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No Description
BRAEMAR MANUFACTURING, LLC
900-0618-07
In Commercial Distribution
- B146C1MA070 ()
- Electrocardiographic long-term ambulatory recording analyser application software
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 arrhythmias.
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
900-0618-05
In Commercial Distribution
- B146C1MA051010 ()
- Electrocardiographic long-term ambulatory recording analyser application software
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 arrhythmias.
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
900-0618-04
In Commercial Distribution
- B146C1MA041010 ()
- Electrocardiographic long-term ambulatory recording analyser application software
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 arrhythmias.
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
900-0618-03
In Commercial Distribution
- B146C1MA031010 ()
- Electrocardiographic long-term ambulatory recording analyser application software
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 arrhythmias.
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
900-0618-02
In Commercial Distribution
- B146C1MA021010 ()
- Electrocardiographic long-term ambulatory recording analyser application software
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 arrhythmias.
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
900-0618-01
In Commercial Distribution
- B146C1MA011010 ()
- Electrocardiographic long-term ambulatory recording analyser application software
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
Bloodstream Software is a standalone software application used in blood screening. Bloodstream Software may be configured to connect to instrumentation in a blood screening facility including pipetting systems (poolers), automation software (a track system), blood testing instrumentation, and Laboratory Information Systems (LIS). Bloodstream Software also contains a user interface (UI) that allows users of Bloodstream Software to monitor the testing progress of donor samples in their lab, as well as allowing limited interaction in the testing process, such as modifying or canceling orders, or reviewing and approving results.
DATA INNOVATIONS LLC
1.2
In Commercial Distribution
- B180BSB01120 ()
BSB01
- Blood bank information system application software
Bloodstream Software is a standalone software application used in blood screening. Bloodstream Software may be configured to connect to instrumentation in a blood screening facility including pipetting systems (poolers), automation software (a track system), blood testing instrumentation, and Laboratory Information Systems (LIS). Bloodstream Software also contains a user interface (UI) that allows users of Bloodstream Software to monitor the testing progress of donor samples in their lab, as well as allowing limited interaction in the testing process, such as modifying or canceling orders, or reviewing and approving results.
DATA INNOVATIONS LLC
1.1
In Commercial Distribution
- B180BSB01110 ()
BSB01
- Blood bank information system application software
Bloodstream Software is a standalone software application used in blood screening. Bloodstream Software may be configured to connect to instrumentation in a blood screening facility including pipetting systems (poolers), automation software (a track system), blood testing instrumentation, and Laboratory Information Systems (LIS). Bloodstream Software also contains a user interface (UI) that allows users of Bloodstream Software to monitor the testing progress of donor samples in their lab, as well as allowing limited interaction in the testing process, such as modifying or canceling orders, or reviewing and approving results.
DATA INNOVATIONS LLC
1.0
In Commercial Distribution
- B180BSB01100 ()
BSB01
- Blood bank information system application software
No Description
INTELLIGENT HEARING SYSTEMS CORP.
M815000
In Commercial Distribution
- 00817020020884 ()
- Visual-reinforcement audiometer
No Description
INTELLIGENT HEARING SYSTEMS CORP.
M817000
In Commercial Distribution
- 00817020020877 ()
- Tone audiometer
No Description
INTELLIGENT HEARING SYSTEMS CORP.
M814000
In Commercial Distribution
- 00817020020860 ()
- Bioelectrical signal analysis software
No Description
INTELLIGENT HEARING SYSTEMS CORP.
M813000
In Commercial Distribution
- 00817020020853 ()
- Bioelectrical signal analysis software
No Description
INTELLIGENT HEARING SYSTEMS CORP.
M811007
In Commercial Distribution
- 00817020020815 ()
- Bioelectrical signal analysis software
No Description
INTELLIGENT HEARING SYSTEMS CORP.
M811000
In Commercial Distribution
- 00817020020808 ()
- Bioelectrical signal analysis software
No Description
PATHKEEPER SURGICAL LTD
PSW0001-01
In Commercial Distribution
- 07290019120148 ()
- Optical surgical navigation device tracking system
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
HaGuide Software
In Commercial Distribution
- 07290114064545 ()
407-000024-00
- Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
HaGuide Software
In Commercial Distribution
- 07290114064071 ()
407-000024-00
- Brain-responsive electrical stimulation system
Raypilot Software, including user friendly functions, is installed on a dedicated computer and visualized on a display in the control as well as treatment room.
Micropos Medical AB (Publ)
1
In Commercial Distribution
- 07350007953049 ()
3004
- Radiation therapy invasive marker lesion localization system
moorVMS-PC Software V4.0 is a Windows based software package designed to work with the moorVMS setup and is fully compatible with all of the existing modules.
MOOR INSTRUMENTS LIMITED
4
In Commercial Distribution
- 15060484490096 ()
- Tissue saturation oximeter
- Laser Doppler blood flowmeter
tetraONE
Beckman Coulter, Inc.
6915050
In Commercial Distribution
- 15099590572679 ()
6915050
- Laboratory instrument/analyser application software IVD
stemONE
Beckman Coulter, Inc.
6915452
In Commercial Distribution
- 15099590559519 ()
6915452
- Laboratory instrument/analyser application software IVD
Software Medical Device GE Client Software V8.0
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
AltiX
In Commercial Distribution
- 00195278507525 ()
5889605
- Cardiac catheterization monitoring system
- Cardiac electrophysiology analysis system
Software Medical Device GE Client Software V9.0
Ge Medical Systems Information Technologies, Inc.
AltiX AI.i
In Commercial Distribution
- 00195278931504 ()
5973597
- Cardiac electrophysiology analysis system
- Cardiac catheterization monitoring system
Dental Imaging Software. Software Version 2.x.x.
DÜRR DENTAL SE
E7300
In Commercial Distribution
- E247E7300 ()
- General-purpose dental x-ray system application software
Dental Imaging Software. Software Version 5.x.x.
DÜRR DENTAL SE
E7200A
Not in Commercial Distribution
- E247E7200A0 ()
- General-purpose dental x-ray system application software
Software Medical Device GE Client Software V7.0
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
A1
Not in Commercial Distribution
- 00840682145763 ()
- Cardiac catheterization monitoring system
- Cardiac electrophysiology analysis system
ZephyrLIFE Hospital Application Software Application?
ZEPHYR TECHNOLOGY LLC
Software Hospital
Not in Commercial Distribution
- 10884521712904 ()
Software Hospital
- Electrosurgical return electrode, single-use
ZephyrLIFE Home HealthHub Patient Software Application?
ZEPHYR TECHNOLOGY LLC
Software Home
Not in Commercial Distribution
- 10884521712898 ()
Software Home
- Electrosurgical return electrode, single-use
No Description
OLYMPUS MEDICAL SYSTEMS CORP.
MAJ-2039
Not in Commercial Distribution
- 04953170360824 ()
N5368940
- Video capsule endoscopy system application software
Cardea SOLO PC Software - ECG analysis software (D300)
CARDIAC INSIGHT, INC.
D300
In Commercial Distribution
- 00857553006139 ()
D300
- Electrocardiographic ambulatory recorder
Software Upgrade from v22 to Natus Elite Software
NATUS NEUROLOGY INCORPORATED
033418
In Commercial Distribution
- 00382830061971 ()
- Electromyograph
No Description
Hinacom Software and Technology, Ltd.
V2.0
In Commercial Distribution
- 06970901070010 ()
- Radiological PACS software
No Description
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
115-053713-00
In Commercial Distribution
- 06936415905569 ()
- General-purpose multi-parameter bedside monitor
No Description
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
115-046969-00
In Commercial Distribution
- 06944904096728 ()
- Analytical scalp electrode, single-use
Procleix NAT Manager Software is designed to collect data from Procleix assays, instruments, and pooling/lysis software, which allows operators to track individual donor blood samples and link them to the appropriate test results. The software collates the results of lysing, pooling and testing, assigns outcomes to individual samples according to a testing algorithm, and formats output files that can be sent to a Laboratory Information Management System (LIMS). Procleix NAT Manager Software also produces a variety of summary informational and analytical reports.
BIOMEDICAL DATA SOLUTIONS LIMITED
1.2
In Commercial Distribution
- 05060496770011 ()
- Blood bank information system application software
cobas Synergy Software is software which controls pre-analytic instruments used to manage tubes and pipette liquid sample material to form pools of samples, as a front-end to the cobas® 6800/8800 Systems. cobas Synergy Software is intended for use in plasma fractionation and whole blood testing laboratories. The software is intended to be used by personnel who are trained in its operation and are familiar with the associated assays and instruments.
BIOMEDICAL DATA SOLUTIONS LIMITED
1
In Commercial Distribution
- 05060496770004 ()
- Blood bank information system application software
SedLine Module
MASIMO CORPORATION
4497
In Commercial Distribution
- 00843997013895 ()
4497
- Patient monitoring system module, electroencephalographic
RD Sedline Patient Cable
MASIMO CORPORATION
4298
In Commercial Distribution
- 00843997012485 ()
- Patient monitoring system module, electroencephalographic
SedLine Module
MASIMO CORPORATION
4432
In Commercial Distribution
- 00843997013475 ()
4432
- Patient monitoring system module, electroencephalographic
No Description
Neurowave Systems Inc.
NS-901
In Commercial Distribution
- B746NS90101 ()
- Anaesthesia depth monitor
RD Sedline EEG Sensor Pediatric
MASIMO CORPORATION
4329
In Commercial Distribution
- 00843997012805 ()
- 10843997012802 ()
4329
- Analytical scalp electrode, single-use
D/L, E500 CONTROL PANEL MODULE, US VERSION
Covidien LP
186-0199R-SF
In Commercial Distribution
- 10884521713055 ()
- Neurophysiologic monitoring system
BIS LoC 2 Channel, Refurbished, Software Version 1.13 For use with Philips Patient Monitors
Covidien LP
186-0199R-PH
In Commercial Distribution
- 10884521702868 ()
- Neurophysiologic monitoring system
BIS LoC 2 Channel Refurbished, Software Version 1.13 For use with Philips Patient Monitors
Covidien LP
186-0195-PHSPS
In Commercial Distribution
- 10884521702851 ()
- Neurophysiologic monitoring system
BISX Module,Refurbished, Software Version 1.13
Covidien LP
186-0199-DM
In Commercial Distribution
- 10884521160231 ()
- Neurophysiologic monitoring system
A2000 Monitoring System,Refurbished
Covidien LP
186-1005-RFB
Not in Commercial Distribution
- 10884521157545 ()
- Anaesthesia depth monitor
Monitoring System,Refurbished
Covidien LP
186-1001-JP
In Commercial Distribution
- 10884521157538 ()
- Anaesthesia depth monitor
BISX Module,Refurbished, Software Version 1.13
Covidien LP
186-0199-GE
In Commercial Distribution
- 10884521186064 ()
- Neurophysiologic monitoring system