N/A 5328

GUDID 00852423006219

24” Electrode Lead Wire Set

PROMETHEUS GROUP OF NEW HAMPSHIRE LIMITED, THE

Biofeedback system

• Primary Device ID: 00852423006219
• NIH Device Record Key: ff0bd912-2309-4a79-8948-3acd0d084639
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: N/A
• Version Model Number: 5328
• Catalog Number: 5328
• 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: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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	00852423006219 [Primary]

FDA Product Code

• HCC: Device, Biofeedback

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 [N/A]

• 00852423006363: 3.5-7.5 MHz Curvilinear Ultrasound Imaging_____ Doctor: Transperineal Ultrasound Imagin
• 00852423006301: Uroflowmetry Load Cell
• 00852423006240: Adapter for 7400 Disposable Lead Wire Electrodes
• 00852423006226: 6’ Electrode Lead Wire Set
• 00852423006219: 24” Electrode Lead Wire Set