Primus 9275

GUDID 00852423006097

Primus® Software for the Pathway® MR Series

PROMETHEUS GROUP OF NEW HAMPSHIRE LIMITED, THE

Biofeedback system

• Primary Device ID: 00852423006097
• NIH Device Record Key: 4eb1bd44-9a86-4f55-aa02-6d9c9a7f62a5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Primus
• Version Model Number: 9275
• Catalog Number: 9275
• 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: false
• 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
• 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	00852423006097 [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

Devices Manufactured by PROMETHEUS GROUP OF NEW HAMPSHIRE LIMITED, THE

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• 00852423006486 - EMYO®: 2021-09-08 EMYO®100S is a Single Channel EMG System for dysphagia rehabilitation
• 00852423006462 - Morpheus®: 2021-07-30 Morpheus® Transperineal Ultrasound Imaging
• 00852423006448 - EMYO®: 2020-07-01 EMYO®200 is a Dual Channel EMG System for Adult and Pediatric Pelvic Floor Rehabilitation
• 00852423006455 - EMYO®: 2020-07-01 EMYO®100 is a Single Channel EMG System for Adult and Pediatric Pelvic Floor Rehabilitation
• 00852423006431 - TELESIS®: 2019-10-11 9250-ST Telesis® ST Software for Speech Therapy MR Series
• 00852423006004 - Morpheus: 2019-10-07 Morpheus® Control Module
• 00852423006011 - Pathway: 2018-12-24 Pathway® CTS 2000