FDA.reportPublic FDA data

NeuroSENSE

Primary DI
B746NS90101
Brand
NeuroSENSE
Company
Neurowave Systems Inc.
Model
NS-901
Published
2022-10-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Product Codes#

Code, Name table
CodeName
OLWIndex-Generating Electroencephalograph Software

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OLWIndex-Generating Electroencephalograph SoftwareNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B746NS90101PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Anaesthesia depth monitorA mains electricity (AC-powered) device intended to be used to detect, process, and display the signals recorded from an unconscious patient (in a state of anaesthesia), showing the degree of consciousness. It is based upon the bispectral index (BIS) analysis of the electroencephalogram waveform and other features of this, enabling detection of, e.g., levels of sedation, loss of consciousness, and recall. It is used during anaesthesia administration and in trauma.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
607075160
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B746EK9011EasyPrep Sensor KitEK-901EK-9012023-11-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840682147811CARESCAPE SoftwareGE Healthcare Finland OyOLW2026-04-15
00690103219395Smart Pressure ControllerEdwards Lifesciences LLCOLW2025-09-10
00690103219531Acumen IQ PlusEdwards Lifesciences LLCOLW2025-09-10
00690103219609VitaWaveEdwards Lifesciences LLCOLW2025-09-10
10841522108754UltraviewSLSPACELABS HEALTHCARE (WASHINGTON), INCOLW2024-05-13
10884521808270BISCovidien LPOLW2024-04-28
10884521808300BISCovidien LPOLW2024-04-28
10884521808317BISCovidien LPOLW2024-04-28
10884521533103BISCovidien LPOLW2024-03-01
00690103218848HemoSphere VitaEdwards Lifesciences LLCOLW2024-02-26
00690103218855HemoSphere VitaEdwards Lifesciences LLCOLW2024-02-26
10843997012802RD SedlineMASIMO CORPORATIONOLW2023-08-22
00843997013475SedLineMASIMO CORPORATIONOLW2023-08-22
00843997013895SedLineMASIMO CORPORATIONOLW2023-08-22
00843997012805RD SedlineMASIMO CORPORATIONOLW2023-08-22
00195278522313CARESCAPE Canvas Smart DisplayGE Healthcare Finland OyOLW2023-04-19
00195278522320CARESCAPE Canvas 1000GE Healthcare Finland OyOLW2023-04-19
00195278523365CARESCAPE Canvas D19GE Healthcare Finland OyOLW2023-04-19
00195278524089NAGE Healthcare Finland OyOLW2023-04-19
10884521713055BISCovidien LPOLW2023-01-21
10884521812376BISCovidien LPOLW2022-09-24
00840682146111CARESCAPE B650GE Healthcare Finland OyOLW2022-05-13
00840682146135CARESCAPE B450GE Healthcare Finland OyOLW2022-05-13
00840682146142CARESCAPE B850GE Healthcare Finland OyOLW2022-05-13
00840682146708NAGE Medical Systems Information Technologies, Inc.OLW2022-04-12
00840682146715NAGE Medical Systems Information Technologies, Inc.OLW2022-04-12
00840682146791NAGE Medical Systems Information Technologies, Inc.OLW2022-04-12
00840682147217NAGE Medical Systems Information Technologies, Inc.OLW2022-04-12
00840682147224NAGE Medical Systems Information Technologies, Inc.OLW2022-04-12
10884521533066BISCovidien LPOLW2021-12-24