ViSi Mobile System Package 92-10093

GUDID 00850733007100

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 ID: 00850733007100
• NIH Device Record Key: deb1e690-05af-499a-adff-b81429219502
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ViSi Mobile System Package
• Version Model Number: 3-lead AAMI
• Catalog Number: 92-10093
• Company DUNS: 167142491
• Company Name: SOTERA WIRELESS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850733007100 [Primary]

FDA Product Code

• MHX: Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-02-06
• Device Publish Date: 2018-05-21

On-Brand Devices [ViSi Mobile System Package]

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