| Primary Device ID | 08714729882961 | 
| NIH Device Record Key | 663de6db-6d8e-400f-82b1-a25735deb8bc | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | LABSYSTEM™ PRO | 
| Version Model Number | M00420012300 | 
| Company DUNS | 021717889 | 
| Company Name | BOSTON SCIENTIFIC CORPORATION | 
| Device Count | 1 | 
| DM Exempt | false | 
| Pre-market Exempt | false | 
| MRI Safety Status | Labeling does not contain MRI Safety Information | 
| Human Cell/Tissue Product | false | 
| Device Kit | false | 
| Device Combination Product | false | 
| Single Use | false | 
| Lot Batch | true | 
| Serial Number | false | 
| Manufacturing Date | true | 
| Expiration Date | false | 
| Donation Id Number | false | 
| Contains Natural Rubber Latex | false | 
| Labeled No Natural Rubber Latex | false | 
| RX Perscription | true | 
| OTC Over-The-Counter | false | 
| Device Issuing Agency | Device ID | 
|---|---|
| GS1 | 08714729882961 [Primary] | 
| DRQ | AMPLIFIER AND SIGNAL CONDITIONER, TRANSDUCER SIGNAL | 
| Steralize Prior To Use | false | 
| Device Is Sterile | false | 
| Public Version Status | Update | 
| Device Record Status | Published | 
| Public Version Number | 3 | 
| Public Version Date | 2019-10-24 | 
| Device Publish Date | 2016-09-24 | 
| 08714729884101 | Blood Pressure Cable for CLEARSIGN™ Amplifier | 
| 08714729884033 | ECG Leadwire Set For CLEARSIGN™ Amplifier | 
| 08714729883838 | CLEARSIGN™ Amplifier to CARTO® 3 System Quick Connect ECG Cable | 
| 08714729883814 | CLEARSIGN™ Amplifier to CARTO® 3 System Quick Connect Intracardiac Cable | 
| 08714729883784 | CLEARSIGN™ Amplifier to CARTO® 3 System Quick Connect Stimulator Adaptor Cable | 
| 08714729883777 | CLEARSIGN™ Amplifier to CARTO® 3 System Quick Connect Intracardiac Cable | 
| 08714729883753 | CLEARSIGN™ Amplifier to CARTO® 3 System Quick Connect ECG Cable | 
| 08714729883470 | 12 Lead (IEC) ECG Cable For CLEARSIGN™ Amplifier | 
| 08714729883463 | 12 Lead (IEC) ECG Cable For CLEARSIGN™ Amplifier | 
| 08714729883456 | 12 Lead (IEC) ECG Cable For CLEARSIGN™ Amplifier | 
| 08714729883159 | Stimulator Cable For CLEARSIGN™ Amplifier | 
| 08714729883142 | Stimulator Cable For CLEARSIGN™ Amplifier | 
| 08714729883135 | Stimulator Cable For CLEARSIGN™ Amplifier | 
| 08714729883111 | 40-Channel IC Junction Box For CLEARSIGN™ Amplifier | 
| 08714729883098 | 40-Channel IC Junction Box For CLEARSIGN™ Amplifier | 
| 08714729883074 | 40-Channel IC Junction Box For CLEARSIGN™ Amplifier | 
| 08714729883067 | 12 Lead ECG Cable for CLEARSIGN™ Amplifier | 
| 08714729883050 | 12 Lead ECG Cable for CLEARSIGN™ Amplifier | 
| 08714729883043 | 12 Lead ECG Cable for CLEARSIGN™ Amplifier | 
| 08714729882961 | RF Filter Module For CLEARSIGN™ Amplifier | 
| 08714729882763 | Radiotranslucent ECG Leadwires For CLEARSIGN™ Amplifier | 
| 08714729882749 | ECG Clip Leadwire Set for CLEARSIGN™ Amplifier | 
| 08714729882732 | ECG Banana Leadwire Set for CLEARSIGN™ Amplifier | 
| 08714729935902 | EP Recording System | 
| 08714729935872 | EP Recording System | 
| 08714729886013 | EP Recording System | 
| 08714729883999 | EP Recording System | 
| 08714729885979 | CLEARSIGN™ II Amplifier For LABSYSTEM™ PRO EP Recording System, 160 Channels | 
| 08714729885948 | CLEARSIGN™ II Amplifier For LABSYSTEM™ PRO EP Recording System, 160 Channels | 
| 08714729885924 | CLEARSIGN™ II Amplifier For LABSYSTEM™ PRO EP Recording System, 120 Channels | 
| 08714729885887 | CLEARSIGN™ II Amplifier For LABSYSTEM™ PRO EP Recording System, 80 Channels | 
| 08714729885849 | CLEARSIGN™ II Amplifier For LABSYSTEM™ PRO EP Recording System, 40 Channels | 
| 08714729884941 | CLEARSIGN™ II Amplifier For LABSYSTEM™ PRO EP Recording System, 120 Channels | 
| 08714729884897 | CLEARSIGN™ II Amplifier For LABSYSTEM™ PRO EP Recording System, 80 Channels | 
| 08714729884842 | CLEARSIGN™ II Amplifier For LABSYSTEM™ PRO EP Recording System, 40 Channels | 
| 08714729883920 | EP Recording System | 
| 08714729883357 | CLEARSIGN™ Amplifier For LABSYSTEM™ PRO EP Recording System, 40 Channels | 
| 08714729883302 | CLEARSIGN™ Amplifier For LABSYSTEM™ PRO EP Recording System, 80 Channels | 
| 08714729883258 | CLEARSIGN™ Amplifier For LABSYSTEM™ PRO EP Recording System, 120 Channels | 
| 08714729883005 | CLEARSIGN™ Amplifier For LABSYSTEM™ PRO EP Recording System, 160 Channels | 
| 08714729935896 | EP Recording System | 
| 08714729935889 | EP Recording System | 
| 08714729886006 | EP Recording System | 
| 08714729885993 | EP Recording System | 
| 08714729885962 | CLEARSIGN™ II Amplifier For LABSYSTEM™ PRO EP Recording System, 160 Channels | 
| 08714729885955 | CLEARSIGN™ II Amplifier For LABSYSTEM™ PRO EP Recording System, 160 Channels | 
| 08714729885917 | CLEARSIGN™ II Amplifier For LABSYSTEM™ PRO EP Recording System, 120 Channels | 
| 08714729885900 | CLEARSIGN™ II Amplifier For LABSYSTEM™ PRO EP Recording System, 120 Channels | 
| 08714729885870 | CLEARSIGN™ II Amplifier For LABSYSTEM™ PRO EP Recording System, 80 Channels | 
| 08714729885863 | CLEARSIGN™ II Amplifier For LABSYSTEM™ PRO EP Recording System, 80 Channels | 
| Mark Image Registration | Serial | Company Trademark Application Date | 
|---|---|
|  LABSYSTEM  73439317  not registered Dead/Abandoned | PSYCH SYSTEMS, INC. 1983-08-15 |