FDA.reportPublic FDA data

2ST200-100 LuMon™ Monitor

Primary DI
07640121881756
Brand
2ST200-100 LuMon™ Monitor
Company
SenTec AG
Model
2ST200-100
Device description
The LuMon™ Monitor is a noninvasive, non-radiological monitoring device that provides an assessment of regional impedance variation within a cross-section of a patient's thorax using an electrical impedance measuring device (LuMon™ Connector 2.0), an electrode belt (LuMon™ Belt) and a contact medium (LuMon™ Contact Gel).
Published
2026-10-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
BZQMonitor, Breathing Frequency
QEBVentilatory Electrical Impedance Tomograph

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BZQMonitor, Breathing FrequencyAnesthesiology2
QEBVentilatory Electrical Impedance TomographAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K243765000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K243765000LuMon(TM) SystemSentec AG2025-08-07QEB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07640121881756PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640121881756076401218817567640121881756

GMDN Terms#

Term, Definition table
TermDefinition
Thoracic electrical impedance system, tomographicAn assembly of devices designed to perform continuous bioimpedance measurements throughout a cross-section of the thorax, to provide real-time feedback of lung function during controlled, assisted or spontaneous ventilation. It typically consists of a mobile trolley, an electrically-powered unit with a monitor and controls, connecting cables, and an electrode chest belt (typically with 16-32 electrodes). The technique [electrical impedance tomography (EIT)] uses single-frequency, low-amplitude alternating current applied by a pair of electrodes whereby the generated electrical potentials at the body surface are continuously measured by other electrodes.

Regulatory Flags#

DUNS number
480797856
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07640121880803Multi-Site Attachment Ring for fragile/sensitive skinMARe-SF2019-01-29
07640121880810Ear Clip easyECe-MI2020-03-31
07640121880964Patient Application Kit for mature intact skinPAK-MI2021-09-26
07640121880971Patient Application Kit for sensitive/fragile skinPAK-SF2021-09-26
07640121881039Non-Adhesive Wrap1035202023-07-21
07640121880988103149 Calibration Gas1031492024-07-05
07640121880995103164 tCOM+1031642024-07-05
07640121881008103420 Sensor Adapter Cable (Regular)1034202024-07-05
07640121881015103421 Sensor Adapter Cable (Long)1034212024-07-05
07640121881022103422 Sensor Adapter Cable (Extra Long)1034222024-07-05
07640121880957Patient Application Kit with Ear Clip for mature/intact skinPAK-EC2021-09-26
07640121880889SDM Water Protection CoverSDM_WPC2021-08-25
07640121880902Isolation Transformer 100-120VRFT100VA-V12021-05-05
07640121880933Membrane Changer (single-use) / single unitMC2021-02-28
17640121880862Contact GelGEL-SD2019-03-05
07640121880018Sentec Digital MonitorSDM2016-08-31
07640121880032Digital Sensor Adapter Cable, 150 cmAC-1502016-08-31
07640121880049Ear ClipEC-MI2016-08-31
07640121880056Service gasGAS-08122016-08-31
07640121880070Contact GelGEL-042016-08-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07898966433023ENLIGHT BELT - P0 - LEFTTimpel S/AQEB2026-10-08
07898966433030ENLIGHT BELT - P0 - RIGHTTimpel S/AQEB2026-10-08
07898966433047ENLIGHT BELT - P1 - LEFTTimpel S/AQEB2026-10-08
07898966433054ENLIGHT BELT - P1 - RIGHTTimpel S/AQEB2026-10-08
07898966433061ENLIGHT BELT - P1 - LEFTTimpel S/AQEB2026-10-08
07898966433078ENLIGHT BELT - P2 - RIGHTTimpel S/AQEB2026-10-08
00195278949752TruSignal SpO2 MM 3.0MGE Healthcare Finland OyBZQ2026-10-04
00195278949769TruSignal SpO2 MM 1.8MGE Healthcare Finland OyBZQ2026-10-04
00198953002186Carescape Dock F0GE Healthcare Finland OyBZQ2026-10-04
00198953009567Carescape ONEGE Healthcare Finland OyBZQ2026-10-04
89061709200204DOZEETURTLE SHELL TECHNOLOGIES PRIVATE LIMITEDBZQ2026-08-19
07908715700464ADHESIVE BELT STimpel S/AQEB2026-07-24
07908715700518ADHESIVE BELT XSTimpel S/AQEB2026-07-24
07908715700525ADHESIVE BELT MTimpel S/AQEB2026-07-24
07908715700532ADHESIVE BELT LTimpel S/AQEB2026-07-24
07908715700549ADHESIVE BELT XLTimpel S/AQEB2026-07-24
07908715700976ADHESIVE BELT P0Timpel S/AQEB2026-07-24
07908715700983ADHESIVE BELT P1Timpel S/AQEB2026-07-24
07908715700990ADHESIVE BELT P2Timpel S/AQEB2026-07-24
07908715701003ADHESIVE BELT P3Timpel S/AQEB2026-07-24
07908715701010ADHESIVE BELT P4Timpel S/AQEB2026-07-24
07908715701027ADHESIVE BELT XXSTimpel S/AQEB2026-07-24
07908715701492SENSOR BELT XSTimpel S/AQEB2026-07-24
07908715701522SENSOR BELT STimpel S/AQEB2026-07-24
07908715701553SENSOR BELT MTimpel S/AQEB2026-07-24
07908715701584SENSOR BELT LTimpel S/AQEB2026-07-24
07908715701614SENSOR BELT XLTimpel S/AQEB2026-07-24
07908715701706PULMOMAPTimpel S/AQEB2026-07-18
00850086928008SENSINEL™ CPM BASE STATIONAnalog Devices, Inc.BZQ2026-06-03
00850086928015SENSINEL™ CPM WEARABLEAnalog Devices, Inc.BZQ2026-06-03