DEVICE: WVSM Wireless Vital Signs Monitor (B3945000001120)
Device Identifier (DI) Information
WVSM Wireless Vital Signs Monitor
WVSM 5.0
In Commercial Distribution
500-0001-12
ATHENA GTX, INC.
WVSM 5.0
In Commercial Distribution
500-0001-12
ATHENA GTX, INC.
Wireless Patient Monitor
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? |
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36872 | Multiple vital physiological parameter monitoring system, clinical |
An assembly of electrically-powered devices designed to be used by a healthcare professional in a clinical setting for intermittent or continuous assessment of several vital physiologic parameters [e.g., electrocardiogram (ECG), noninvasive blood pressure (NIBP), pulse rate, temperature, haemoglobin oxygen saturation (SpO2)]. It includes both physiological parameter sensors, probes, and/or electrodes (e.g., ECG electrodes, blood pressure cuff) and processing hardware with dedicated software. It typically incorporates a monitoring screen, but may alternatively be connected to an off-the-shelf device for display; it is not intended to be worn on the body.
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Active | false |
37595 | Multiple-patient intensive/general healthcare physiologic monitoring system |
An assembly of electrically-powered devices designed for continuous assessment of several vital physiologic parameters (e.g., ECG, blood pressure, heart rate, temperature, cardiac output, apnoea, and respiratory/anaesthetic gas concentrations) of more than one patient in intensive or general healthcare settings. It typically includes a central station monitor that receives, consolidates, and displays the information, and bedside patient monitors to provide data from each patient; it often includes programmable alarms, portable radio transmitters (with sensors), receivers, and antennas (telemetry systems) to allow monitoring during patient ambulation or transportation.
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Obsolete | false |
FDA Product Code
[?]Product Code | Product Code Name |
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MWI | Monitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms) |
DQA | Oximeter |
DRG | Transmitters And Receivers, Physiological Signal, Radiofrequency |
DXN | System, Measurement, Blood-Pressure, Non-Invasive |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Storage Environment Temperature: between -20 and 60 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
d0af3a77-3440-4ba2-938e-3ddd419db872
February 17, 2025
7
December 06, 2017
February 17, 2025
7
December 06, 2017
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
515-288-3360
info@athenagtx.com
info@athenagtx.com