DeltaScan Monitor

Primary DI
87193264653958
Brand
DeltaScan Monitor
Company
Prolira B.V.
Model
R2
Catalog number
006.000.A
Published
2023-05-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
87193264653958PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
8719326465395887193264653958

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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08719326465340DeltaScan PatchR2009.000.B2023-05-11
08719326465395DeltaScan MonitorR2006.000.A2023-05-11
87193264653408DeltaScan PatchR2009.000.B2023-05-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08719326465395DeltaScan MonitorProlira B.V.NCG2023-05-11
00863414000314NEBA Compact EEG SystemNEBA HEALTH, LLCNCG2016-10-03