Pathway PDUO

GUDID 00852423006035

Pathway® DUO for Pediatric Voiding Dysfunction

PROMETHEUS GROUP OF NEW HAMPSHIRE LIMITED, THE

Urine monitoring system monitor

• Primary Device ID: 00852423006035
• NIH Device Record Key: 4e1b0887-5b97-41ed-900b-31787b868229
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pathway
• Version Model Number: PDUO
• Catalog Number: PDUO
• Company DUNS: 625863568
• Company Name: PROMETHEUS GROUP OF NEW HAMPSHIRE LIMITED, THE
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1.800.442.2325
• Email: info@theprogrp.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00852423006035 [Primary]

FDA Product Code

• EXY: Uroflowmeter

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-09-26

On-Brand Devices [Pathway]

• 00852423006332: Pathway® RealTime Ultrasound
• 00852423006233: Pathway® Adapter
• 00852423006202: Pathway® 6320 Vaginal/Rectal EMG Sensor
• 00852423006158: Pathway® TR-20C Dual Channel EMG Trainer
• 00852423006134: Pathway® TR-10C Single Channel EMG Trainer
• 00852423006127: Pathway® TR-10 Single Channel EMG Trainer
• 00852423006110: Pathway® NMR 400 Quad Channel EMG System
• 00852423006073: Pathway® MR-10 Single Channel EMG
• 00852423006066: Pathway® MR-15 Single Channel EMG
• 00852423006059: Pathway® MR-20 Dual Channel EMG
• 00852423006042: Pathway® MR-25 Dual Channel EMG
• 00852423006035: Pathway® DUO for Pediatric Voiding Dysfunction
• 00852423006028: Pathway® CTS 1500
• 00852423006011: Pathway® CTS 2000