FDA.reportPublic FDA data

LABSYSTEM™ PRO

Primary DI
08714729905721
Brand
LABSYSTEM™ PRO
Company
BOSTON SCIENTIFIC CORPORATION
Model
M004LSPRO160D0
Catalog number
M004LSPRO160D0
Device description
160 Channel Amplifier Kit
Published
2016-09-24
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
DRQAMPLIFIER AND SIGNAL CONDITIONER, TRANSDUCER SIGNAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DRQAmplifier And Signal Conditioner, Transducer SignalCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08714729905721PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08714729905721087147299057218714729905721

GMDN Terms#

Term, Definition table
TermDefinition
Multiple physiological signal amplifierAn electronic device that increases current, voltage, or power to adjust the signal level and impedance between two or more medical devices transmitting physiological signals; or the device has the capability of being used for more than a single application, such as electroencephalography (EEG), evoked potential, polysomnography (sleep analysis) and general polygraphy.

Regulatory Flags#

DUNS number
021717889
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00191506049232Orbera™M00505670M005056702026-06-04
08714729121190Ultraflex™ Esophageal NGM005142002015-09-24
08714729121206Ultraflex™ Esophageal NGM005142102015-09-24
08714729121213Ultraflex™ Esophageal NGM005142202015-09-24
08714729121220Ultraflex™ Esophageal NGM005142302015-09-24
08714729649113Ultraflex™ Esophageal NGM005137502015-09-24
08714729716075Ultraflex™ Esophageal NGM005138502015-09-24
08714729716082Ultraflex™ Esophageal NGM005138602015-09-24
08714729716099Ultraflex™ Esophageal NGM005138402015-09-24
08714729716105Ultraflex™ Esophageal NGM005142402015-09-24
08714729716112Ultraflex™ Esophageal NGM005142502015-09-24
08714729716129Ultraflex™ Esophageal NGM005137002015-09-24
08714729716136Ultraflex™ Esophageal NGM005137102015-09-24
08714729716143Ultraflex™ Esophageal NGM005137202015-09-24
08714729716150Ultraflex™ Esophageal NGM005137302015-09-24
08714729716167Ultraflex™ Esophageal NGM005137402015-09-24
08714729716174Ultraflex™ Esophageal NGM005138002015-09-24
08714729716181Ultraflex™ Esophageal NGM005138102015-09-24
08714729716198Ultraflex™ Esophageal NGM005138202015-09-24
08714729716204Ultraflex™ Esophageal NGM005138302015-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00851725007399Central StationNihon Kohden Digital Health Solutions, LLCDRQ2025-06-30
04931921017159CNS-2101 Central MonitorNIHON KOHDEN CORPORATIONDRQ2023-10-30
04931921017166CNS-2101 Central MonitorNIHON KOHDEN CORPORATIONDRQ2023-10-01
00868924000267Monitor Input Cable, Mikro-Cath to EP-Tracer SystemMILLAR INC.DRQ2021-07-16
00884838093188Avalon Toco+ MP TransducerPhilips Medizin Systeme Böblingen GmbHDRQ2021-03-08
00884838093195Avalon Ultrasound TransducerPhilips Medizin Systeme Böblingen GmbHDRQ2021-03-08
00884838093201Avalon ECG/IUP TransducerPhilips Medizin Systeme Böblingen GmbHDRQ2021-03-08
00884838093218Avalon Toco MP TransducerPhilips Medizin Systeme Böblingen GmbHDRQ2021-03-08
00884838093225Avalon Toco+ TransducerPhilips Medizin Systeme Böblingen GmbHDRQ2021-03-08
08714729882985LABSYSTEM™ PROBOSTON SCIENTIFIC CORPORATIONDRQ2019-12-13
08714729882992LABSYSTEM™ PROBOSTON SCIENTIFIC CORPORATIONDRQ2019-12-13
08714729883234LABSYSTEM™ PROBOSTON SCIENTIFIC CORPORATIONDRQ2019-12-13
08714729883241LABSYSTEM™ PROBOSTON SCIENTIFIC CORPORATIONDRQ2019-12-13
08714729883289LABSYSTEM™ PROBOSTON SCIENTIFIC CORPORATIONDRQ2019-12-13
08714729883296LABSYSTEM™ PROBOSTON SCIENTIFIC CORPORATIONDRQ2019-12-13
08714729883333LABSYSTEM™ PROBOSTON SCIENTIFIC CORPORATIONDRQ2019-12-13
08714729883340LABSYSTEM™ PROBOSTON SCIENTIFIC CORPORATIONDRQ2019-12-13
08714729885825LABSYSTEM™ PROBOSTON SCIENTIFIC CORPORATIONDRQ2019-12-13
08714729885832LABSYSTEM™ PROBOSTON SCIENTIFIC CORPORATIONDRQ2019-12-13
08714729885863LABSYSTEM™ PROBOSTON SCIENTIFIC CORPORATIONDRQ2019-12-13
08714729885870LABSYSTEM™ PROBOSTON SCIENTIFIC CORPORATIONDRQ2019-12-13
08714729885900LABSYSTEM™ PROBOSTON SCIENTIFIC CORPORATIONDRQ2019-12-13
08714729885917LABSYSTEM™ PROBOSTON SCIENTIFIC CORPORATIONDRQ2019-12-13
08714729885955LABSYSTEM™ PROBOSTON SCIENTIFIC CORPORATIONDRQ2019-12-13
08714729885962LABSYSTEM™ PROBOSTON SCIENTIFIC CORPORATIONDRQ2019-12-13
40841716101586ACIST RXi® Mini System OverpackACIST MEDICAL SYSTEMS, INC.DRQ2019-05-06
00884838020849SO2 Optical ModulePhilips Medizin Systeme Böblingen GmbHDRQ2018-12-18
10841716101769ACIST RXi® Mini MountACIST MEDICAL SYSTEMS, INC.DRQ2017-09-27
10841716101783ACIST RXi® Mini Processing UnitACIST MEDICAL SYSTEMS, INC.DRQ2017-09-27
10841716101790ACIST RXi® Mini Navvus InterfaceACIST MEDICAL SYSTEMS, INC.DRQ2017-09-27