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
04250413402748SOMNOwatch plus ACTISOWP100Z2023-12-07
04250413402755SOMNOwatch plus ACTISOWP200Z2023-12-07
04250413401475SOMNOwatch plus ACTISOWP2002019-04-12
04250413401666SOMNOwatch plus Docking StationSOW1062019-04-12
04250413410705Set for wireless PLM measurementNGA1132019-08-13
042504134107121 channel ECG sensor including body position and disposable electrodesNGS091S2019-08-13
04250413405640ABPM pro basic deviceABP050U2024-05-08
04250413410781SOMNO HD / ECO accessoryNGA3102023-11-30
04250413410828SOMNOscreen ECO EEG 32NGN740U 2023-11-30
04250413410835SOMNOtouch RESP accessoryTOS110S2023-11-30
04250413410842SOMNOtouch RESP accessoryTOS175S2023-11-30
04250413410859SOMNOtouch RESP accessoryTOS011S2023-11-30
04250413400607SOMNOscreen Plus accessorySEN6132023-08-25
04250413400614SOMNOscreen Plus accessorySEN6142023-08-25
00833166000405SOMNOscreen plus AccessorySEN2092017-05-22
00833166000412SOMNOscreen plus AccessorySEN2152017-05-22
04250413400362Microphone for Snoring detectionSEN6022019-04-12
04250413400386Activity Sensor for Sleep/Wake detectionSEN6202019-04-12
042504134004161-channel ECG ElectrodeSEN6272019-04-12
04250413400461Effort Sensor SEN6402019-04-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08885021950013TipTraQPRANAQ PTE. LTD.MNR2026-05-18
08885021950136TipTraQPRANAQ PTE. LTD.MNR2026-05-18
08720256698296Onera STS 2Onera B.V.MNR2026-05-15
08720256698296Onera STS 2Onera B.V.OLV2026-05-15
08720256698302Onera STS 2Onera B.V.MNR2026-05-15
08720256698302Onera STS 2Onera B.V.OLV2026-05-15
08720256698319Onera STS 2Onera B.V.OLV2026-05-15
08720256698319Onera STS 2Onera B.V.MNR2026-05-15
08720256698326Onera STS 2Onera B.V.MNR2026-05-15
08720256698326Onera STS 2Onera B.V.OLV2026-05-15
08720256698333Onera STS 2Onera B.V.MNR2026-05-15
08720256698333Onera STS 2Onera B.V.OLV2026-05-15
08720256698340Onera STS 2Onera B.V.OLV2026-05-15
08720256698340Onera STS 2Onera B.V.MNR2026-05-15
08720256698357Onera STS 2Onera B.V.MNR2026-05-15
08720256698357Onera STS 2Onera B.V.OLV2026-05-15
08720256698364Onera STS 2Onera B.V.MNR2026-05-15
08720256698364Onera STS 2Onera B.V.OLV2026-05-15
08720256698371Onera STS 2Onera B.V.MNR2026-05-15
08720256698371Onera STS 2Onera B.V.OLV2026-05-15
08720256698463Onera STSOnera B.V.MNR2026-05-15
08720256698463Onera STSOnera B.V.OLV2026-05-15
08720256698487Onera STSOnera B.V.MNR2026-05-15
08720256698487Onera STSOnera B.V.OLV2026-05-15
08720256698494Onera STSOnera B.V.MNR2026-05-15
08720256698494Onera STSOnera B.V.OLV2026-05-15
08720256698500Onera STSOnera B.V.MNR2026-05-15
08720256698500Onera STSOnera B.V.OLV2026-05-15
08720256698517Onera STSOnera B.V.MNR2026-05-15
08720256698517Onera STSOnera B.V.OLV2026-05-15