FDA.reportPublic FDA data

LABSYSTEM™ PRO

Primary DI
08714729882961
Brand
LABSYSTEM™ PRO
Company
BOSTON SCIENTIFIC CORPORATION
Model
M00420012300
Device description
RF Filter Module For CLEARSIGN™ Amplifier
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
08714729882961PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08714729882961087147298829618714729882961

GMDN Terms#

Term, Definition table
TermDefinition
Electronic signal frequency filterAn electronic filter that transfers electronic signals at all frequencies within a certain area, and suppresses signals at all other frequencies outside this area. This GMDN code also includes octave and third-octave filters.

Sterilization Methods#

Method table
Method

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08714729972860LumiCoil™M005538302018-02-15
08714729972884LumiCoil™M005538402018-02-15
08714729842088Rhythmia™ Mapping SystemM004RH200002017-06-14
08714729842095Rhythmia™ Mapping SystemM004RH210002017-06-14
08714729842101Rhythmia™ Mapping SystemM004RH220002017-06-14
08714729880318Rhythmia™ Mapping SystemM004RBLMR1002016-09-24
08714729938736RHYTHMIA HDx™M004RH20010M004RH200102017-05-03
08714729832089Rubicon™ 18H749392390180902016-09-24
08714729832096Rubicon™ 35H749392400350902016-09-24
08714729832102Rubicon™ 35H749392400351502016-09-24
08714729832119Rubicon™ 35H749392400350602016-09-24
08714729832126Rubicon™ 35H749392400351302016-09-24
08714729832133Rubicon™ 14H749392120141302016-09-24
08714729832140Rubicon™ 14H749392120141502016-09-24
08714729832157Rubicon™ 18H749392390181302016-09-24
08714729832164Rubicon™ 18H749392390181502016-09-24
00191506019563Rubicon™ ControlH749394321409A0H749394321409A02024-02-16
00191506019587Rubicon™ ControlH749394321413A0H749394321413A02024-02-16
00191506019600Rubicon™ ControlH749394321415A0H749394321415A02024-02-16
00191506019624Rubicon™ ControlH749394321809A0H749394321809A02024-02-16

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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
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08714729883289LABSYSTEM™ PROBOSTON SCIENTIFIC CORPORATIONDRQ2019-12-13
08714729883296LABSYSTEM™ PROBOSTON SCIENTIFIC CORPORATIONDRQ2019-12-13
08714729883333LABSYSTEM™ PROBOSTON SCIENTIFIC CORPORATIONDRQ2019-12-13
08714729883340LABSYSTEM™ PROBOSTON SCIENTIFIC CORPORATIONDRQ2019-12-13
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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
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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