DEVICE: SOMNOscreen plus PSG+ AASM Set (04250413401932)

Device Identifier (DI) Information

SOMNOscreen plus PSG+ AASM Set
SSP201AU
In Commercial Distribution
SSP201AU
SOMNOmedics GmbH
04250413401932
GS1

1
314112173 *Terms of Use
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© 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?
13085 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").
Active false
47567 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.
Active false
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

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Product Code Product Code Name
No Product Codes
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
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Sterilization

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Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

2376de97-192e-475b-b428-21f213e88e0a
September 05, 2018
3
September 23, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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No Package DIs found
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Secondary DI

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

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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None
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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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