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- Country
- US
- Address
- 40 Albion Road, Lincoln, RI, 02865
- Website
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- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- 3012409105
- DUNS Number
- —
Catalogue (43)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| PSG Cable L | PSG Cable L | FDA UDI | Class II | Active |
| 103164 tCOM+ | 103164 | FDA UDI | Class II | Active |
| 1ST278-100 LuMon™ Belt Size 47 | 1ST278-100 | FDA UDI | Class II | Active |
| Neonatal Starter Set (without Service Gas) | SSET-N_nG | FDA UDI | Class II | Unknown |
| V-Sign™ Sensor 2 | VS-A/P/N | FDA UDI | Class II | Active |
| Standard Starter Set | SSET | FDA UDI | Class II | Unknown |
| PSG Cable A | PSG Cable A | FDA UDI | Class II | Active |
| 1ST285-100 LuMon™ Belt Size 116 | 1ST285-100 | FDA UDI | Class II | Active |
| 1ST273-100 LuMon™ Belt Size 22 | 1ST273-100 | FDA UDI | Class II | Active |
| 1ST272-100 LuMon™ Belt Size 19 | 1ST272-100 | FDA UDI | Class II | Active |
| 2ST200-100 LuMon™ Monitor | 2ST200-100 | FDA UDI | Class II | Active |
| PSG Cable E | PSG Cable E | FDA UDI | Class II | Active |
| Sentec Digital Monitor | SDM | FDA UDI | Class II | Active |
| 1ST283-100 LuMon™ Belt Size 92 | 1ST283-100 | FDA UDI | Class II | Active |
| PSG Cable K | PSG Cable K | FDA UDI | Class II | Active |
| PSG Cable F | PSG Cable F | FDA UDI | Class II | Active |
| Psg-X | PSG-X | FDA UDI | Class II | Active |
| PSG Cable P | PSG Cable P | FDA UDI | Class II | Active |
| 1ST284-100 LuMon™ Belt Size 104 | 1ST284-100 | FDA UDI | Class II | Active |
| OxiVenT™ Sensor | OV-A/P/N | FDA UDI | Class II | Active |
| 1ST120-100 LuMon™ Connector 2.0 | 1ST120-100 | FDA UDI | Class II | Active |
| SenTec Digital Monitor (with activated PO2 channel) | SDM-PO2 | FDA UDI | Class II | Unknown |
| Contact Gel 2ml | GEL-04 | FDA UDI | Class II | Unknown |
| PSG Cable M | PSG Cable M | FDA UDI | Class II | Active |
| 1ST274-100 LuMon™ Belt Size 26 | 1ST274-100 | FDA UDI | Class II | Active |
| Ear Clip easy | ECe-MI | FDA UDI | Class II | Unknown |
| PSG Cable C | PSG Cable C | FDA UDI | Class II | Active |
| 1ST276-100 LuMon™ Belt Size 35 | 1ST276-100 | FDA UDI | Class II | Active |
| V-STATS™ Installation CD | V-STATS_CD | FDA UDI | Class II | Active |
| Neonatal Starter Set | SSET-N | FDA UDI | Class II | Unknown |
| PSG Cable B | PSG Cable B | FDA UDI | Class II | Active |
| PSG Cable N | PSG Cable N | FDA UDI | Class II | Active |
| 1ST282-100 LuMon™ Belt Size 80 | 1ST282-100 | FDA UDI | Class II | Active |
| PSG Cable D | PSG Cable D | FDA UDI | Class II | Active |
| PSG Cable J | PSG Cable J | FDA UDI | Class II | Active |
| PSG Cable H | PSG Cable H | FDA UDI | Class II | Active |
| 103583 LuMon™ Contact Gel Kit | 103583 | FDA UDI | Class II | Active |
| Standard Starter Set (without Service Gas) | SSET_nG | FDA UDI | Class II | Active |
| 1ST277-100 LuMon™ Belt Size 40 | 1ST277-100 | FDA UDI | Class II | Active |
| PSG Cable G | PSG Cable G | FDA UDI | Class II | Active |
| 1ST275-100 LuMon™ Belt Size 30 | 1ST275-100 | FDA UDI | Class II | Active |
| Sentec Laser Guide Line, Model Sgl-05 | K862340 | FDA 510(k) | Class II | Active |
| Sentec Digital Monitor Model #sdm | K041548 | FDA 510(k) | Class II | Active |
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