FDA.reportPublic FDA data

LABSYSTEM™ PRO

Primary DI
08714729884002
Brand
LABSYSTEM™ PRO
Company
BOSTON SCIENTIFIC CORPORATION
Model
M00420020300
Device description
LABSYSTEM™ PRO EP Review Workstation Software, V2.7
Published
2018-05-23
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
OUGMedical device data system

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OUGMedical Device Data SystemGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08714729884002PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08714729884002087147298840028714729884002

GMDN Terms#

Term, Definition table
TermDefinition
Cardiac electrophysiology processing softwareA software program designed to add specific image processing and/or data analysis capabilities to a computer for the interpretation and/or screening of cardiac electrophysiology parameters [e.g., electrocardiogram (ECG)]. It is intended for use exclusively by healthcare professionals and may provide risk assessment for cardiac events [e.g., acute myocardial infarction (AMI), acute myocardial ischemic injury (AMII)] or screen for specific conditions (e.g., low ejection fraction). It might include artificial intelligence (AI) and machine learning (ML) technology.

Sterilization Methods#

Method table
Method

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
08714729776680Contour™M0061802301802015-09-24
08714729777137Polaris™ UltraM0061921401802015-09-24
08714729777199Polaris™ UltraM0061921501802015-09-24
08714729777205Polaris™ UltraM0061921511802015-09-24
08714729777441Polaris™ LoopM0061552250902015-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10884521856271Touch SurgeryCovidien LPOUG2026-10-16
06945087500262MediWorksSHANGHAI MEDIWORKS PRECISION INSTRUMENTS CO.,LTD.OUG2026-10-09
06945087500439EssilorSHANGHAI MEDIWORKS PRECISION INSTRUMENTS CO.,LTD.OUG2026-10-09
00850015699191Cloud Data Management PlatformCanary Medical USA LLCOUG2026-10-08
04580826921209PENTAX MedicalPENTAX MEDICAL CORPORATIONOUG2026-08-25
00850015699160Canary Flight PlanCanary Medical USA LLCOUG2026-08-07
00850015699177Canary Recovery CurveCanary Medical USA LLCOUG2026-08-07
04048675544227Connectivity Converter CC300Drägerwerk AG & Co. KGaAOUG2026-07-17
04260658860258myoncareONCARE GmbHOUG2026-07-17
00840241600443Kestra Provided Device Patient ApplicationKestra Medical Technologies, Inc.OUG2026-07-16
00884400004871GoClinicMonitored Therapeutics, Inc.OUG2026-07-16
00884400085481GoMobileMonitored Therapeutics, Inc.OUG2026-07-16
04035479194192PatientApp 2.10.0BIOTRONIK SE & Co. KGOUG2026-07-16
00884838132337Care AssistPhilips Medizin Systeme Böblingen GmbHOUG2026-07-13
00884838132344Care AssistPhilips Medizin Systeme Böblingen GmbHOUG2026-07-13
04048675558552Vista GatewayShanghai Draeger Medical Instrument Co.,Ltd.OUG2026-07-13
04048675558569Vista GatewayShanghai Draeger Medical Instrument Co.,Ltd.OUG2026-07-13
04048675558576Vista GatewayShanghai Draeger Medical Instrument Co.,Ltd.OUG2026-07-13
04048675663997Vista GatewayShanghai Draeger Medical Instrument Co.,Ltd.OUG2026-07-13
00199150021277NAMEDTRONIC, INC.OUG2026-05-02
00199150042784NAMEDTRONIC, INC.OUG2026-04-30
00199874112060CliniSphereMonitored Therapeutics, Inc.OUG2026-04-28
00199150002191N/AMEDTRONIC, INC.OUG2026-04-02
00840241600412Kestra Provided Device Patient ApplicationKestra Medical Technologies, Inc.OUG2026-02-04
07613327632811MaistroSTRYKER CORPORATIONOUG2025-10-10
00763000191887N/AMEDTRONIC, INC.OUG2025-09-05
00763000292102N/AMEDTRONIC, INC.OUG2025-09-05
00841492105671ResponderRAULAND-BORG CORPORATIONOUG2025-06-24
00841492105688ResponderRAULAND-BORG CORPORATIONOUG2025-06-24
00841492105695ResponderRAULAND-BORG CORPORATIONOUG2025-06-24