FDA.reportPublic FDA data

Neurovirtual

Primary DI
00850008393129
Brand
Neurovirtual
Company
NEUROVIRTUAL USA, INC.
Model
Maxxi RIP Thorax Interface 3ft
Catalog number
SI2125
Device description
Maxxi Rip Thorax Interface 3ft is a device intended to capture respiratory effort from a patient and output the signal to a PSG device for sleep studies.
Published
2019-11-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
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
K171304000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K171304000Maxxi Rip SensorNeurovirtual USA, Inc.2019-06-24MNR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850008393129PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850008393129008500083931298500083931290850008393129

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity5 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Handling Environment Temperature5 Degrees Celsius40 Degrees Celsius
Handling Environment Temperature40 Degrees Fahrenheit104 Degrees Fahrenheit
Storage Environment Humidity5 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius60 Degrees Celsius
Storage Environment Temperature-4 Degrees Fahrenheit140 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
791140622
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850008393358Neurovirtual"Maxxi Gold AgCl Electrode 60"" Reusable"SI21372022-02-01
00850008393365Neurovirtual"Maxxi Gold AgCl Electrode 96"""SI21382022-02-01
00850008393303Neurovirtual"Maxxi Gold AgCl Electrode 60"""SI20362020-08-10
00850008393310Neurovirtual"Maxxi Gold AgCl Electrode 96"""SI20372020-08-10
00867975000295Neurovirtual"Maxxi Gold Electrode 60"""PV1010-13CI2019-11-26
00850008393006Neurovirtual"Maxxi Gold Electrode 96"""PV1010-23CI2019-11-26
00850008393013Neurovirtual"Maxxi Gold Snap Electrode 96"""SI18782019-11-26
00850008393020Neurovirtual"Maxxi Gold Snap Electrode 60"""SI18732019-11-26
00850008393037Neurovirtual"Maxxi Gold Snap Electrode 48"""SI18722019-11-26
00850008393044Neurovirtual"Maxxi Gold Electrode 48"""PV1010-33CI2019-11-26
00850008393228NeurovirtualBWMini PSGPV23112019-11-26
00850008393235NeurovirtualBWMini EEGPV23102019-11-26
00850008393242NeurovirtualBWMini HSTPV23122019-11-26
00850008393259NeurovirtualBWMini HST CompassSI18422019-11-26
00850008393372NeurovirtualMaxxi Cannula 2ft Adult NasalSI11952023-03-03
00850008393389NeurovirtualMaxxi Cannula 7ft Adult NasalSI10582023-03-03
00850008393396NeurovirtualMaxxi Cannula 7ft Adult NasalSI10572023-03-03
00850008393174NeurovirtualBWIII BasicsPV20102019-11-26
00850008393181NeurovirtualBWIII EEGPV20062019-11-26
00850008393198NeurovirtualBWIII EEG PlusPV20072019-11-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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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
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04250413405664DOMINOSOMNOmedics AGMNR2026-10-07
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04250413406388SOMNOwatch™ eco orangeSOMNOmedics AGMNR2026-07-07
04250413405725HomeSleepTestSOMNOmedics AGMNR2026-07-02
04250413405732HomeSleepTest REM+SOMNOmedics AGMNR2026-07-02
08885021950013TipTraQPRANAQ PTE. LTD.MNR2026-05-18
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