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No Description
GESIVA MEDICAL LLC
Medium Standard Tension Ring
In Commercial Distribution
- B598GMMST0001 ()
- B598GMMST0002 ()
- Penile vacuum device
No Description
GESIVA MEDICAL LLC
Large Standard Tension Ring
In Commercial Distribution
- B598GMLST0001 ()
- B598GMLST0002 ()
- Penile vacuum device
No Description
GESIVA MEDICAL LLC
Large High Tension Ring
In Commercial Distribution
- B598GMLHT0001 ()
- B598GMLHT0002 ()
- Penile vacuum device
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
ELISA HIGH POSITIVE CONTROL
UTAK LABORATORIES, INC.
ELISA HPC WB OSBI
In Commercial Distribution
- B800ELISAHPCWBOSBI5 ()
- B800ELISAHPCWBOSBI0 ()
- Total Volume: 5 Milliliter
ELISA HPC WB OSBI
- Multiple-type clinical chemistry analyte profile IVD, control
EIA STANDARD V3
UTAK LABORATORIES, INC.
EIA STD V3 WB DOJ
In Commercial Distribution
- B800EIASTDV3WBDOJ5 ()
- B800EIASTDV3WBDOJ0 ()
- Total Volume: 2 Milliliter
EIA STD V3 WB DOJ
- Multiple-type clinical chemistry analyte profile IVD, control
EIA NEGATIVE CALIBRATOR
UTAK LABORATORIES, INC.
EIA NEG U F RX
In Commercial Distribution
- B800EIANEGUFRX5 ()
- B800EIANEGUFRX0 ()
- Total Volume: 5 Milliliter
EIA NEG U F RX
- Multiple-type clinical chemistry analyte profile IVD, control
EIA CALIBRATOR LEVEL 2
UTAK LABORATORIES, INC.
EIA CAL 2 U F RX
In Commercial Distribution
- B800EIACAL2UFRX5 ()
- B800EIACAL2UFRX0 ()
- Total Volume: 5 Milliliter
EIA CAL 2 U F RX
- Multiple-type clinical chemistry analyte profile IVD, control
EIA C2 V3
UTAK LABORATORIES, INC.
EIA C2 V3 U F DOJ
In Commercial Distribution
- B800EIAC2V3UFDOJ5 ()
- B800EIAC2V3UFDOJ0 ()
- Total Volume: 2 Milliliter
EIA C2 V3 U F DOJ
- Multiple-type clinical chemistry analyte profile IVD, control
EIA C1 V3
UTAK LABORATORIES, INC.
EIA C1 V3 WB DOJ
In Commercial Distribution
- B800EIAC1V3WBDOJ5 ()
- B800EIAC1V3WBDOJ0 ()
- Total Volume: 2 Milliliter
EIA C1 V3 WB DOJ
- Multiple-type clinical chemistry analyte profile IVD, control