1ST276-100 LuMon™ Belt Size 35

Basic Information

• Brand Name: 1ST276-100 LuMon™ Belt Size 35
• Primary DI: EIT11ST2761000
• Version / Model: 1ST276-100
• Company Name: SenTec AG
• Labeler DUNS: 480797856
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-09-08
• Public Version: 1
• Public Version Date: 2025-09-16
• Public Version Status: New
• Public Device Record Key: 9f63c587-17a4-4b57-b068-985235968e2f

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
QEB	Ventilatory Electrical Impedance Tomograph	Anesthesiology	868.1505	2
BZQ	Monitor, Breathing Frequency	Anesthesiology	868.2375	2

GMDN Terms

Code	Name	Definition	Implantable	Status
57965	Thoracic electrical impedance system, tomographic	An 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	EIT11ST2761000	HIBCC

Premarket Submissions

Submission Number	Supplement Number
K243765	000