Sotera Wireless, Inc.

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

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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 : MHX

Prescription Use : Yes

Device Count : 1

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 : MHX

Prescription Use : Yes

Device Count : 1

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 : MHX

Prescription Use : Yes

Device Count : 1

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 : MHX

Prescription Use : Yes

Device Count : 1

- Catalog Number : 93-10129

Device Description : Reusable cNIBP & SpO2 Thumb Sensor

Device Class : 2

Duns Number: 167142491

Premarket Exempt : No

Product Code : DQA

Prescription Use : Yes

Device Count : 1

- Catalog Number : 93-10147

Device Description : ViSi Mobile Cuff Module, Refurbished

Device Class : 2

Duns Number: 167142491

Premarket Exempt : No

Product Code : DXN

Prescription Use : Yes

Device Count : 1

- Catalog Number : 93-10021

Device Description : Thumb Wrap (Qty 100)

Device Class : 2

Duns Number: 167142491

Premarket Exempt : No

Product Code : DQA

Prescription Use : Yes

Device Count : 100

- Catalog Number : 94-10189

Device Description : Disposable Adult Cuff, Small (Qty 20)

Device Class : 2

Duns Number: 167142491

Premarket Exempt : No

Product Code : DXN

Prescription Use : Yes

Device Count : 20

- Catalog Number : 94-10190

Device Description : Disposable Adult Cuff, Medium (Qty 20)

Device Class : 2

Duns Number: 167142491

Premarket Exempt : No

Product Code : DXN

Prescription Use : Yes

Device Count : 20

- Catalog Number : 94-10191

Device Description : Disposable Adult Cuff, Medium+ (Qty 20)

Device Class : 2

Duns Number: 167142491

Premarket Exempt : No

Product Code : DXN

Prescription Use : Yes

Device Count : 20