

• Brand Name: Urocare® Universal Fabric Leg Bag Straps with Velcro® Closue (Set of 2)
• Primary DI: 00792293063908
• Version / Model: 6390
• Catalog Number: 6390
• 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: 7ca2fb52-e61f-4e4c-8f60-d1604373a740

Device Description

STRAP, LEG BAG, LATEX-FREE, VELCRO, UNIVERSAL, REUSABLE For use with most vinyl disposable or latex reusable leg bags. They are an economical alternative to the standard latex rubber straps packaged with most urine collection bags. An elastic/cotton & body construction allows the self-gripping fastener to attach itself along the length of the strap making it fully adjustable to individual requirements providing a safe, secure hold with a comfortable fit. A special blend of elastic and cotton makes them durable and allows them to be hand or machine washed. Set Contains: 2 Universal Leg straps and Illustrated Use and Care Instructions. * STRAPS NOT SOLD SEPARATELY ** BAGS MUST HAVE STRAP LOOPS/EYELETS FOR STRAPS TO PASS THROUGH

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
Package	10792293063905	GS1	Case	12	In Commercial Distribution
Primary	00792293063908	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Weight	0.06	Pound
Device Size Text, specify			Fits: 8" ~ 24" DIA. (20cm ~ 61cm Ø)
Device Size Text, specify			Universal, One size fits all Suitable for 44 fl. oz. (1,3 L) leg bags or smaller.