DEVICE: Pathway (00852423006035)
Device Identifier (DI) Information
Pathway
PDUO
In Commercial Distribution
PDUO
PROMETHEUS GROUP OF NEW HAMPSHIRE LIMITED, THE
PDUO
In Commercial Distribution
PDUO
PROMETHEUS GROUP OF NEW HAMPSHIRE LIMITED, THE
Pathway® DUO for Pediatric Voiding Dysfunction
Device Characteristics
Labeling does not contain MRI Safety Information | |
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No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
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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.
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Active | false |
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.
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Active | false |
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)].
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Active | false |
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.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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EXY | Uroflowmeter |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
4e1b0887-5b97-41ed-900b-31787b868229
March 29, 2018
2
September 26, 2016
March 29, 2018
2
September 26, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
1.800.442.2325
info@theprogrp.com
info@theprogrp.com