| Primary Device ID | 07640121881053 |
| NIH Device Record Key | f143879e-a2ec-44ae-833f-448561b97798 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | 103583 LuMon™ Contact Gel Kit |
| Version Model Number | 103583 |
| Company DUNS | 480797856 |
| Company Name | SenTec AG |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07640121881053 [Primary] |
| QEB | Ventilatory Electrical Impedance Tomograph |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-09-16 |
| Device Publish Date | 2025-09-08 |
| 07640121881053 - 103583 LuMon™ Contact Gel Kit | 2025-09-16 |
| 07640121881053 - 103583 LuMon™ Contact Gel Kit | 2025-09-16 |
| EIT11ST1201000 - 1ST120-100 LuMon™ Connector 2.0 | 2025-09-16 The LuMon Connector 2.0 is a reusable adapter intended to link a LuMon™ Belt to the LuMon™ Monitor. |
| EIT11ST2721000 - 1ST272-100 LuMon™ Belt Size 19 | 2025-09-16 |
| EIT11ST2731000 - 1ST273-100 LuMon™ Belt Size 22 | 2025-09-16 |
| EIT11ST2741000 - 1ST274-100 LuMon™ Belt Size 26 | 2025-09-16 |
| EIT11ST2751000 - 1ST275-100 LuMon™ Belt Size 30 | 2025-09-16 |
| EIT11ST2761000 - 1ST276-100 LuMon™ Belt Size 35 | 2025-09-16 |
| EIT11ST2771000 - 1ST277-100 LuMon™ Belt Size 40 | 2025-09-16 |