FDA.reportPublic FDA data

ViSi

Primary DI
00850733007070
Brand
ViSi
Company
Sotera Wireless, Inc.
Model
Chest Sensor, 3 Lead, IEC, WH
Catalog number
93-10019
Device description
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).
Published
2016-09-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DRTMonitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DRTMonitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)Cardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K152341000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K152341000ViSi Mobile Monitoring SystemSotera Wireless, Inc.2015-12-14MWI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850733007070PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850733007070008507330070708507330070700850733007070

GMDN Terms#

Term, Definition table
TermDefinition
Single-patient intensive/general healthcare physiologic monitoring systemAn 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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-858-427-4620support@soterawireless.com

Regulatory Flags#

DUNS number
167142491
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10850733007183ViSiThumb Tape (Qty 100)94-100072020-06-24
00850733007032ViSiNIBP Adapter2016-09-19
00850733007179ViSiThumb Wrap (Qty 100)93-100212020-06-24
00850733007209ViSiDisposable Adult Cuff, Small (Qty 20)94-101892020-06-24
00850733007223ViSiDisposable Adult Cuff, Medium (Qty 20)94-101902020-06-24
00850733007247ViSiDisposable Adult Cuff, Medium+ (Qty 20)94-101912020-06-24
00850733007261ViSiDisposable Adult Cuff, Large (Qty 20)94-101922020-06-24
00850733007285ViSiDisposable Adult Cuff, Large+ (Qty 20)94-101932020-06-24
00850733007322ViSiDisposable Wrist Cradle, Small (Qty 20)94-101722020-06-24
00850733007346ViSiDisposable Wrist Cradle, Medium (Qty 20)94-101732020-06-24
00850733007360ViSiDisposable Wrist Cradle, Large (Qty 20)94-101742020-06-24
00850733007148ViSiReusable cNIBP & SpO2 Thumb Sensor93-101292020-06-24
00850733007155ViSiViSi Mobile Cuff Module, Refurbished93-101472020-06-24
00850733007377ViSiViSi Mobile Charger, 2-Bay92-100222020-06-24
00850733007384ViSiViSi Mobile Charger, 8-Bay92-100232020-06-24
00850733007407ViSiChest Sensor Securements (Qty 100)94-101952020-06-24
00850733007414ViSiViSi Emergency Medical Surveillance (EMS) Kit97-102592020-06-24
10850733007305ViSiChest Sensor Securements, 3M (Qty 100)94-100122020-06-24
00850733007001ViSiMobile Monitor92-100102016-09-19
00850733007018ViSiCuff Module92-100112016-09-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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