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The Millennia Software system is indicated for: Cardiac evaluation of heart rate and rhythm in patients experiencing syncope, near syncope, dizziness, palpitations, shortness of breath, chest pain and transient arrhythmia.
To assess risk for future cardiac events in patients without symptoms from arrhythmia who have been diagnosed with congestive heart failure, idiopathic hypertrophic cardiomyopathy, and post myocardial infarction with left ventricular dysfunction.
Assessment of drug response in patients taking antiarrhythmic medications. Baseline frequency of the arrhythmia should be characterized as reproducible and of sufficient frequency to permit evaluation.
ST segment analysis in patients with known coronary heart disease, chest pain, and suspected variant angina.
BRAEMAR MANUFACTURING, LLC
900-0618-00
In Commercial Distribution
- B146C1MA001010 ()
- Electrocardiographic long-term ambulatory recording analyser application software
Actical Software Global
Respironics, Inc.
3.11
In Commercial Distribution
- 00606959021013 ()
1081738
- Kinesiology ambulatory recorder
No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
11149925
Not in Commercial Distribution
- 04056869006833 ()
- Radiological PACS software
No Description
OTODYNAMICS LIMITED
ILOv6
In Commercial Distribution
- 05060396170713 ()
- Otoacoustic emission system, line-powered
No Description
OTODYNAMICS LIMITED
EZ-Screen
In Commercial Distribution
- 05060396170706 ()
- Otoacoustic emission system, line-powered
The WAW Duo FUE System is intended for Follicular Unit Extraction (FUE) with the aim to harvest hair follicles
by preserving hair integrity (amount of hair per follicle and hair quality) for further hair graft implantation. This
is done by optimizing hair transplant for both the receiver (increasing quality of the recipient area with respect
to naturalness and density) and the donor (taking care of the donor region).
The WAW Duo FUE System is composed of the following:
- The WAW Wireless Handpiece:
o Composed of a motor and a battery, and a detachable cleanable (via autoclave) external
sleeve
o Connected via Bluetooth to the tablet
o Responsible for the rotation and oscillation movements of the punch (not included) for the
FUE,
- The WAW Wired Handpiece, a backup solution for the WAW Wireless Handpiece:
o Cleanable (via autoclave)
o Connected via a wire to the pedal
o Responsible for the rotation and oscillation movements of the punch for the FUE,
- The WAW Pedal, responsible for activating the handpieces,
- The WAW Software, responsible for defining the parameters of functioning (rotation and
oscillation movement) of the handpieces and mode (manual, semi-auto, auto or continuous) of the
pedal (the Samsung tablet is supplied),
- The WAW Charging Station, intended to recharge the wireless handpiece and
- The External Sleeve Support Box, intended to sustain external parts of WAW Wireless
Handpiece and WAW Wired Handpiece during autoclave process.
- Assembly tools: 3 mounting tools to assemble and disassemble the handpieces.
Devroye Instruments Belgium
0.1.35
In Commercial Distribution
- 05430003362068 ()
- Electrosurgical handpiece, reusable
Aurix software for use with the Aurix system (DI: 00627908080011)
The UDI for software is comprised of the following:
GTIN + Additional Product Identification Assigned by the Manufacturer (ADDITIONAL ID) (which represents the software version)
UDI Application Identifier for Additional Product Identification Assigned by the Manufacturer (ADDITIONAL ID) = 240
Vivosonic Inc
SWA002
Not in Commercial Distribution
- 00627908090027 ()
- Evoked-potential audiometer
Integrity software for use with the first generation Integrity V500 system (DI: 00627908010018) and the second generation of the Integrity V500 system
(DI: 00627908020017).
The UDI is comprised of the following:
GTIN + Additional Product Identification Assigned by the Manufacturer (ADDITIONAL ID) (which represents the software version)
UDI Application Identifier for Additional Product Identification Assigned by the Manufacturer (ADDITIONAL ID) = 240
Vivosonic Inc
SWA001
In Commercial Distribution
- 00627908090010 ()
- Otoacoustic emission system, battery-powered
- Evoked-potential audiometer
The zensor software system is a web and PC based tool assisting clinicians in managing patients being monitored with Intelesens' medical devices. The web and PC components of the software can be configured to be used individually or together.
The zensor+ software allows review of all physiological data that has been previously stored and downloaded from the monitoring device for later analysis by a clinician.
The system is intended to be used to obtain physiological readings for use in routine check-ups. Any events or variations in physiological readings are not intended to be used to summon emergency care.
INTELESENS LIMITED
PN0811
In Commercial Distribution
- 05060484630051 ()
- Electrocardiography telemetric monitoring system
The zensor software system is a web and PC based tool assisting clinicians in managing patients being monitored with Intelesens' medical devices. The web and PC components of the software can be configured to be used individually or together.
The zensoronline software has the option to receive wirelessly transmitted pre-defined event alerts from the Intelesens' monitoring device for review by healthcare practitioners and/or review all physiological data that has been previously stored and downloaded from the monitoring device for later analysis by a clinician.
The system is intended to be used to obtain physiological readings for use in routine check-ups. Any events or variations in physiological readings are not intended to be used to summon emergency care.
INTELESENS LIMITED
PN0810
In Commercial Distribution
- 05060484630044 ()
- Electrocardiography telemetric monitoring system