Sotera Wireless, Inc.

Address:5841 Edison Place,Carlsbad,CA,92008,US

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- Catalog Number : 92-10010

Device Description : The ViSi Mobile Monitoring System is intended for use by clinicians and medicall The ViSi Mobile Monitoring System is intended for use by clinicians and medically qualified personnel for single or multi-parameter vital signs monitoring of adult patients (18 years or older). It is indicated for ECG (3 or 5 lead-wire), respiration rate (RESP), heart rate (HR), noninvasive blood pressure (NIBP), continuous noninvasive blood pressure (cNIBP), noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (PR), and skin temperature (TEMP) in hospital-based facilities; including, general medical-surgical floors, intermediate care floors, and emergency departments.The ViSi Mobile Monitoring System may be used as standalone devices or networked to ViSi Mobile Remote Viewers through wireless 802.11 communication.The ViSi Mobile InSight is an optional secondary notification system that communicates alarms directly to an assigned caregiver. It is intended to supplement the primary alarming devices which originate in the ViSi Mobile patient worn device.

Device Class : 2

Duns Number: 167142491

Premarket Exempt : No

Product Code : MWI

Prescription Use : Yes

Device Count : 1

- Catalog Number : 92-10011

Device Description : ViSi Cuff Module is an accessory intended for use together with the ViSi Mobile ViSi Cuff Module is an accessory intended for use together with the ViSi Mobile Monitor to measure noninvasive blood pressure (NIBP) of adult patients (18 years or older).

Device Class : 2

Duns Number: 167142491

Premarket Exempt : No

Product Code : DXN

Prescription Use : Yes

Device Count : 1

- Catalog Number : 92-10020

Device Description : The ViSi thumb sensor is an accessory intended to use together with the ViSi Mob The ViSi thumb sensor is an accessory intended to use together with the ViSi Mobile Monitor to measure SpQ2, pulse rate and continuous noninvasive blood pressure (cNIBP) of adult patients (18 years or older).

Device Class : 2

Duns Number: 167142491

Premarket Exempt : No

Product Code : DQA

Prescription Use : Yes

Device Count : 1

- Catalog Number :

Device Description : ViSi NIBP Adapter is an accessory intended to connect ViSi Cuff Module with a no ViSi NIBP Adapter is an accessory intended to connect ViSi Cuff Module with a non-ViSi NIBP Cuff.

Device Class : 2

Duns Number: 167142491

Premarket Exempt : No

Product Code : DXN

Prescription Use : Yes

Device Count : 1

- Catalog Number : 93-10013

Device Description : ViSi chest sensor is an accessory intended to use together with the ViSi Mobile ViSi chest sensor is an accessory intended to use together with the ViSi Mobile Monitor to measure ECG, heart rate, respiration rate and temperature of adult patients (18 years or older).

Device Class : 2

Duns Number: 167142491

Premarket Exempt : No

Product Code : DRT

Prescription Use : Yes

Device Count : 1

- Catalog Number : 93-10015

Device Description : ViSi chest sensor is an accessory intended to use together with the ViSi Mobile ViSi chest sensor is an accessory intended to use together with the ViSi Mobile Monitor to measure ECG, heart rate, respiration rate and temperature of adult patients (18 years or older).

Device Class : 2

Duns Number: 167142491

Premarket Exempt : No

Product Code : DRT

Prescription Use : Yes

Device Count : 1

- Catalog Number : 93-10017

Device Description : ViSi chest sensor is an accessory intended to use together with the ViSi Mobile ViSi chest sensor is an accessory intended to use together with the ViSi Mobile Monitor to measure ECG, heart rate, respiration rate and temperature of adult patients (18 years or older).

Device Class : 2

Duns Number: 167142491

Premarket Exempt : No

Product Code : DRT

Prescription Use : Yes

Device Count : 1

- Catalog Number : 93-10019

Device Description : ViSi chest sensor is an accessory intended to use together with the ViSi Mobile ViSi chest sensor is an accessory intended to use together with the ViSi Mobile Monitor to measure ECG, heart rate, respiration rate and temperature of adult patients (18 years or older).

Device Class : 2

Duns Number: 167142491

Premarket Exempt : No

Product Code : DRT

Prescription Use : Yes

Device Count : 1

- Catalog Number : 93-10146

Device Description : The ViSi Mobile Monitoring System is intended for use by clinicians and medicall The ViSi Mobile Monitoring System is intended for use by clinicians and medically qualified personnel for single or multi-parameter vital signs monitoring of adult patients (18 years or older). It is indicated for ECG (3 or 5 lead-wire), respiration rate (RESP), heart rate (HR), noninvasive blood pressure (NIBP), continuous noninvasive blood pressure (cNIBP), noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (PR), and skin temperature (TEMP) in hospital-based facilities; including, general medical-surgical floors, intermediate care floors, and emergency departments.The ViSi Mobile Monitoring System may be used as standalone devices or networked to ViSi Mobile Remote Viewers through wireless 802.11 communication.The ViSi Mobile InSight is an optional secondary notification system that communicates alarms directly to an assigned caregiver. It is intended to supplement the primary alarming devices which originate in the ViSi Mobile patient worn device.

Device Class : 2

Duns Number: 167142491

Premarket Exempt : No

Product Code : MWI

Prescription Use : Yes

Device Count : 1

- Catalog Number : 93-10145

Device Description : The ViSi Mobile Monitoring System is intended for use by clinicians and medicall The ViSi Mobile Monitoring System is intended for use by clinicians and medically qualified personnel for single or multi-parameter vital signs monitoring of adult patients (18 years or older). It is indicated for ECG (3 or 5 lead-wire), respiration rate (RESP), heart rate (HR), noninvasive blood pressure (NIBP), continuous noninvasive blood pressure (cNIBP), noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (PR), and skin temperature (TEMP) in hospital-based facilities; including, general medical-surgical floors, intermediate care floors, and emergency departments.The ViSi Mobile Monitoring System may be used as standalone devices or networked to ViSi Mobile Remote Viewers through wireless 802.11 communication.The ViSi Mobile InSight is an optional secondary notification system that communicates alarms directly to an assigned caregiver. It is intended to supplement the primary alarming devices which originate in the ViSi Mobile patient worn device.

Device Class : 2

Duns Number: 167142491

Premarket Exempt : No

Product Code : MWI

Prescription Use : Yes

Device Count : 1