FDA.reportPublic FDA data

SOMNOscreen Plus accessory

Primary DI
04250413400522
Brand
SOMNOscreen Plus accessory
Company
SOMNOmedics AG
Model
SEN614O
Published
2023-08-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
MNRVentilatory Effort Recorder
OLVStandard Polysomnograph With Electroencephalograph

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MNRVentilatory Effort RecorderAnesthesiology2
OLVStandard Polysomnograph With ElectroencephalographNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04250413400522PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04250413400522042504134005224250413400522

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
314112173
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
042504134004853-channel ECG ElectrodeSEP6282026-10-09
04250413402380Pneumatic Effort Belt - Size XSSEN6412026-10-09
04250413402397Pneumatic Effort Belt - Size SSEN6422026-10-09
04250413402403Pneumatic Effort Belt - Size MSEN6432026-10-09
04250413402410Pneumatic Effort Belt - Size LSEN6442026-10-09
04250413402427Pneumatic Effort Belt - Size XXLSEN6452026-10-09
04250413407392Sensor kit for SOMNOscreen (paediatric)SEN8002026-10-10
04250413407408Sensor kit for SOMNOscreen (extra small)SEN8012026-10-10
04250413410392Wireless PLM/EMG sensor right legNGS0752026-10-08
04250413401635DOMINO lightSOW1052026-10-07
04250413402861EEG-ElectrodeSEN0072026-10-07
04250413404858SOMNOtouch™ RESP ecoTOR050-E-U2026-10-07
04250413405657ABPMpro SoftwareSW1002026-10-07
04250413405664DOMINOSSC0902026-10-07
04250413410385Wireless PLM/EMG sensor left legNGS0742026-10-07
04250413405725HomeSleepTestHST050U2026-07-02
04250413405732HomeSleepTest REM+HSTR050U2026-07-02
04250413410637SOMNOscreen HDNGD050U2026-08-13
04250413402724SOMNOscreen ecoNGN050U2019-03-15
04250413403578Cuff ABPMpro without ECGABP501/B2026-07-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04250413407392Sensor kit for SOMNOscreen (paediatric)SOMNOmedics AGMNR2026-10-10
04250413407408Sensor kit for SOMNOscreen (extra small)SOMNOmedics AGMNR2026-10-10
04250413402380Pneumatic Effort Belt - Size XSSOMNOmedics AGMNR2026-10-09
04250413402397Pneumatic Effort Belt - Size SSOMNOmedics AGMNR2026-10-09
04250413402403Pneumatic Effort Belt - Size MSOMNOmedics AGMNR2026-10-09
04250413402410Pneumatic Effort Belt - Size LSOMNOmedics AGMNR2026-10-09
04250413402427Pneumatic Effort Belt - Size XXLSOMNOmedics AGMNR2026-10-09
04250413410392Wireless PLM/EMG sensor right legSOMNOmedics AGMNR2026-10-08
04250413401635DOMINO lightSOMNOmedics AGMNR2026-10-07
04250413402861EEG-ElectrodeSOMNOmedics AGOLV2026-10-07
04250413402861EEG-ElectrodeSOMNOmedics AGMNR2026-10-07
04250413404858SOMNOtouch™ RESP ecoSOMNOmedics AGMNR2026-10-07
04250413405664DOMINOSOMNOmedics AGMNR2026-10-07
04250413410385Wireless PLM/EMG sensor left legSOMNOmedics AGMNR2026-10-07
00850063034395Night ShiftADVANCED BRAIN MONITORING, INC.MNR2026-10-05
00850063034500Night ShiftADVANCED BRAIN MONITORING, INC.MNR2026-10-05
00850063034517Night ShiftADVANCED BRAIN MONITORING, INC.MNR2026-10-05
00860000272421Rhythm ExpressVIVAQUANT, INC.MNR2026-10-01
00850063034401Sleep Profiler PSG2ADVANCED BRAIN MONITORING, INC.OLV2026-09-25
00850063034418Sleep Profiler PSG2ADVANCED BRAIN MONITORING, INC.OLV2026-09-25
00850063034425Sleep ProfilerADVANCED BRAIN MONITORING, INC.OLV2026-09-25
00850063034432Sleep ProfilerADVANCED BRAIN MONITORING, INC.OLV2026-09-25
00850063034449Sleep ProfilerADVANCED BRAIN MONITORING, INC.OLV2026-09-25
00850063034456Sleep ProfilerADVANCED BRAIN MONITORING, INC.OLV2026-09-25
00850063034470Sleep ProfilerADVANCED BRAIN MONITORING, INC.OLV2026-09-25
00850063034487Sleep ProfilerADVANCED BRAIN MONITORING, INC.OLV2026-09-25
00850063034494Sleep ProfilerADVANCED BRAIN MONITORING, INC.OLV2026-09-25
00850063034524Sleep ProfilerADVANCED BRAIN MONITORING, INC.OLV2026-09-25
08885021950075TipTraQPRANAQ PTE. LTD.MNR2026-09-25
08885021950105TipTraQPRANAQ PTE. LTD.MNR2026-09-25