ViSi Mobile System Package 92-10096

GUDID 00850733007124

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.

SOTERA WIRELESS, INC.

Single-patient intensive/general healthcare physiologic monitoring system
Primary Device ID00850733007124
NIH Device Record Keybf5f81a4-b2a7-4734-bd06-da8a91c77aaa
Commercial Distribution StatusIn Commercial Distribution
Brand NameViSi Mobile System Package
Version Model Number3-lead IEC
Catalog Number92-10096
Company DUNS167142491
Company NameSOTERA WIRELESS, INC.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone858-373-4823
Emaillan.herrington@soterawireless.com
Phone858-373-4823
Emaillan.herrington@soterawireless.com
Phone858-373-4823
Emaillan.herrington@soterawireless.com
Phone858-373-4823
Emaillan.herrington@soterawireless.com
Phone858-373-4823
Emaillan.herrington@soterawireless.com
Phone858-373-4823
Emaillan.herrington@soterawireless.com
Phone858-373-4823
Emaillan.herrington@soterawireless.com
Phone858-373-4823
Emaillan.herrington@soterawireless.com
Phone858-373-4823
Emaillan.herrington@soterawireless.com
Phone858-373-4823
Emaillan.herrington@soterawireless.com
Phone858-373-4823
Emaillan.herrington@soterawireless.com
Phone858-373-4823
Emaillan.herrington@soterawireless.com
Phone858-373-4823
Emaillan.herrington@soterawireless.com
Phone858-373-4823
Emaillan.herrington@soterawireless.com
Phone858-373-4823
Emaillan.herrington@soterawireless.com
Phone858-373-4823
Emaillan.herrington@soterawireless.com
Phone858-373-4823
Emaillan.herrington@soterawireless.com
Phone858-373-4823
Emaillan.herrington@soterawireless.com
Phone858-373-4823
Emaillan.herrington@soterawireless.com
Phone858-373-4823
Emaillan.herrington@soterawireless.com
Phone858-373-4823
Emaillan.herrington@soterawireless.com
Phone858-373-4823
Emaillan.herrington@soterawireless.com
Phone858-373-4823
Emaillan.herrington@soterawireless.com
Phone858-373-4823
Emaillan.herrington@soterawireless.com
Phone858-373-4823
Emaillan.herrington@soterawireless.com
Phone858-373-4823
Emaillan.herrington@soterawireless.com
Phone858-373-4823
Emaillan.herrington@soterawireless.com
Phone858-373-4823
Emaillan.herrington@soterawireless.com
Phone858-373-4823
Emaillan.herrington@soterawireless.com
Phone858-373-4823
Emaillan.herrington@soterawireless.com
Phone858-373-4823
Emaillan.herrington@soterawireless.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100850733007124 [Primary]

FDA Product Code

MHXMonitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2020-02-06
Device Publish Date2018-05-21

On-Brand Devices [ViSi Mobile System Package]

00850733007131The ViSi Mobile Monitoring System is intended for use by clinicians and medically qualified pers
00850733007124The ViSi Mobile Monitoring System is intended for use by clinicians and medically qualified pers
00850733007117The ViSi Mobile Monitoring System is intended for use by clinicians and medically qualified pers
00850733007100The ViSi Mobile Monitoring System is intended for use by clinicians and medically qualified pers

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