DEVICE: Neurovirtual (00850008393327)

Device Identifier (DI) Information

Neurovirtual
Maxxi Flow Sensor 7ft TP connector
In Commercial Distribution
SI1486
NEUROVIRTUAL USA, INC.
00850008393327
GS1

1
791140622 *Terms of Use
The Maxxi Flow Sensor is a thermocouple intended to acquire the respiratory signal
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Device Characteristics

MR Unsafe
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?
33843 Polysomnograph
A mains electricity (AC-powered) device designed to record physiological signals from a sleeping patient to assess sleep disorders (e.g., insomnia, snoring or sleep apnoea). The device is typically computerized and usually records an electrocardiogram (ECG), electroencephalogram (EEG), chest wall motion, airflow at both the nose and the mouth, eye movements, haemoglobin oxygen saturation (SpO2) and electromyogram (EMG). Parameters may be added or omitted depending on the study being performed. The device includes multiple electrodes/sensors placed on the patient in specific areas as well as amplifiers and filters for recording.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
MNR Ventilatory Effort Recorder
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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
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Storage and Handling

[?]
Storage and Handling
Handling Environment Humidity: between 5 and 95 Percent (%) Relative Humidity
Handling Environment Temperature: between 5 and 40 Degrees Celsius
Handling Environment Temperature: between 40 and 104 Degrees Fahrenheit
Storage Environment Humidity: between 5 and 95 Percent (%) Relative Humidity
Storage Environment Temperature: between -20 and 60 Degrees Celsius
Storage Environment Temperature: between -4 and 140 Degrees Fahrenheit
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

728e93c2-0067-44dc-9a4c-756dc79589ef
December 30, 2020
1
December 22, 2020
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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
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
No
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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