Pathway

Basic Information

• Brand Name: Pathway
• Primary DI: 00852423006035
• Version / Model: PDUO
• Catalog Number: PDUO
• Company Name: PROMETHEUS GROUP OF NEW HAMPSHIRE LIMITED, THE
• Labeler DUNS: 625863568
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-26
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 4e1b0887-5b97-41ed-900b-31787b868229

Device Description

Pathway® DUO for Pediatric Voiding Dysfunction

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• 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
EXY	Uroflowmeter	Gastroenterology, Urology	876.1800	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47460	Urine monitoring system monitor	A battery-powered, portable device that automatically and continuously displays urine output data (urine flow/volume) received via a cable from a urine monitoring system's output sensor to provide optimal renal and fluid management information when this is essential to patient care. The monitor typically has controls to allow healthcare staff modify the system settings, electronically stores urine output data, and provides alarms to alert staff to potential problems. It is typically mounted near the patient [e.g., on the patient's bed or an intravenous (IV) pole]. The monitor interconnects with an intensive care unit (ICU) clinical information system.	No	Active
47461	Urine monitoring system sensor	An electronic device (e.g., an optical reader) that automatically and continuously measures a patient's urine output (urine flow/volume) in a urine monitoring system's collection container. The sensor subsequently transmits urine output data, via a cable, to the system's monitor for display and electronic storage. It may be mounted on the patient's bed or an intravenous (IV) pole, and may be designed to support the urine collection container.	No	Active
47458	Urine monitoring system	An assembly of devices intended to automatically and continuously monitor and display a patient's urine output (urine flow/volume). The system typically consists of a battery-powered, portable monitor with controls, digital display, alarms, and memory; an electronic (e.g., optical) urine output sensor; and a disposable urine collection container. The system is typically used in situations where fluid and renal management are critical to patient treatment and care [e.g., during diuresis monitoring in the intensive care unit (ICU)].	No	Active
36337	Urine flowmeter, reusable	A device that is used to measure the flow and volume of urine from a patient during the course of normal urination in order to identify micturation disturbances. The device is usually used by healthcare professionals who instruct the patient to empty their bladder into the measuring chamber of the device; some types may be designed to be used by laymen. This device may use mechanical, electrical, or a combination for the measuring techniques and provide digital measurements such as total voided volume, volume at maximum flow, maximum flow rate, mean flow rate, flow time, and time of maximum flow. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00852423006035	GS1

Customer Contacts

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