Urocare® Latex Leg Straps with Buttons (Set of 3)

DI: 00792293060068 · Model: 6006 · UROCARE PRODUCTS, INC.

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Product Codes

GMDN Terms

Identifiers

Pkg Device Count

Basic Information

Brand Name: Urocare® Latex Leg Straps with Buttons (Set of 3)
Primary DI: 00792293060068
Version / Model: 6006
Catalog Number: 6006
Company Name: UROCARE PRODUCTS, INC.
Labeler DUNS: 070637129
Distribution Status: In Commercial Distribution
Device Count in Pkg: 1
Record Status: Published
Publish Date: 2018-04-11
Public Version: 3
Public Version Date: 2018-07-06
Public Version Status: Update
Public Device Record Key: 6f434296-ba22-40f4-9a60-392d133a5b3a

Device Description

STRAP, URINE COLLECTION, LATEX, BUTTONS, REUSABLE, REPLACEMENT, SET OF 3 Replacement Latex Leg Straps for use with all Urocare Latex Urine Collection Leg Bags and Male Urinal Systems.

Device Characteristics

Single Use: No
Prescription Use (Rx): No
Over the Counter (OTC): Yes
Kit: No
Combination Product: No
HCT/P: No
Contains NRL: Yes
Not Made with NRL: No
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
FAQ	Bag, Urine Collection, Leg, For External Use, Sterile	Gastroenterology, Urology	876.5250	1
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

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
45376	Penis/scrotum wearable urinal	A non-sterile urine drainage device designed for men with incontinence and a retracted penis that includes a front piece (a shaped cone) intended to contain both the penis and the scrotum to form a leak-proof seal around the male genitals. It is typically held in place with groin and waist straps and has a connected collection bag that functions as the reservoir for the collection of the urine. This device provides an alternative to inserting a catheter or wearing incontinence pads. This is a reusable device.	No	Active