FDA.reportPublic FDA data

1ST284-100 LuMon™ Belt Size 104

Primary DI
07640121881718
Brand
1ST284-100 LuMon™ Belt Size 104
Company
SenTec AG
Model
1ST284-100
Published
2026-10-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
Single use
true

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
07640121881718PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640121881718076401218817187640121881718

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
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
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
076401218816261ST272-100 LuMon™ Belt Size 191ST272-1002026-10-26
076401218816331ST273-100 LuMon™ Belt Size 221ST273-1002026-10-26
076401218816401ST274-100 LuMon™ Belt Size 261ST274-1002026-10-26
076401218816571ST275-100 LuMon™ Belt Size 301ST275-1002026-10-26
076401218816641ST276-100 LuMon™ Belt Size 351ST276-1002026-10-26
076401218816711ST277-100 LuMon™ Belt Size 401ST277-1002026-10-26
076401218816881ST278-100 LuMon™ Belt Size 471ST278-1002026-10-26
076401218816951ST282-100 LuMon™ Belt Size 801ST282-1002026-10-26
076401218817011ST283-100 LuMon™ Belt Size 921ST283-1002026-10-26
076401218817251ST285-100 LuMon™ Belt Size 1161ST285-1002026-10-26
076401218817631ST120-100 LuMon™ Connector 2.01ST120-1002026-10-26
076401218817562ST200-100 LuMon™ Monitor2ST200-1002026-10-23
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
076401218816261ST272-100 LuMon™ Belt Size 19SenTec AGBZQ2026-10-26
076401218816261ST272-100 LuMon™ Belt Size 19SenTec AGQEB2026-10-26
076401218816331ST273-100 LuMon™ Belt Size 22SenTec AGBZQ2026-10-26
076401218816331ST273-100 LuMon™ Belt Size 22SenTec AGQEB2026-10-26
076401218816401ST274-100 LuMon™ Belt Size 26SenTec AGBZQ2026-10-26
076401218816401ST274-100 LuMon™ Belt Size 26SenTec AGQEB2026-10-26
076401218816571ST275-100 LuMon™ Belt Size 30SenTec AGBZQ2026-10-26
076401218816571ST275-100 LuMon™ Belt Size 30SenTec AGQEB2026-10-26
076401218816641ST276-100 LuMon™ Belt Size 35SenTec AGBZQ2026-10-26
076401218816641ST276-100 LuMon™ Belt Size 35SenTec AGQEB2026-10-26
076401218816711ST277-100 LuMon™ Belt Size 40SenTec AGBZQ2026-10-26
076401218816711ST277-100 LuMon™ Belt Size 40SenTec AGQEB2026-10-26
076401218816881ST278-100 LuMon™ Belt Size 47SenTec AGBZQ2026-10-26
076401218816881ST278-100 LuMon™ Belt Size 47SenTec AGQEB2026-10-26
076401218816951ST282-100 LuMon™ Belt Size 80SenTec AGQEB2026-10-26
076401218816951ST282-100 LuMon™ Belt Size 80SenTec AGBZQ2026-10-26
076401218817011ST283-100 LuMon™ Belt Size 92SenTec AGBZQ2026-10-26
076401218817011ST283-100 LuMon™ Belt Size 92SenTec AGQEB2026-10-26
076401218817251ST285-100 LuMon™ Belt Size 116SenTec AGBZQ2026-10-26
076401218817251ST285-100 LuMon™ Belt Size 116SenTec AGQEB2026-10-26
076401218817631ST120-100 LuMon™ Connector 2.0SenTec AGBZQ2026-10-26
076401218817631ST120-100 LuMon™ Connector 2.0SenTec AGQEB2026-10-26
076401218817562ST200-100 LuMon™ MonitorSenTec AGQEB2026-10-23
076401218817562ST200-100 LuMon™ MonitorSenTec AGBZQ2026-10-23
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