FDA UDI
In Commercial Distribution
🇺🇸 United States
103583 LuMon™ Contact Gel Kit
DI: 07640121881053
·
Model: 103583
·
SenTec AG
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- 103583 LuMon™ Contact Gel Kit
- Primary DI
- 07640121881053
- Version / Model
- 103583
- 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
- f143879e-a2ec-44ae-833f-448561b97798
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
- Labeling does not contain MRI Safety Information
- 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 | 07640121881053 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K243765 | 000 |