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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
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
900-0618-02
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
"ANS1 Software is inetended for use: ANS1 Software is an optional software accessory for use with the following models with datamanagement capabilities: a) TM-Oxi (Oximeter and blood pressure device) and b) SudoPath
(Galvanic Skin response) and c) ES-BC (Body Composition Analyzer).When used in combination with TM-Oxi and/or SudoPath, and/or ES-BC devices, the ANS1software uploads the data of the devices, analyzes the data, and then displays the data in ac omputer for enhanced data management.
The ANS1 software is intended for use in clinical settings as an aid for health careprofessionals to review, analyze, and evaluate the historical tests results."
LD TECHNOLOGY, LLC
G001
In Commercial Distribution
- B322G0011 ()
- Manual-inflation electronic sphygmomanometer, non-portable
- Skin electrical conductance meter
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