DEVICE: Viewfinder remote app (00690103215847)

Download: XML | JSON
Print
Device Record History
View all sections | Close all sections

Device Identifier (DI) Information
Viewfinder remote app
VFREM
In Commercial Distribution
VFREM
Edwards Lifesciences LLC
00690103215847
GS1

1
134139174 *Terms of Use
Viewfinder remote app
CLOSE

Device Characteristics
Labeling does not contain MRI Safety Information
No
No
No
Yes
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
66386 Bedside monitor remote-viewing software, physiological parameter
An 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.
Active false
33586 General-purpose multi-parameter bedside monitor
An electrically-powered device/device assembly 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 set-up by the patient bedside and 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 and is not intended to be worn on the body.
Active false
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
FLL Thermometer, Electronic, Clinical
DQE Catheter, Oximeter, Fiber-Optic
DQK Computer, Diagnostic, Programmable
DSB Plethysmograph, Impedance
DXN System, Measurement, Blood-Pressure, Non-Invasive
MUD Oximeter, Tissue Saturation
QAQ Adjunctive Predictive Cardiovascular Indicator
CLOSE

FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization
No
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

Storage and Handling

[?]
Storage and Handling
No storage/handling found
CLOSE

Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
CLOSE

Device Record Status
3e06fe49-a8c9-432c-94ee-46942940e94a
July 25, 2023
2
January 13, 2023
CLOSE

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
No
No
No
No
No CLOSE

Customer Contact

[?]
+1(800)822-9637
tech_support@edwards.com
CLOSE