DEVICE: SOMNOscreen plus PSG+ AASM Set (04250413401932)

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Device Identifier (DI) Information

SOMNOscreen plus PSG+ AASM Set
SSP201A
SSP201A
SOMNOmedics GmbH
04250413401932
GS1
1
No description.
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Device Characteristics

Labeling does not contain MRI Safety Information
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GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Polygraph A multichannel physiologic graphic recorder designed for the simultaneous recording of a number of different physiologic parameters, e.g., electrocardiogram (ECG), blood pressure, electroencephalogram (EEG), temperature or respiration. This device is frequently used for testing the truth of a person's statements (i.e., used as a "lie detector").
Polysomnography analyser A mains electricity (AC-powered) device designed to record and interpret a variety of physiologic functions during sleep to evaluate sleep/sleep-related disorders (e.g., insomnia, hypersomnia, apnoea). It typically performs electroencephalography, electrocardiography, electro-oculography, electromyography, and respiration, temperature, and pulse oximetry readings. It may also provide audiovisual information about the sleeping patient for behavioral analysis and other measurements (e.g., gastric reflux, bedwetting). The device includes electrodes, measuring instruments, samplers, filters, amplifiers, and appropriate software for processing data and providing patient diagnoses.
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.
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FDA Product Code

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Sterilization

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Sterilization Method [?]
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Storage and Handling

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Storage and Handling
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Clinically Relevant Size

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Size Type Text
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Device Status

In Commercial Distribution
September 23, 2016

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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Secondary DI

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Unit of Use DI

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Direct Marking (DM)

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Production Identifier(s) in UDI

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Customer Contact

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No Customer Contact currently defined
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