Morpheus

DI: 00852423006004 · Model: MOR0118 · PROMETHEUS GROUP OF NEW HAMPSHIRE LIMITED, THE

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Product Codes

GMDN Terms

Identifiers

Pkg Device Count

Basic Information

Brand Name: Morpheus
Primary DI: 00852423006004
Version / Model: MOR0118
Catalog Number: MOR0118
Company Name: PROMETHEUS GROUP OF NEW HAMPSHIRE LIMITED, THE
Labeler DUNS: 625863568
Distribution Status: In Commercial Distribution
Device Count in Pkg: 1
Record Status: Published
Publish Date: 2016-09-26
Public Version: 6
Public Version Date: 2023-12-04
Public Version Status: Update
Public Device Record Key: 5c4d1e09-92ae-4c1b-ad4e-8f3657600843

Device Description

Morpheus® Control Module

Device Characteristics

Single Use: No
Prescription Use (Rx): Yes
Over the Counter (OTC): No
Kit: Yes
Combination Product: No
HCT/P: No
Contains NRL: No
Not Made with NRL: No
MRI Safety: Labeling does not contain MRI Safety Information
Direct Marking Exempt: No
PM Exempt: No
Has Serial Number: Yes
Has Lot/Batch Number: No
Has Manufacturing Date: Yes
Has Expiration Date: No
Has Donation ID: No

Sterilization

Is Sterile: No
Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	892.1570	2
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	892.1560	2
KPI	Stimulator, Electrical, Non-Implantable, For Incontinence	Gastroenterology, Urology	876.5320	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35953	Diagnostic imaging telemedicine system	An assembly of devices designed to electronically transmit digitized radiology images, e.g., magnetic resonance imaging (MRI), x-ray, nuclear medicine, ultrasound, endosocopy or CT, and consultative text to one or more remote sites (teleradiology). The information is typically transmitted through, e.g., public service transmission channels, phone lines or microwave relays. It is primarily distinguished from a picture archiving and communication system (PACS) by its storage capacity and intended use. PACS is a large storage system and file controller storing and retrieving thousands of images, whilst a teleradiology system typically has a storage capacity of fewer than 1, 000 images.	No	Active
40971	Ultrasound imaging system operator console	A device that is a component of a diagnostic ultrasound imaging system that functions as the primary control panel. It includes hardware and software that allows for image display, processing, analysis, archiving and retrieval. It typically includes the capabilities to be interfaced into a picture archiving and communication system (PACS), a local area network (LAN), a radiology information system (RIS) or a hospital information system (HIS). It contains the primary controls for the direct operation of the ultrasound system and is typically incorporated in the system design as is the case with mobile or portable ultrasound systems.	No	Active
57812	Radiology DICOM image processing application software	A software application intended to facilitate management, distribution, and/or viewing of radiological digital imaging and communications in medicine (DICOM) image data; it is not intended for pathological image interpretation (i.e., not intended to detect and localize suspected abnormalities). It may be intended to facilitate image management (e.g., viewing, communication, printing, recording/disc burning) and/or image quality manipulation and quantification (e.g., non-interpretive graphical overlays).	No	Active
14307	Urodynamic measurement system	An assembly of devices used for advanced diagnosis/study of the bladder. It is used to identify the cause of abnormal voiding, including incontinence and is useful for the diagnosis of, e.g., neurogenic bladder diseases, stress incontinence, urinary path obstruction or spastic sphincters. A diagnostic urodynamic evaluation consists of uroflowmetry (measurement of urinary flow rate), urethral pressure profilometry (measurement of urethral pressure), gas or water cystometry (measurement of bladder capacity and response), and electromyogram (EMG) recording (the measurement of sphincter and other muscle activity). Long-term recording may also be analysed.	No	Active