FDA.reportPublic FDA data

Sphinx PMU700 Polysomnography Monitoring Unit

Primary DI
00817111020809
Brand
Sphinx PMU700 Polysomnography Monitoring Unit
Company
Neurotronics, LLC
Model
PMU700
Published
2016-09-22
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
DQAOximeter
OLVStandard Polysomnograph With Electroencephalograph
OLZAutomatic Event Detection Software For Polysomnograph With Electroencephalograph

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQAOximeterCardiovascular2
OLVStandard Polysomnograph With ElectroencephalographNeurology2
OLZAutomatic Event Detection Software For Polysomnograph With ElectroencephalographNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817111020809PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817111020809008171110208098171110208090817111020809

GMDN Terms#

Term, Definition table
TermDefinition
PolysomnographA 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
036405363
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817111021288NiteLynx PVDF Effort Sensor1.5mm DIN, 0.6mS203402025-10-10
00817111021295NiteLynx PVDF Effort Sensor1.5mm DIN, 2.0mS829672025-10-10
00817111021301NiteLynx PVDF Effort Sensor249 Keyhole, 0.6mS687292025-10-10
00817111021318NiteLynx PVDF Effort Sensor249 Keyhole, 2.0mS681592025-10-10
00817111021325NiteLynx PVDF Effort SensorDisposable BeltS618152025-10-10
00817111021349NiteLynx PVDF Effort SensorNomadAirS922732025-10-10
00817111021332Polysmith12.32025-09-23
00817111021158Serenity PZ01 Piezo Sensor, 1.5mm DIN, 3.0mPZ01S528972019-05-01
00817111021165Serenity PZ01 Piezo Sensor, 249 Keyhole, 3.0mPZ01S831112019-05-01
00817111020823Serenity BP01 Body Position Sensor, 3.5mm Mono, 2.0mBP01S179262018-11-08
00817111020830Serenity BP01 Body Position Sensor, 1.5mm DIN, 2.0mBP01S297242018-11-08
00817111020847Serenity BP01 Body Position Sensor, 249 Keyhole, 2.0mBP01S407122018-11-08
00817111020854Serenity RIP01 RIP Driver, Abdomen, 1.5mm DIN, 0.6mRIP01S433592018-11-08
00817111020861Serenity RIP01 RIP Driver, Abdomen, 1.5mm DIN, 2.0mRIP01S531072018-11-08
00817111020878Serenity RIP01 RIP Driver, Thorax, 249 Keyhole, 0.6mRIP01S849962018-11-08
00817111020885Serenity RIP01 RIP Driver, Thorax, 249 Keyhole, 2.0mRIP01S330592018-11-08
00817111020892Serenity RIP01 RIP Driver, Abdomen, 249 Keyhole, 2.0mRIP01S734262018-11-08
00817111020908Serenity RIP01 RIP Driver, Abdomen, 249 Keyhole, 0.6mRIP01S391542018-11-08
00817111020915Serenity RIP01 RIP Driver, Thorax, 1.5mm DIN, 0.6mRIP01S556382018-11-08
00817111020922Serenity RIP01 RIP Driver, Thorax, 1.5mm DIN, 2.0mRIP01S215762018-11-08

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Primary DI, Brand, Company table
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