FDA.reportPublic FDA data

Noxturnal Web

Primary DI
15694311112075
Brand
Noxturnal Web
Company
Nox Medical ehf.
Model
NOXTURNAL_WEB
Published
2025-06-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
OLVStandard Polysomnograph With Electroencephalograph

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OLVStandard Polysomnograph With ElectroencephalographNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K241288000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K241288000Noxturnal WebNox Medical Ehf2024-12-23OLV

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15694311112075PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1569431111207515694311112075

GMDN Terms#

Term, Definition table
TermDefinition
Sleep disorder interpretive software, professional-onlyAn interpretive software program intended to be used exclusively by healthcare professionals to collect and analyse patient physiological data during sleep and publish reports to assist diagnosis of sleep disorders (e.g., insomnia, sleep apnoea). It is typically used as part of a polysomnography study using a wide range of data of [e.g., electrocardiogram (ECG), electroencephalogram (EEG), haemoglobin oxygen saturation (SpO2), chest wall motion, airflow, eye movement].

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
365741462
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
15694311111887Nox Nasal Pressure Cannula with FilterNOX-MDR_CANAF405520112026-01-28
15694311111894Nox Nasal Pressure Cannula with FilterNOX-MDR_CANAF405520112026-01-28
15694311112112SomrystSOMRYST6510102024-12-30
15694311111672Nox SAS Body Cable - RightESNAP4SASRMPAC1US5622162025-06-06
15694311111689Nox SAS Body Cable - LeftESNAP4SASLMPAC1US5622172025-06-06
15694311111719Nox SAS Head CableESNAP10SASLMPAC1US5622182025-06-06
15694311111191Nox SAS Body Cable - RightESNAP4SASRMPAC1US5622162025-06-06
15694311111207Nox SAS Body Cable - LeftESNAP4SASLMPAC1US5622172025-06-06
15694311111214Nox SAS Head CableESNAP10SASLMPAC1US5622182025-06-06
15694311112099DeepRESPDEEPRESP2025-06-06
15694311110477Nox Mini USB CableNOX-USBCPAC15620112016-09-16
15694311110736QDC-PRO KitNOX-QDCPETL_KIT15140112016-09-16
15694311110354Nox Snap-on Lead, 100 cmNOX-ESNAP11PAC25540282016-09-16
15694311110361Nox Snap-on Double Lead, 50/100 cmNOX-ESNAP1PAC15543102016-09-16
15694311110378Nox Snap-on Double Lead, 30/50 cmNOX-PESNAP1PAC15543112016-09-16
15694311110279Nox Snap-on Lead, 50 cmNOX-ESNAP7PAC25540202016-09-16
15694311110286Nox Snap-on Lead, 30 cmNOX-PESNAP7PAC25540212016-09-16
15694311110316Nox Snap-on Lead, 150 cmNOX-ESNAP9PAC25540242016-09-16
15694311110323Nox Snap-on Lead, 100 cmNOX-PESNAP9PAC25540252016-09-16
15694311110330Nox Snap-on Lead, 150 cmNOX-ESNAP10PAC25540262016-09-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
08720256698296Onera STS 2Onera B.V.OLV2026-05-15
08720256698302Onera STS 2Onera B.V.OLV2026-05-15
08720256698319Onera STS 2Onera B.V.OLV2026-05-15
08720256698326Onera STS 2Onera B.V.OLV2026-05-15
08720256698333Onera STS 2Onera B.V.OLV2026-05-15
08720256698340Onera STS 2Onera B.V.OLV2026-05-15
08720256698357Onera STS 2Onera B.V.OLV2026-05-15
08720256698364Onera STS 2Onera B.V.OLV2026-05-15
08720256698371Onera STS 2Onera B.V.OLV2026-05-15
08720256698463Onera STSOnera B.V.OLV2026-05-15
08720256698487Onera STSOnera B.V.OLV2026-05-15
08720256698494Onera STSOnera B.V.OLV2026-05-15
08720256698500Onera STSOnera B.V.OLV2026-05-15
08720256698517Onera STSOnera B.V.OLV2026-05-15
08720256698524Onera STSOnera B.V.OLV2026-05-15
08720256698531Onera STSOnera B.V.OLV2026-05-15
00850049266055WavebandBeacon Biosignals, Inc.OLV2026-04-17
00850049266062WavebandBeacon Biosignals, Inc.OLV2026-04-17
B566847020ZmachineGeneral SleepOLV2026-04-16
B566847001ZmachineGeneral SleepOLV2026-04-09