soterawireless.comViSi Mobile Monitoring System
Sotera Wireless, Inc.
SOTERA WIRELESS
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3009673645 | 3009673645 | SOTERA WIRELESS | 1 | N | 2026-01-01 | 5841 Edison Place Suite #140 Carlsbad CA US 92008 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 00850733007032 | ViSi - ViSi NIBP Adapter is an accessory intended to connect ViSi Cuff Module with a non-ViSi NIBP Cuff. | 1-858-373-4823 | Lan.herrington@soterawireless.com |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 142285 | 1274709313 | K180472 | ViSi Mobile Monitoring System | MHX | 2018-06-19 |
| 142285 | 1582600551 | K152341 | ViSi Mobile Monitoring System | MWI | 2015-12-14 |
| 142285 | 1070775891 | K142827 | Visi Mobile Monitoring System, Visi Mobile Chest Sensor | MHX | 2015-07-20 |
| 142285 | 1438597922 | K141496 | MULTI-PARAMETER MOBILE CAREGUIDE 4100 OXIMETER | MUD | 2014-08-04 |
| 142285 | 1609488231 | K133923 | MULTI-PARAMETER MOBILE CAREGUIDE 3100 OXIMETER WITH TABLET | MUD | 2014-04-11 |
| 142285 | 1271698124 | K122645 | MOBILE CAREGUIDE 2100 OXIMETER | MUD | 2012-12-05 |
| 142285 | 1143064646 | K113656 | CAREGUIDE OXIMETER | MUD | 2012-07-26 |
| 142285 | 1365711286 | K112478 | VISI MOBILE MONITORING SYSTEM | MWI | 2012-03-22 |
| 142285 | 1737937332 |
Product Codes Associated With Registrations#
PMN#
ViSi Mobile Monitoring System
SOTERA WIRELESS, INC
Visi Mobile Monitoring System, Visi Mobile Chest Sensor
Sotera Wireless, Inc.
ViSi Mobile Monitoring System
Sotera Wireless, Inc.
Visi Mobile Monitoring System
Sotera Wireless, Inc.
VISI MOBILE MONITIORING SYSTEM
SOTERA WIRELESS, INC
VISI MOBILE MONITORING SYSTEM
SOTERA WIRELESS, INC
VISI MOBILE MONITORING SYSTEM
SOTERA WIRELESS, INC
VISI MOBILE MONITORING SYSTEM
SOTERA WIRELESS, INC
GUDID#
ViSi - Thumb Tape (Qty 100)
2020-06-24
ViSi - ViSi NIBP Adapter is an accessory intended to connect ViSi Cuff Module with a non-ViSi NIBP Cuff.
2016-09-19
ViSi - Thumb Wrap (Qty 100)
2020-06-24
ViSi - Disposable Adult Cuff, Small (Qty 20)
2020-06-24
ViSi - Disposable Adult Cuff, Medium (Qty 20)
2020-06-24
ViSi - Disposable Adult Cuff, Medium+ (Qty 20)
2020-06-24
ViSi - Disposable Adult Cuff, Large (Qty 20)
2020-06-24
ViSi - Disposable Adult Cuff, Large+ (Qty 20)
2020-06-24
ViSi - Disposable Wrist Cradle, Small (Qty 20)
2020-06-24
ViSi - Disposable Wrist Cradle, Medium (Qty 20)
2020-06-24
ViSi - Disposable Wrist Cradle, Large (Qty 20)
2020-06-24
ViSi - Reusable cNIBP & SpO2 Thumb Sensor
2020-06-24
ViSi - ViSi Mobile Cuff Module, Refurbished
2020-06-24
ViSi - ViSi Mobile Charger, 2-Bay
2020-06-24
ViSi - ViSi Mobile Charger, 8-Bay
2020-06-24
ViSi - Chest Sensor Securements (Qty 100)
2020-06-24
ViSi - ViSi Emergency Medical Surveillance (EMS) Kit
2020-06-24
ViSi - Chest Sensor Securements, 3M
2020-06-24
ViSi - 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.
2016-09-19
ViSi - 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).
2016-09-19
ViSi - 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).
2016-09-19
ViSi - 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).
2016-09-19
ViSi - 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).
2016-09-19
ViSi - 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).
2016-09-19
ViSi - 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).
2016-09-19
ViSi - 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.
2018-01-08
ViSi - 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.
2018-01-08
ViSi Mobile System Package - 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.
2018-05-21
ViSi Mobile System Package - 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.
2018-05-21
ViSi Mobile System Package - 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.
2018-05-21
ViSi Mobile System Package - 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.
2018-05-21
ViSi - Thumb Wrap (Qty 100)
2020-06-24
ViSi - Disposable Adult Cuff, Small (Qty 20)
2020-06-24
ViSi - Disposable Adult Cuff, Medium (Qty 20)
2020-06-24
ViSi - Disposable Adult Cuff, Medium+ (Qty 20)
2020-06-24
ViSi - Disposable Adult Cuff, Large (Qty 20)
2020-06-24
ViSi - Disposable Adult Cuff, Large+ (Qty 20)
2020-06-24
ViSi - Disposable Wrist Cradle, Small (Qty 20)
2020-06-24
ViSi - Disposable Wrist Cradle, Medium (Qty 20)
2020-06-24
ViSi - Disposable Wrist Cradle, Large (Qty 20)
2020-06-24