LABSYSTEM™ PRO
- Primary DI
- 08714729882992
- Brand
- LABSYSTEM™ PRO
- Company
- BOSTON SCIENTIFIC CORPORATION
- Model
- M0042001232H0
- Catalog number
- M0042001232H0
- Device description
- CLEARSIGN™ Amplifier For LABSYSTEM™ PRO EP Recording System, 160 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
- OTC
- false
- Sterile
- false
- Single use
- false
Related Records
Product Codes
| Code | Name |
|---|---|
| DRQ | AMPLIFIER AND SIGNAL CONDITIONER, TRANSDUCER SIGNAL |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|---|---|---|
| DRQ | Amplifier And Signal Conditioner, Transducer Signal | Cardiovascular | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 08714729882992 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|---|---|
| 08714729882992 | 08714729882992 | 8714729882992 |
GMDN Terms
| Term | Definition |
|---|---|
| Multiple physiological signal amplifier | An 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 |
|---|
Regulatory Flags
- DUNS number
- 021717889
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- true
- Manufacturing date on label
- true
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
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|---|---|---|---|---|
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| 00191506004606 | WATCHMAN FLX™ Pro | M635WU60270 | M635WU60270 | 2023-09-12 |
| 00191506004613 | WATCHMAN FLX™ Pro | M635WU60310 | M635WU60310 | 2023-09-12 |
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| 00191506004637 | WATCHMAN FLX™ Pro | M635WU60400 | M635WU60400 | 2023-09-12 |
| 08714729195573 | RotaWire™ and wireClip™ Torquer | H802232390010 | H802232390010 | 2014-09-24 |
| 08714729195566 | RotaWire™ and wireClip™ Torquer | H802228240020 | H802228240020 | 2014-09-24 |
| 08714729837527 | Stingray™ | H749M3004A0 | 2016-09-24 | |
| 08714729877523 | EP XT™ | M0042007720 | M0042007720 | 2016-09-24 |
| 08714729877714 | Dynamic XT™ | M0042011120 | M0042011120 | 2016-09-24 |
| 08714729879947 | EP XT™ | M0046EPXT00390 | M0046EPXT00390 | 2016-09-24 |
| 08714729181088 | Percuflex™ Biliary | M00533760 | 2015-09-24 | |
| 08714729181095 | Percuflex™ Biliary | M00533770 | 2015-09-24 | |
| 08714729181101 | Percuflex™ Biliary | M00533780 | 2015-09-24 | |
| 08714729181118 | Percuflex™ Biliary | M00533790 | 2015-09-24 | |
| 08714729181125 | Percuflex™ Biliary | M00533800 | 2015-09-24 | |
| 08714729181132 | Percuflex™ Biliary | M00533810 | 2015-09-24 | |
| 08714729181149 | Percuflex™ Biliary | M00533820 | 2015-09-24 | |
| 08714729181156 | Percuflex™ Biliary | M00533830 | 2015-09-24 |
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| Primary DI | Brand | Company | Product code | Published |
|---|---|---|---|---|
| 00868924000267 | Monitor Input Cable, Mikro-Cath to EP-Tracer System | MILLAR INC. | DRQ | 2021-07-16 |
| 08714729882985 | LABSYSTEM™ PRO | BOSTON SCIENTIFIC CORPORATION | DRQ | 2019-12-13 |
| 08714729883234 | LABSYSTEM™ PRO | BOSTON SCIENTIFIC CORPORATION | DRQ | 2019-12-13 |
| 08714729883241 | LABSYSTEM™ PRO | BOSTON SCIENTIFIC CORPORATION | DRQ | 2019-12-13 |
| 08714729883289 | LABSYSTEM™ PRO | BOSTON SCIENTIFIC CORPORATION | DRQ | 2019-12-13 |
| 08714729883296 | LABSYSTEM™ PRO | BOSTON SCIENTIFIC CORPORATION | DRQ | 2019-12-13 |
| 08714729883333 | LABSYSTEM™ PRO | BOSTON SCIENTIFIC CORPORATION | DRQ | 2019-12-13 |
| 08714729883340 | LABSYSTEM™ PRO | BOSTON SCIENTIFIC CORPORATION | DRQ | 2019-12-13 |
| 08714729885825 | LABSYSTEM™ PRO | BOSTON SCIENTIFIC CORPORATION | DRQ | 2019-12-13 |
| 08714729885832 | LABSYSTEM™ PRO | BOSTON SCIENTIFIC CORPORATION | DRQ | 2019-12-13 |
| 08714729885863 | LABSYSTEM™ PRO | BOSTON SCIENTIFIC CORPORATION | DRQ | 2019-12-13 |
| 08714729885870 | LABSYSTEM™ PRO | BOSTON SCIENTIFIC CORPORATION | DRQ | 2019-12-13 |
| 08714729885900 | LABSYSTEM™ PRO | BOSTON SCIENTIFIC CORPORATION | DRQ | 2019-12-13 |
| 08714729885917 | LABSYSTEM™ PRO | BOSTON SCIENTIFIC CORPORATION | DRQ | 2019-12-13 |
| 08714729885955 | LABSYSTEM™ PRO | BOSTON SCIENTIFIC CORPORATION | DRQ | 2019-12-13 |
| 08714729885962 | LABSYSTEM™ PRO | BOSTON SCIENTIFIC CORPORATION | DRQ | 2019-12-13 |
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| 30841716101770 | RXi® Mini Navvus Interface Cable | ACIST MEDICAL SYSTEMS, INC. | DRQ | 2017-09-27 |
| 30841716101800 | RXi® Mini Navvus Interface Cable | ACIST MEDICAL SYSTEMS, INC. | DRQ | 2017-09-27 |
| 30841716101817 | RXi® Mini Navvus Interface Cable | ACIST MEDICAL SYSTEMS, INC. | DRQ | 2017-09-27 |
| 40841716101753 | ACIST RXi® Mini System Overpack | ACIST MEDICAL SYSTEMS, INC. | DRQ | 2017-09-25 |
| 00884838020917 | PHILIPS IntelliVue Invasive Pressure Module | Philips Medizin Systeme Böblingen GmbH | DRQ | 2016-10-06 |
| 00868924000212 | Pressure Control Unit PCU-2000 | MILLAR INC. | DRQ | 2016-09-30 |
| 08714729883005 | LABSYSTEM™ PRO | BOSTON SCIENTIFIC CORPORATION | DRQ | 2016-09-24 |
| 08714729883258 | LABSYSTEM™ PRO | BOSTON SCIENTIFIC CORPORATION | DRQ | 2016-09-24 |
| 08714729883302 | LABSYSTEM™ PRO | BOSTON SCIENTIFIC CORPORATION | DRQ | 2016-09-24 |
| 08714729883357 | LABSYSTEM™ PRO | BOSTON SCIENTIFIC CORPORATION | DRQ | 2016-09-24 |
| 08714729884842 | LABSYSTEM™ PRO | BOSTON SCIENTIFIC CORPORATION | DRQ | 2016-09-24 |
| 08714729884897 | LABSYSTEM™ PRO | BOSTON SCIENTIFIC CORPORATION | DRQ | 2016-09-24 |
| 08714729884941 | LABSYSTEM™ PRO | BOSTON SCIENTIFIC CORPORATION | DRQ | 2016-09-24 |