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MUX Interfaced Measurement Adapter

Primary DI
04250413400553
Brand
MUX Interfaced Measurement Adapter
Company
SOMNOmedics AG
Model
SEN658
Published
2019-04-12
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

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MNRVentilatory Effort RecorderAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K071556000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K071556000SOMNOSCREEN EEG10-20Somnomedics GmbH2007-07-18MNR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04250413400553PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04250413400553042504134005534250413400553

GMDN Terms#

Term, Definition table
TermDefinition
Patient monitoring system module, multifunctionA small unit dedicated to the measurement and displays of several physiological parameters, e.g., electrical activity of the heart, respiratory rate, temperature, blood pressure, pulse, and oximetry. The signals are obtained through connected cables/leads/probes. It is designed to operate as part of a patient monitoring system enhancing the function of this system (the parent device). The module automatically plugs into the parent device when the user places it into a standardized slot in the parent device which then operates as a mainframe computer displaying the various parameters/information measured and provided by this module.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
314112173
Device count
1
Lot or batch
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 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
08885021950075TipTraQPRANAQ PTE. LTD.MNR2026-09-25
08885021950105TipTraQPRANAQ PTE. LTD.MNR2026-09-25
04250413410637SOMNOscreen HDSOMNOmedics AGMNR2026-08-13
04250413406388SOMNOwatch™ eco orangeSOMNOmedics AGMNR2026-07-07
04250413405725HomeSleepTestSOMNOmedics AGMNR2026-07-02
04250413405732HomeSleepTest REM+SOMNOmedics AGMNR2026-07-02
08885021950013TipTraQPRANAQ PTE. LTD.MNR2026-05-18
08885021950136TipTraQPRANAQ PTE. LTD.MNR2026-05-18
08720256698296Onera STS 2Onera B.V.MNR2026-05-15
08720256698302Onera STS 2Onera B.V.MNR2026-05-15
08720256698319Onera STS 2Onera B.V.MNR2026-05-15
08720256698326Onera STS 2Onera B.V.MNR2026-05-15
08720256698333Onera STS 2Onera B.V.MNR2026-05-15