Home GUDID 00850733007001
ViSi
Primary DI 00850733007001
Brand ViSi
Company Sotera Wireless, Inc.
Model Mobile Monitor
Catalog number 92-10010
Device description 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.
Published 2016-09-19
Public version status Update
Distribution status In Commercial Distribution
MRI safety MR Unsafe
Rx true
Product Codes# Code, Name table Code Name MWI Monitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms)
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) Cardiovascular 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00850733007001 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00850733007001 00850733007001 850733007001 0850733007001
GMDN Terms# Term, Definition table Term Definition Single-patient intensive/general healthcare physiologic monitoring system An assembly of electrically-powered devices designed for the continuous assessment of several vital physiologic parameters (e.g., ECG, blood pressure, heart rate, temperature, cardiac output, apnoea, and respiratory/anaesthetic gas concentrations) of one patient in intensive or general healthcare settings. It typically includes a central station monitor that receives, consolidates, and displays the information, and/or a bedside patient monitor; it often includes programmable alarms, portable radio transmitters, receivers, and antennas (telemetry systems) to allow monitoring during patient ambulation or transportation; it is not dedicated to neonatal use.
Regulatory Flags# DUNS number 167142491 Device count 1 Serial number true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 10850733007183 ViSi Thumb Tape (Qty 100) 94-10007 2020-06-24 00850733007032 ViSi NIBP Adapter 2016-09-19 00850733007179 ViSi Thumb Wrap (Qty 100) 93-10021 2020-06-24 00850733007209 ViSi Disposable Adult Cuff, Small (Qty 20) 94-10189 2020-06-24 00850733007223 ViSi Disposable Adult Cuff, Medium (Qty 20) 94-10190 2020-06-24 00850733007247 ViSi Disposable Adult Cuff, Medium+ (Qty 20) 94-10191 2020-06-24 00850733007261 ViSi Disposable Adult Cuff, Large (Qty 20) 94-10192 2020-06-24 00850733007285 ViSi Disposable Adult Cuff, Large+ (Qty 20) 94-10193 2020-06-24 00850733007322 ViSi Disposable Wrist Cradle, Small (Qty 20) 94-10172 2020-06-24 00850733007346 ViSi Disposable Wrist Cradle, Medium (Qty 20) 94-10173 2020-06-24 00850733007360 ViSi Disposable Wrist Cradle, Large (Qty 20) 94-10174 2020-06-24 00850733007148 ViSi Reusable cNIBP & SpO2 Thumb Sensor 93-10129 2020-06-24 00850733007155 ViSi ViSi Mobile Cuff Module, Refurbished 93-10147 2020-06-24 00850733007377 ViSi ViSi Mobile Charger, 2-Bay 92-10022 2020-06-24 00850733007384 ViSi ViSi Mobile Charger, 8-Bay 92-10023 2020-06-24 00850733007407 ViSi Chest Sensor Securements (Qty 100) 94-10195 2020-06-24 00850733007414 ViSi ViSi Emergency Medical Surveillance (EMS) Kit 97-10259 2020-06-24 10850733007305 ViSi Chest Sensor Securements, 3M (Qty 100) 94-10012 2020-06-24 00850733007018 ViSi Cuff Module 92-10011 2016-09-19 00850733007025 ViSi Thumb Sensor 92-10020 2016-09-19
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