FDA.reportPublic FDA data

TriplePlay

Primary DI
00817377021985
Brand
TriplePlay
Company
DYMEDIX DIAGNOSTICS, INC.
Model
12-10176-0001
Device description
Interface Cable, NOX-T3
Published
2018-10-05
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
MNRVentilatory Effort Recorder

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MNRVentilatory Effort RecorderAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K990321000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K990321000ALPHAMED GEMINI SENSOR, SNORING SENSORAlphamed, Inc.1999-06-01MNR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817377021985PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817377021985008173770219858173770219850817377021985

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
079976463
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817377022791SnuggleFit11-15000-00102021-07-21
00817377023002Perfect Fit11-44100-75012021-07-21
00817377023019Perfect Fit11-44200-75012021-07-21
00817377023026Perfect Fit11-44300-75022021-07-21
00817377021855Perfect Fit11-42307-06012021-07-21
00817377021862Perfect Fit11-42407-06012021-07-21
00817377022494Perfect Fit11-14001-10012021-07-21
00817377022500SnuggleFit11-14002-10012021-07-21
00817377022517SnuggleFit11-14002-50012021-07-21
00817377022531SnuggleFit18-13300-00012021-07-21
00817377022548SnuggleFit18-13301-00012021-07-21
00817377022555SnuggleFit18-13302-00012021-07-21
00817377022562SnuggleFit18-13304-00012021-07-21
00817377022579SnuggleFit18-13305-00012021-07-21
00817377022586SnuggleFit18-13310-00012021-07-21
00817377022807SnuggleFit11-15000-00102021-07-21
00817377022944Perfect Fit11-42710-06012021-07-21
00817377022951Perfect Fit11-42810-06012021-07-21
00817377022975Perfect Fit11-94320-06012021-07-21
00817377022982Perfect Fit11-94321-06012021-07-21

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
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
08720256698340Onera STS 2Onera B.V.MNR2026-05-15
08720256698357Onera STS 2Onera B.V.MNR2026-05-15
08720256698364Onera STS 2Onera B.V.MNR2026-05-15
08720256698371Onera STS 2Onera B.V.MNR2026-05-15
08720256698463Onera STSOnera B.V.MNR2026-05-15
08720256698487Onera STSOnera B.V.MNR2026-05-15
08720256698494Onera STSOnera B.V.MNR2026-05-15
08720256698500Onera STSOnera B.V.MNR2026-05-15
08720256698517Onera STSOnera B.V.MNR2026-05-15
08720256698524Onera STSOnera B.V.MNR2026-05-15
08720256698531Onera STSOnera B.V.MNR2026-05-15
08885021950044TipTraQPRANAQ PTE. LTD.MNR2026-05-15
08885021950051TipTraQPRANAQ PTE. LTD.MNR2026-05-11
B566847001ZmachineGeneral SleepMNR2026-04-09
B566847002ZmachineGeneral SleepMNR2026-04-09
09342451002655Compumedics SomfitCOMPUMEDICS LIMITEDMNR2026-03-12
09342451002662Compumedics SomfitCOMPUMEDICS LIMITEDMNR2026-03-12
09342451002747Compumedics FalconCOMPUMEDICS LIMITEDMNR2026-03-12
09342451002754Compumedics FalconCOMPUMEDICS LIMITEDMNR2026-03-12
09342451002785Compumedics FalconCOMPUMEDICS LIMITEDMNR2026-03-12
09342451002822Compumedics SomfitCOMPUMEDICS LIMITEDMNR2026-03-12
09342451002860Compumedics SomfitCOMPUMEDICS LIMITEDMNR2026-03-12
09342451007063Compumedics Somfit DCOMPUMEDICS LIMITEDMNR2026-03-12