FDA UDI
In Commercial Distribution
🇺🇸 United States
2ST200-100 LuMon™ Monitor
DI: EIT12ST2001000
·
Model: 2ST200-100
·
SenTec AG
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- 2ST200-100 LuMon™ Monitor
- Primary DI
- EIT12ST2001000
- Version / Model
- 2ST200-100
- 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
- 0e27fc50-d7f8-44b8-818b-23b1c1d53542
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).
Device Characteristics
- Single Use
- No
- 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
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| BZQ | Monitor, Breathing Frequency | Anesthesiology | 868.2375 | 2 |
| QEB | Ventilatory Electrical Impedance Tomograph | Anesthesiology | 868.1505 | 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 | EIT12ST2001000 | HIBCC |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K243765 | 000 |