LuMon(TM) System
Sentec AG
SENTEC, INC.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3012409105 | 3012409105 | SENTEC, INC. | 1 | Y | 2026-01-01 | 40 Albion Road Suite 100 Lincoln RI US 02865 |
| 3014683063 | 3014683063 | SENTECH USA INC | 1 | Y | 2026-01-01 | 19700 S.Vermont Ave. STE 200 Torrance CA US 90502 |
| 3014937935 | 3014937935 | SENTECH GMI Corp | 1 | N | 2026-01-01 | #1713~1714, 416, Hwagok-ro, Gangseo-gu Seoul KR 07548 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 195076 | 1506145158 | K151329 | SenTec Digital Monitor, OxiVenT Sensor, V-Sign Sensor, Staysite Adhesive Pad, V-STATS PC Software including V-CareNet | LKD | 2015-12-17 |
| 223090 | 1107251128 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| LKD | 1 | 2015-12-17 |
PMN#
Sentec Digital Monitoring System (SDMS) tCOM+
Sentec AG
SenTec Digital Monitor, OxiVenT Sensor, V-Sign Sensor, Staysite Adhesive Pad, V-STATS PC Software Including V-CareNet
SENTEC AG
SENTEC DIGITAL MONITOR, V-SIGN SENSOR AND V-SIGN SENSOR 2 WITH DIGITAL SENSOR ADAPER CABLE
SENTEC AG
SENTEC DIGITAL MONITORING SYSTEM
SENTEC AG
BREATH ALCOHOL TEST SYSTEM, MODEL AL-5000
SENTECH KOREA CORP.
BREATH ALCOHOL TEST SYSTEM, MODEL AL-6000
SENTECH KOREA CORP.
BREATH ALCOHOL TEST SYSTEM, MODEL AL 2500
SENTECH KOREA CORP.
SENTEC DIGITAL MONITOR MODEL #SDM
SENTEC INC.
PORTA GAS COMPRESSED GAS CYLINDER CART
SENTECH MEDICAL CORP.
SENTEC LASER GUIDE LINE, MODEL SGL-05
SENTEC CORP.
CHEM-PRO 1000 CLINICAL CHEMISTRY-ANALYSIS SYS
SENTECH MEDICAL CORP.
SENTECH'S ULAB 1000 CLINICAL CHEM.
SENTECH MEDICAL CORP.
GUDID#
Contact Gel 2ml - The Contact Gel is required for proper CO2 gas conduction from the patient's skin to the SenTec TC Sensors. Every time a SenTec TC Sensor is to be attached to the measurement site, one drop of Contact Gel must be applied to the center of the Sensor membrane.
2019-03-08
Multi-Site Attachment Ring for mature/intact skin - Single use sensor application ring, recommended for adult, pediatric and neonatal patients with mature/intact skin
2019-01-29
V-STATS™ Installation CD - PC based software required a) to configure special (safety-relevant) settings of the SenTec Digital Monitor (SDM), b) to manage ‘SDM Parameters Settings’ and c) to download trend data from the internal memory of the SDM to a PC. It includes features to analyze and view the downloaded trend data. The V-STATS™ software includes the V-CareNeT™ Package, which enables remote monitoring and alarm surveillance for multiple SDMs being connected to the same network as the PC with V-STATS™.
2016-08-31
PSG Cable P - The PSG Adapter Cable is intended to interface the SenTec Digital Monitor to Polygraphs (PG) or Polysomnographs (PSG)
2018-11-12
SenTec Digital Monitor (with activated PO2 channel) - Stand alone monitor with colour display for continuous non-invasive vital parameter monitoring, with integrated docking station for sensor storage and calibration.
2016-08-31
OxiVenT™ Sensor - Digital Sensor for non-invasive and continuous measurement of transcutaneous carbon dioxide and oxygen partial pressure as well as pulse oximetry. Suitable for adult, pediatric and neonatal patients.
2016-08-31
PSG Cable N - The PSG Adapter Cable is intended to interface the SenTec Digital Monitor to Polygraphs (PG) or Polysomnographs (PSG)
2018-11-12
PSG Cable M - The PSG Adapter Cable is intended to interface the SenTec Digital Monitor to Polygraphs (PG) or Polysomnographs (PSG).
2018-11-12
PSG Cable L - The PSG Adapter Cable is intended to interface the SenTec Digital Monitor to Polygraphs (PG) or Polysomnographs (PSG).
2018-11-12
PSG Cable K - The PSG Adapter Cable is intended to interface the SenTec Digital Monitor to Polygraphs (PG) or Polysomnographs (PSG)
2018-11-12
PSG Cable J - The PSG Adapter Cable is intended to interface the SenTec Digital Monitor to Polygraphs (PG) or Polysomnographs (PSG)
2018-11-12
PSG Cable H - The PSG Adapter Cable is intended to interface the SenTec Digital Monitor to Polygraphs (PG) or Polysomnographs (PSG)
2018-11-12
PSG Cable G - The PSG Adapter Cable is intended to interface the SenTec Digital Monitor to Polygraphs (PG) or Polysomnographs (PSG)
2018-11-12
PSG Cable F - The PSG Adapter Cable is intended to interface the SenTec Digital Monitor to Polygraphs (PG) or Polysomnographs (PSG)
2018-11-12
PSG Cable E - The PSG Adapter Cable is intended to interface the SenTec Digital Monitor to Polygraphs (PG) or Polysomnographs (PSG)
2018-11-12
PSG Cable D - The PSG Adapter Cable is intended to interface the SenTec Digital Monitor to Polygraphs (PG) or Polysomnographs (PSG)
2018-11-12
PSG Cable C - The PSG Adapter Cable is intended to interface the SenTec Digital Monitor to Polygraphs (PG) or Polysomnographs (PSG)
2018-11-12
PSG Cable B - The PSG Adapter Cable is intended to interface the SenTec Digital Monitor to Polygraphs (PG) or Polysomnographs (PSG)
2018-11-12
PSG Cable A - The PSG Adapter Cable is intended to interface the SenTec Digital Monitor to Polygraphs (PG) or Polysomnographs (PSG)
2018-11-12
Staysite Adhesive - The Staysite Adhesive (SA-MAR), is an optional, single-use adhesive which is indicated for use with Multi-Site Attachment Rings, models MAR-MI and MAR-SF if more secure attachment is required.
2016-08-31
V-Sign™ Sensor 2 - Digital Sensor for non-invasive and continuous measurement of transcutaneous carbon dioxide partial pressure and pulse oximetry. Suitable for adult, pediatric and neonatal patients.
2016-08-31
Membrane Changer Inserts - The Membrane Changer (MC-R) is a reloadable tool to change the membrane of SenTec TC Sensors. Prior reuse, the Membrane Changer (MC-R) must be reloaded with a new Membrane Changer Insert (MC-I). The MC-I is single-use
2016-08-31
Membrane Changer Set - The membrane and the electrolyte of SenTec TC Sensors must be changed periodically. For this purpose the old sensor membrane must be removed, the sensor surface must be cleaned, new electrolyte must be applied and a new sensor membrane must be put on. The patented Membrane Changer (MC-R) is a tool that allows the user to carry out the whole membrane change process by 4 simple press-and-turn steps. To enable an economic and cost saving membrane change, the Membrane Changer after use can be reloaded with a new Membrane Changer Insert (MC-I). The memrane changer set contains the MC-R and inserts (MC-I) to reload.Membrane Changer Set [1 membrane changer, 1 insert]
2016-08-31
Neonatal Starter Set (without Service Gas) - Neonatal Starter Set (without Service Gas) contains:Multi-Site Attachment Rings for mature/intact skin (MAR-MI)Multi-Site Attachment Rings for sensitive/fragile skin (MAR-SF)Membrane Changer tool (reloadable) (MC-R)Contact Gel (GEL-04)Service Gas (GAS-0812)
2016-08-31
Neonatal Starter Set - Neonatal Starter Set contains:Multi-Site Attachment Rings for mature/intact skin (MAR-MI)Multi-Site Attachment Rings for sensitive/fragile skin (MAR-SF)Membrane Changer tool (reloadable) (MC-R)Contact Gel (GEL-04)Service Gas (GAS-0812)
2016-08-31
PSG-X - The PSG Adapter Cable is intended to interface the SenTec Digital Monitor to Polygraphs (PG) or Polysomnographs (PSG)
2018-11-12
Standard Starter Set (without Service Gas) - Standard Starter Set (without Service Gas) contains:Ear Clips (EC-MI)Multi-Site Attachment Rings for mature/intact skin (MAR-MI)Multi-Site Attachment Rings for sensitive/fragile skin (MAR-SF)Membrane Changer tool (reloadable) (MC-R)Contact Gel (GEL-04)
2016-08-31
Multi-Site Attachment Ring for fragile/sensitive skin - MAR-SF is intended to attach SenTec TC Sensors to various measurement sites for patients with sensitive, fragile but intact skin.
2016-08-31
Multi-Site Attachment Ring for mature/intact skin - MAR-MI is intended to attach SenTec TC Sensors to various measurement sites for patients with mature, intact skin.
2016-08-31
Digital Sensor Adapter Cable, 750 cm - Adapter cable to connect SenTec TC Sensors to the SenTec Digital Monitor. The adapter cable is available in different lengths (XXX=150 cm, 250 cm, 750 cm).
2016-08-31
Digital Sensor Adapter Cable, 250 cm - Adapter cable to connect SenTec TC Sensors to the SenTec Digital Monitor. The adapter cable is available in different lengths (XXX=150 cm, 250 cm, 750 cm).
2016-08-31
Standard Starter Set - Standard Starter Set contains:Ear Clips (EC-MI)Multi-Site Attachment Rings for mature/intact skin (MAR-MI)Multi-Site Attachment Rings for sensitive/fragile skin (MAR-SF)Membrane Changer tool (reloadable) (MC-R)Contact Gel (GEL-04)Service Gas (GAS-0812)
2016-08-31
Membrane Changer (reloadable) / single unit - The membrane and the electrolyte of SenTec TC Sensors must be changed periodically. For this purpose the old sensor membrane must be removed, the sensor surface must be cleaned, new electrolyte must be applied and a new sensor membrane must be put on. The patented Membrane Changer (MC-R) is a tool that allows the user to carry out the whole membrane change process by 4 simple press-and-turn steps. To enable an economic and cost saving membrane change, the Membrane Changer after use can be reloaded with a new Membrane Changer Insert (MC-I).
2016-08-31
Contact Gel - The Contact Gel is required for proper CO2 gas conduction from the patient’s skin to the SenTec TC Sensors. Every time a SenTec TC Sensors is to be attached to the measurement site, one drop of Contact Gel must be applied to the center of the Sensor membrane.
2016-08-31
Service gas - The Service Gas is required for the calibration of the PCO2-part of SenTec TC Sensors. Depending on usage of the SDMS one Service Gas cylinder lasts for approx. 3 to 4 weeks.
2016-08-31
Ear Clip - The Ear Clip is required to attach SenTec TC Sensors to the patient’s earlobe. Suitable for patients with earlobes of sufficient size and mature, intact skin.
2016-08-31
Digital Sensor Adapter Cable, 150 cm - Adapter cable to connect SenTec TC Sensors to the SenTec Digital Monitor. The adapter cable is available in different lengths (XXX=150 cm, 250 cm, 750 cm).
2016-08-31
Sentec Digital Monitor - Stand alone monitor with colour display for continuous non-invasive vital parameter monitoring, with integrated docking station for sensor storage and calibration.
2016-08-31
Contact Gel - The Contact Gel is required for proper CO2 gas conduction from the patient's Skin to the SenTec TC Sensors. Every time a SenTec TC Sensors is to be attached to the measurement site, one drop of Contact Gel must be applied to the center of the Sensor Membrane. GEL-SD is delivered in single dose vials each containing 0.3 g of the solution and is intended for single use.
2019-03-05
Membrane Changer (single-use) / single unit - The membrane and the electrolyte of SenTec TC Sensors must be changed periodically. For this purpose the old sensor membrane must be removed, the sensor surface must be cleaned, new electrolyte must be applied and a new sensor membrane must be put on. The patented Membrane Changer (MC) is a tool that allows the user to carry out the whole membrane change process by 4 simple press-and-turn steps. The MC is single-use.
2021-02-28