Pathway® 6340

GUDID 00852423006189

Pathway® 6340 Rectal EMG/Stimulation Sensor

PROMETHEUS GROUP OF NEW HAMPSHIRE LIMITED, THE

Urodynamic measurement system

• Primary Device ID: 00852423006189
• NIH Device Record Key: b523e5d1-fd2f-4717-963a-195478c7458b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pathway®
• Version Model Number: 6340
• Catalog Number: 6340
• Company DUNS: 625863568
• Company Name: PROMETHEUS GROUP OF NEW HAMPSHIRE LIMITED, THE
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• 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
• Phone: 1.800.442.2325
• Email: info@theprogrp.com
• Phone: 1.800.442.2325
• Email: info@theprogrp.com
• Phone: 1.800.442.2325
• Email: info@theprogrp.com
• Phone: 1.800.442.2325
• Email: info@theprogrp.com
• Phone: 1.800.442.2325
• Email: info@theprogrp.com
• Phone: 1.800.442.2325
• Email: info@theprogrp.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00852423006189 [Primary]

FDA Product Code

• KPI: Stimulator, Electrical, Non-Implantable, For Incontinence

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-06-20
• Device Publish Date: 2016-09-26

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• 00852423006370: 5-10 MHz Linear Ultrasound Imaging - Rehabilitative Ultrasound Imaging
• 00852423006196: Pathway® Rectal Silicon Pressure Sensor
• 00852423006189: Pathway® 6340 Rectal EMG/Stimulation Sensor
• 00852423006172: Pathway® 6330 Vaginal EMG/Stimulation Sensor
• 00852423006165: Pathway® STM-10
• 00852423006141: Pathway® TR-20 Dual Channel EMG Trainer