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#
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
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
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
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
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
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
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
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
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
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
PSG-X - The PSG Adapter Cable is intended to interface the SenTec Digital Monitor to Polygraphs (PG) or Polysomnographs (PSG)
2018-11-12
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
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
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
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
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
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
PSG Cable A - The PSG Adapter Cable is intended to interface the SenTec Digital Monitor to Polygraphs (PG) or Polysomnographs (PSG)
2018-11-12
103421 Sensor Adapter Cable (Long) - The Sensor Adapter Cable is required to connect digital Sentec sensors (V-Sign™ Sensor 2, OxiVenT™ Sensor) to the Sentec tCOM+. The cable is available in different lengths: Regular, Long, Extra Long.
2024-07-05
Multi-Site Attachment Ring for fragile/sensitive skin - Single use sensor application ring, recommended for adult, pediatric and neonatal patients with sensitive/fragile skin
2019-01-29
Ear Clip easy - Single patient use sensor application ear clip, recommended for adult, pediatric and neonatal patients with mature/intact skin
2020-03-31
Patient Application Kit for mature intact skin - A combination of single-use products intended to attach the Sentec sensors to conventional measurement sites, recommended for adult, pediatric and neonatal patients with mature/intact skin
2021-09-26
Patient Application Kit for sensitive/fragile skin - A combination of single-use products intended to attach the Sentec Sensors to conventional measurement sites, recommended for adult, pediatric and neonatal patients with sensitive/fragile skin.
2021-09-26
Non-Adhesive Wrap - Sentec’s Non-Adhesive Wrap is intended to be wrapped around the thigh of neonatal patients with very sensitive/fragile skin for subsequent attachment of Sentec Sensors.Sentec’s Non-Adhesive Wrap is a non-adhesive application ring, single-patient use up to 24 hours, recommended for preterm / neonatal patients.
2023-07-21
103149 Calibration Gas - The Calibration Gas serves as calibration gas for the Sentec transcutaneous sensors that monitor tcPCO2 and/or tcPO2 (V-Sign™ Sensor 2 and OxiVenT™ Sensor).The Calibration Gas is for use only with the Docking Station integrated in the tCOM+.
2024-07-05
103164 tCOM+ - The Sentec patient monitor, model tCOM+, is a portable stand-alone patient monitor indicated for continuous, non-invasive patient monitoring of carbon dioxide partial pressure (PCO2), oxygen partial pressure (PO2), functional oxygen saturation (SpO2) and pulse rate (PR), using either:• a single, digital sensor (V-Sign™ Sensor 2) for PCO2, SpO2 and PR measurement, OR• a single, digital sensor (OxiVenT™ Sensor) for PCO2, PO2, SpO2 and PR measurementPO2 measurement with tCOM+ is only possible when used in combination with an OxiVenT™ Sensor.
2024-07-05
103420 Sensor Adapter Cable (Regular) - The Sensor Adapter Cable is required to connect digital Sentec sensors (V-Sign™ Sensor 2, OxiVenT™ Sensor) to the Sentec tCOM+. The cable is available in different lengths: Regular, Long, Extra Long.
2024-07-05
PSG Cable B - The PSG Adapter Cable is intended to interface the SenTec Digital Monitor to Polygraphs (PG) or Polysomnographs (PSG)
2018-11-12
103422 Sensor Adapter Cable (Extra Long) - The Sensor Adapter Cable is required to connect digital Sentec sensors (V-Sign™ Sensor 2, OxiVenT™ Sensor) to the Sentec tCOM+. The cable is available in different lengths: Regular, Long, Extra Long.
2024-07-05
Patient Application Kit with Ear Clip for mature/intact skin - A combination of single-use products intended to attach the Sentec sensors to the earlobe of the patient, recommended for patients with mature/intact skin.
2021-09-26
SDM Water Protection Cover - This cover will protect the SenTec Digital Monitor (SDM) from dripping water when the device is tilted up to 15° (IPX2).
2021-08-25
Isolation Transformer 100-120V - Isolates the SDM from mains for use in home use environments.
2021-05-05
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
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
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
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
PSG Cable C - The PSG Adapter Cable is intended to interface the SenTec Digital Monitor to Polygraphs (PG) or Polysomnographs (PSG)
2018-11-12
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