FDA.reportPublic FDA data

Polysmith Version 12.2

Primary DI
00817111021257
Brand
Polysmith Version 12.2
Company
Neurotronics, LLC
Model
12.2
Published
2022-12-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
DQAOximeter
GWLAmplifier, Physiological Signal
MLOElectrocardiograph, Ambulatory, With Analysis Algorithm
MNRVentilatory Effort Recorder
OLVStandard Polysomnograph With Electroencephalograph
OLZAutomatic Event Detection Software For Polysomnograph With Electroencephalograph

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQAOximeterCardiovascular2
GWLAmplifier, Physiological SignalNeurology2
MLOElectrocardiograph, Ambulatory, With Analysis AlgorithmCardiovascular2
MNRVentilatory Effort RecorderAnesthesiology2
OLVStandard Polysomnograph With ElectroencephalographNeurology2
OLZAutomatic Event Detection Software For Polysomnograph With ElectroencephalographNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K062943000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K062943000POLYSMITH SLEEP SYSTEM, MODEL NTI5498Neurotronics, Inc.2007-05-09OLZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817111021257PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817111021257008171110212578171110212570817111021257

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
036405363
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817111021288NiteLynx PVDF Effort Sensor1.5mm DIN, 0.6mS203402025-10-10
00817111021295NiteLynx PVDF Effort Sensor1.5mm DIN, 2.0mS829672025-10-10
00817111021301NiteLynx PVDF Effort Sensor249 Keyhole, 0.6mS687292025-10-10
00817111021318NiteLynx PVDF Effort Sensor249 Keyhole, 2.0mS681592025-10-10
00817111021325NiteLynx PVDF Effort SensorDisposable BeltS618152025-10-10
00817111021349NiteLynx PVDF Effort SensorNomadAirS922732025-10-10
00817111021332Polysmith12.32025-09-23
00817111021158Serenity PZ01 Piezo Sensor, 1.5mm DIN, 3.0mPZ01S528972019-05-01
00817111021165Serenity PZ01 Piezo Sensor, 249 Keyhole, 3.0mPZ01S831112019-05-01
00817111020823Serenity BP01 Body Position Sensor, 3.5mm Mono, 2.0mBP01S179262018-11-08
00817111020830Serenity BP01 Body Position Sensor, 1.5mm DIN, 2.0mBP01S297242018-11-08
00817111020847Serenity BP01 Body Position Sensor, 249 Keyhole, 2.0mBP01S407122018-11-08
00817111020854Serenity RIP01 RIP Driver, Abdomen, 1.5mm DIN, 0.6mRIP01S433592018-11-08
00817111020861Serenity RIP01 RIP Driver, Abdomen, 1.5mm DIN, 2.0mRIP01S531072018-11-08
00817111020878Serenity RIP01 RIP Driver, Thorax, 249 Keyhole, 0.6mRIP01S849962018-11-08
00817111020885Serenity RIP01 RIP Driver, Thorax, 249 Keyhole, 2.0mRIP01S330592018-11-08
00817111020892Serenity RIP01 RIP Driver, Abdomen, 249 Keyhole, 2.0mRIP01S734262018-11-08
00817111020908Serenity RIP01 RIP Driver, Abdomen, 249 Keyhole, 0.6mRIP01S391542018-11-08
00817111020915Serenity RIP01 RIP Driver, Thorax, 1.5mm DIN, 0.6mRIP01S556382018-11-08
00817111020922Serenity RIP01 RIP Driver, Thorax, 1.5mm DIN, 2.0mRIP01S215762018-11-08

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