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
00191506041656FARASTAR™M004PF41M434M004PF41M4342024-02-14
00191506041663FARASTAR™M004PF41M444M004PF41M4442024-02-09
08714729796695Alair Bronchial Thermoplasty RF ControllerATS 200M005ATS200002014-09-24
08714729802822Alair Bronchial Thermoplasty RF ControllerATS 200M005ATS200R02014-09-24
08714729961154Alair Bronchial Thermoplasty RF ControllerATS 200M005ATS200RR02017-08-07
08714729424246Contour™M0061802311202015-09-24
08714729457923Percuflex™M0061453600502015-09-24
08714729460282Percuflex™ PlusM0061751980602015-09-24
08714729460398Percuflex™ PlusM0061752500602015-09-24
08714729460657Percuflex™ PlusM0061752600502015-09-24
08714729461012Percuflex™ PlusM0061752650602015-09-24
08714729766629Polaris™ UltraM0061921401902015-09-24
08714729766735Polaris™ UltraM0061921441702015-09-24
08714729766759Polaris™ UltraM0061921451202015-09-24
08714729766766Polaris™ UltraM0061921451702015-09-24
08714729766803Polaris™ UltraM0061921501902015-09-24
08714729766841Polaris™ UltraM0061921521202015-09-24
08714729766919Polaris™ UltraM0061921541702015-09-24
08714729766926Polaris™ UltraM0061921541902015-09-24
08714729776307Contour™M0061802351702015-09-24

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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
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08714729883289LABSYSTEM™ PROBOSTON SCIENTIFIC CORPORATIONDRQ2019-12-13
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