FDA.reportPublic FDA data

Viewfinder remote app

Primary DI
00690103215847
Brand
Viewfinder remote app
Company
Edwards Lifesciences LLC
Model
VFREM
Catalog number
VFREM
Device description
Viewfinder remote app
Published
2023-01-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DQECatheter, Oximeter, Fiber-Optic
DQKComputer, Diagnostic, Programmable
DSBPlethysmograph, Impedance
DXNSystem, Measurement, Blood-Pressure, Non-Invasive
FLLThermometer, Electronic, Clinical
MUDOximeter, Tissue Saturation
QAQAdjunctive Predictive Cardiovascular Indicator

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQECatheter, Oximeter, Fiber-OpticCardiovascular2
DQKComputer, Diagnostic, ProgrammableCardiovascular2
DSBPlethysmograph, ImpedanceCardiovascular2
DXNSystem, Measurement, Blood-Pressure, Non-InvasiveCardiovascular2
FLLContinuous Measurement ThermometerGeneral Hospital2
MUDOximeter, Tissue SaturationCardiovascular2
QAQAdjunctive Predictive Cardiovascular IndicatorCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00690103215847PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00690103215847006901032158476901032158470690103215847

GMDN Terms#

Term, Definition table
TermDefinition
Bedside monitor remote-viewing software, physiological parameterAn application software program intended to be installed on a smart device (e.g., smartphone, tablet) to allow a healthcare professional to view real-time and historical patient physiologic data [e.g., electrocardiogram (ECG), blood pressure, heart rate, SpO2] from bedside monitors via data transmission through a centralized patient monitor. It is designed for viewing data only as a telemedicine application intended to support, and not replace, standard patient monitoring.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)822-9637tech_support@edwards.com

Regulatory Flags#

DUNS number
134139174
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00690103219500Edwards Reusable Rail10500RL10500RL2025-07-09
00690103205084FOGARTY120403FP120403FP2020-09-15
00690103218602SWAN-GANZ TRUE SIZE096F6096F6P2026-03-16
00690103218626SWAN-GANZ TRUE SIZE111F7111F7P2026-03-16
00690103218633SWAN-GANZ TRUE SIZE114F7114F7P2026-03-16
00690103000245SWAN-GANZ TRUE SIZE096F6096F6P2016-09-03
00690103000269SWAN-GANZ110F5110F52016-09-03
00690103000276SWAN-GANZ TRUE SIZE111F7111F7P2016-09-03
00690103000313SWAN-GANZ TRUE SIZE114F7114F7P2016-09-03
00690103220223TRIFORMIS RESILIA Tricuspid Valve11300T2511300T252026-05-28
00690103220230TRIFORMIS RESILIA Tricuspid Valve11300T2711300T272026-05-28
00690103220247TRIFORMIS RESILIA Tricuspid Valve11300T2911300T292026-05-28
00690103220254TRIFORMIS RESILIA Tricuspid Valve11300T3111300T312026-05-28
00690103220261TRIFORMIS RESILIA Tricuspid Valve11300T3311300T332026-05-28
00690103019643HEART VALVE ACCESSORY1170117019MM2026-04-06
00690103019650HEART VALVE ACCESSORY1170117021MM2026-04-06
00690103019674HEART VALVE ACCESSORY1170117025MM2026-04-06
00690103019698HEART VALVE ACCESSORY1170117029MM2026-04-06
00690103019704HEART VALVE ACCESSORY1174M1174M242026-04-06
00690103019711HEART VALVE ACCESSORY1174M1174M262026-04-06

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