DeltaScan Monitor

Primary DI
08719326465395
Brand
DeltaScan Monitor
Company
Prolira B.V.
Model
R2
Catalog number
006.000.A
Published
2023-05-11
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
NCGNeuropsychiatric Interpretative Electroencephalograph Assessment Aid

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NCGNeuropsychiatric Interpretative Electroencephalograph Assessment AidNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08719326465395PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08719326465395087193264653958719326465395

GMDN Terms#

Term, Definition table
TermDefinition
Electroencephalographic monitoring systemAn electrically-powered device assembly designed to continuously measure the electrical signals produced by a patient's brain and display/record them as an electroencephalogram (EEG) to evaluate brain function, typically in an examination room or intensive care unit (ICU) [bedside]; it may also monitor additional physiological parameters [e.g., electromyogram (EMG), respiration wave forms, blood pressure, haemoglobin oxygen saturation (SpO2)] in relation to EEG. It typically includes a control unit, electrodes, and components (e.g., amplifier, cables, probes). It may include data interpretation and/or telemetry features.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
491559325
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08719326465340DeltaScan PatchR2009.000.B2023-05-11
87193264653408DeltaScan PatchR2009.000.B2023-05-11
87193264653958DeltaScan MonitorR2006.000.A2023-05-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
87193264653958DeltaScan MonitorProlira B.V.NCG2023-05-11
00863414000314NEBA Compact EEG SystemNEBA HEALTH, LLCNCG2016-10-03