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A mains electricity-powered (AC-powered) component of a microwave ablation/electrosurgical system intended to generate both: 1) radio-frequency (RF) electrical current; and 2) microwave energy for subsequent cutting, coagulation, and ablation of soft tissues during an endoscopic or open surgical procedure; it is not dedicated to focal ablation of specific tissues. It includes controls, may include an integrated surgical plume (smoke) suction unit, and is intended to be connected via a cable to an electrosurgical handpiece and electrode (neither of these are included); it is not intended for argon-enhanced electrosurgery.
CREO MEDICAL LIMITED
Generator 7-EMR-050
Not in Commercial Distribution
- 05060359560087 ()
- Microwave/electrosurgical system generator
A non-patient-contact, insulated, electrical cord with a connector (plug) at both ends designed to transmit electrical power and/or signal (data) between medical devices (e.g., to connect a lead, electrical catheter, handpiece, or monitor to a parent device). It is not intended to connect directly to patient-worn electrodes (i.e., it is not a lead), is not intended to connect to the mains (i.e., not a mains power cable), does not generate any type of power and/or signal, and has no additional non-electrical conducting or processing functionality. Some types may include an electrical isolator to prevent electrical shocks, and/or a cable cover. This is a single-use device.
CREO MEDICAL LIMITED
Interface Cable
In Commercial Distribution
- 05060359560070 ()
7-RS2-210
- Electrical-only medical device connection cable, single-use
A non-patient-contact, insulated, electrical cord with a connector (plug) at both ends designed to transmit electrical power and/or signal (data) between medical devices (e.g., to connect a lead, electrical catheter, handpiece, or monitor to a parent device). It is not intended to connect directly to patient-worn electrodes (i.e., it is not a lead), is not intended to connect to the mains (i.e., not a mains power cable), does not generate any type of power and/or signal, and has no additional non-electrical conducting or processing functionality. Some types may include an electrical isolator to prevent electrical shocks, and/or a cable cover. This is a single-use device.
CREO MEDICAL LIMITED
7-RS2-210
In Commercial Distribution
- 05060359560063 ()
- Electrical-only medical device connection cable, single-use
MON 2490C15 CL 60601 3 ED HCM USA RFB
MEDTRONIC, INC.
2490C15
Not in Commercial Distribution
- 00643169341050 ()
- Cardiac pulse generator reader, home-use
An electronic device designed to calculate nasal resistance by measuring nasal airflow and the air pressure producing that flow within a patient's nasal passages, e.g., for the calculation of the nasal patency during ear/nose/throat (ENT) assessment/treatment. It is used to quantify the amount of nasal obstruction/congestion and is a computer-based device with dedicated software for data calculation, presentation (display), and storage purposes. This device will be powered via a connected computer and include or interface with a printer for hard copies of the graphical data presentation.
GM INSTRUMENTS LIMITED
NR6
In Commercial Distribution
- 05060485270034 ()
N/A
- Computerized rhinomanometer
A line powered (AC- powered), or powered via a connected computer, electronic device designed to allow the internal profile of the nose to be recorded in order to quantify the degree of obstruction/congestion in the nasal cavities and provide monitoring of the consequences of therapy or surgery.
A nosepiece conducts a sound pulse produced by an integrated sound generator to the patient's nose and the sound reflections from the nose are detected where changes in cross-sectional areas are encountered. It is a computer-based device with dedicated software for processing the output and return signals to produce plots of cross-sectional areas as a function of distance in the nose.
GM INSTRUMENTS LIMITED
A1
In Commercial Distribution
- 05060485270027 ()
N/A
- Acoustic rhinometer
Phagenyx Dysphagia Treatment Device
PHAGENESIS LIMITED
EPSB3
In Commercial Distribution
- 05060453480045 ()
EPSB3
- Pharyngeal electrical stimulation control unit
AIRFIT P10 FOR HER ADJUSTABLE HG
RESMED PTY LTD
62936
In Commercial Distribution
- 00619498629367 ()
62936
- CPAP/BPAP nasal mask, reusable
AIRFIT P10 ADJUSTABLE HEADGEAR
RESMED PTY LTD
62935
In Commercial Distribution
- 00619498629350 ()
62935
- CPAP/BPAP nasal mask, reusable
AIR 11 PSU 65W USA
RESMED PTY LTD
39205
In Commercial Distribution
- 00619498392056 ()
39205
- Home CPAP unit