FDA.reportPublic FDA data

Neurovirtual

Primary DI
00850008393211
Brand
Neurovirtual
Company
NEUROVIRTUAL USA, INC.
Model
BWIII PSG Plus
Catalog number
PV2009
Device description
Polysomnograph and Electroencephalograph BWIII PSG Plus
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
GWQFull-Montage Standard Electroencephalograph
OLVStandard Polysomnograph With Electroencephalograph

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GWQFull-Montage Standard ElectroencephalographNeurology2
OLVStandard Polysomnograph With ElectroencephalographNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K112107000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K112107000BWIII EEG, BWIII EEG PLUS, BWIII PSG, BWIII PSG PLUSNeurovirtual USA, Inc.2011-10-28GWQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850008393211PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850008393211008500083932118500083932110850008393211

GMDN Terms#

Term, Definition table
TermDefinition
ElectroencephalographA line-powered device used to record the variations of the electrical potential caused by the electrical activity of the brain, usually detected at the patient's scalp. Leads affixed to the scalp and ear lobes transmit the electric signals to the recorder, which in turn reproduces their characteristics in an electroencephalogram (EEG). They are used to study a variety of neurological conditions, evaluate psychiatric disorders and assist in localizing tumours or lesions on or near the surface of the brain.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure70 KiloPascal102 KiloPascal
Handling Environment Humidity20 Percent (%) Relative Humidity80 Percent (%) Relative Humidity
Handling Environment Temperature0 Degrees Celsius40 Degrees Celsius
Storage Environment Atmospheric Pressure70 KiloPascal102 KiloPascal
Storage Environment Humidity20 Percent (%) Relative Humidity80 Percent (%) Relative Humidity
Storage Environment Temperature-40 Degrees Celsius65 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
791140622
Device count
1
Serial number
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

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