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The Powered Breast Pump is intended to express and collect the breast milk of a nursing woman for the purpose of feeding the collected milk to a baby.
LANSINOH LABORATORIES SAGLIK GERECLERI TASARIM SANAYI TICARET LTD STI
Smartpump 3.0 Double Electric Breast Pump
In Commercial Distribution
- 60044677533517 ()
- 00044677533515 ()
53351
- Breast pump, electric
Ultrasonic Generator replacement for Generator BoneWelder 150-W1
Surgical Fusion Technologies GmbH
SupraFuser B Generator
Not in Commercial Distribution
- 07649990202204 ()
SF04-005-B
- Ultrasonic surgical system generator
No Description
Surgical Fusion Technologies GmbH
BoneWelder 150-W1
Not in Commercial Distribution
- 07649990202150 ()
BW04-001
- Ultrasonic surgical system generator
No Description
Surgical Fusion Technologies GmbH
SupraFuser Generator
In Commercial Distribution
- 07649990202075 ()
SF04-005
- Ultrasonic surgical system generator
Cutter Driver for Plaque Excision Systems
Covidien LP
FG02550
In Commercial Distribution
- 00821684043318 ()
- Mechanical atherectomy system catheter, peripheral
The Vios Monitoring System (VMS) Adapter and Chest Sensor are intended for use by medically qualified personnel for physiological vital signs monitoring of adult (18+) patients in healthcare facilities. It is indicated for use in monitoring of 7-Lead ECG, heart rate, respiratory rate, pulse rate, functional oxygen saturation of arterial hemoglobin, non-invasive blood pressure (NIBP) continuously and patient posture and activity. VMS allows for the input of body temperature and can display data from peripheral devices. VMS can generate alerts when rate-based cardiac arrhythmias are detected and when physiological vital signs fall outside of selected parameters.
The non-invasive blood pressure tracking is based on Pulse Arrival Time (PAT) which is obtained utilizing ECG and PPG signals, following a calibration process using an FDA-cleared oscillometric blood pressure monitor. This feature is not intended for use in critical care environment.
VMS can also generate alerts when cardiac arrhythmias (Tachycardia, Bradycardia, Asystole, Ventricular Tachycardia/Ventricular Fibrillation and Atrial Fibrillation/Atrial Flutter) are detected.
The ECG rhythm analysis is intended for use by medically qualified professionals in the identification of arrhythmia events and to aid in clinical review of arrhythmia and medical interventions.
The VMS Adapter and Chest Sensor are intended to be used by Vios-trained clinical professionals who also have a working knowledge of medical procedures, practices, and terminology, as required for monitoring patients.
MURATA VIOS, INC.
L2050R Pulse Oximetry Sensor
In Commercial Distribution
- B595L2050R0 ()
- B595L2050R1 ()
- B595L2050R2 ()
L2050R
- Pulse oximeter probe, reusable
- Pulse Co-oximeter probe, reusable
The Vios Monitoring System (VMS) Adapter and Chest Sensor are intended for use by medically qualified personnel for physiological vital signs monitoring of adult (18+) patients in healthcare facilities. It is indicated for use in monitoring of 7-Lead ECG, heart rate, respiratory rate, pulse rate, functional oxygen saturation of arterial hemoglobin, non-invasive blood pressure (NIBP) continuously and patient posture and activity. VMS allows for the input of body temperature and can display data from peripheral devices. VMS can generate alerts when rate-based cardiac arrhythmias are detected and when physiological vital signs fall outside of selected parameters.
The non-invasive blood pressure tracking is based on Pulse Arrival Time (PAT) which is obtained utilizing ECG and PPG signals, following a calibration process using an FDA-cleared oscillometric blood pressure monitor. This feature is not intended for use in critical care environment.
VMS can also generate alerts when cardiac arrhythmias (Tachycardia, Bradycardia, Asystole, Ventricular Tachycardia/Ventricular Fibrillation and Atrial Fibrillation/Atrial Flutter) are detected.
The ECG rhythm analysis is intended for use by medically qualified professionals in the identification of arrhythmia events and to aid in clinical review of arrhythmia and medical interventions.
The VMS Adapter and Chest Sensor are intended to be used by Vios-trained clinical professionals who also have a working knowledge of medical procedures, practices, and terminology, as required for monitoring patients.
MURATA VIOS, INC.
L2050G Adapter
In Commercial Distribution
- B595L2050G0 ()
L2050G
- Cardiac arrhythmia monitoring system
- Wearable multiple vital physiological parameter monitoring system
The Vios Monitoring System (VMS) Adapter and Chest Sensor are intended for use by medically qualified personnel for physiological vital signs monitoring of adult (18+) patients in healthcare facilities. It is indicated for use in monitoring of 7-Lead ECG, heart rate, respiratory rate, pulse rate, functional oxygen saturation of arterial hemoglobin, non-invasive blood pressure (NIBP) continuously and patient posture and activity. VMS allows for the input of body temperature and can display data from peripheral devices. VMS can generate alerts when rate-based cardiac arrhythmias are detected and when physiological vital signs fall outside of selected parameters.
The non-invasive blood pressure tracking is based on Pulse Arrival Time (PAT) which is obtained utilizing ECG and PPG signals, following a calibration process using an FDA-cleared oscillometric blood pressure monitor. This feature is not intended for use in critical care environment.
VMS can also generate alerts when cardiac arrhythmias (Tachycardia, Bradycardia, Asystole, Ventricular Tachycardia/Ventricular Fibrillation and Atrial Fibrillation/Atrial Flutter) are detected.
The ECG rhythm analysis is intended for use by medically qualified professionals in the identification of arrhythmia events and to aid in clinical review of arrhythmia and medical interventions.
The VMS Adapter and Chest Sensor are intended to be used by Vios-trained clinical professionals who also have a working knowledge of medical procedures, practices, and terminology, as required for monitoring patients.
MURATA VIOS, INC.
CS2050 Chest Sensor
In Commercial Distribution
- B595CS20500 ()
- B595L2050G1 ()
CS2050
- Cardiac arrhythmia monitoring system
- Wearable multiple vital physiological parameter monitoring system
The Zeto ONE Head Unit is a detachable part of the Zeto ONE, which is an EEG system intended for prescription use in healthcare facility, home, and specific transport environments to acquire, transmit, display and store EEG and auxiliary signals for adults and children, not including newborns.
The Head Unit component of the Zeto ONE is intended to hold electrodes on the subject's scalp and aquire electric signals produced by human brain activity.
ZETO INC
ZP-120-11011
In Commercial Distribution
- B675ONEHU1 ()
- Regular
- Small
- Electroencephalograph
Upper arm blood pressure monitor.
BODYTRACE, INC
BT104O
In Commercial Distribution
- B726BT104O2 ()
- B726BT104O1 ()
- B726BT104O0 ()
- Automatic-inflation electronic sphygmomanometer, portable, arm/wrist