| Primary Device ID | 07640121880773 |
| NIH Device Record Key | b93d910a-9f6b-4edf-a6d7-0781dcb1606b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | V-STATS™ Installation CD |
| Version Model Number | V-STATS_CD |
| 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 | false |
| Serial Number | true |
| Manufacturing Date | false |
| Expiration Date | false |
| 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 | 07640121880773 [Primary] |
| DPZ | Oximeter, Ear |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-08-31 |
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| 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 |