FDA.reportPublic FDA data

LABSYSTEM™ PRO

Primary DI
08714729885870
Brand
LABSYSTEM™ PRO
Company
BOSTON SCIENTIFIC CORPORATION
Model
M0042002022H0
Catalog number
M0042002022H0
Device description
CLEARSIGN™ II Amplifier For LABSYSTEM™ PRO EP Recording System, 80 Channels
Published
2019-12-13
Public version status
New
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
08714729885870PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08714729885870087147298858708714729885870

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.

Sterilization Methods#

Method table
Method

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
08714729142201EndoVive Low Profile Replacement ButtonM005627702016-09-24
08714729142218EndoVive Low Profile Replacement ButtonM005628302016-09-24
08714729149200EndoVive™ One Step Button™M00568450M005684502018-09-07
08714729149217EndoVive™ One Step Button™M00568470M005684702018-09-07
08714729149224EndoVive™ One Step Button™M00568500M005685002018-09-07
08714729149231EndoVive™ One Step Button™M00568520M005685202018-09-07
08714729149934EndoVive™ One Step Button™M00568480M005684802018-09-07
08714729149941EndoVive™ One Step Button™M00568530M005685302018-09-07
08714729150084EndoVive™ One Step Button™M00568460M005684602018-09-07
08714729151081EndoVive™ One Step Button™M00568510M005685102018-09-07
08714729284017EndoVive Low Profile Replacement ButtonM005627602016-09-24
08714729284024EndoVive Low Profile Replacement ButtonM005627802016-09-24
08714729284031EndoVive Low Profile Replacement ButtonM005627902016-09-24
08714729284048EndoVive Low Profile Replacement ButtonM005628002016-09-24
08714729284062EndoVive Low Profile Replacement ButtonM005628202016-09-24
08714729284079EndoVive Low Profile Replacement ButtonM005628402016-09-24
08714729284086EndoVive Low Profile Replacement ButtonM005628502016-09-24
08714729821717Radial Jaw 4M005151802016-09-24
08714729821731Radial Jaw 4M005151902016-09-24
08714729821748Radial Jaw 4M005152002016-09-24

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
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
30841716101770RXi® Mini Navvus Interface CableACIST MEDICAL SYSTEMS, INC.DRQ2017-09-27