| Primary Device ID | 17640121880862 |
| NIH Device Record Key | 52e5368e-b856-406a-bc04-a28618b5c2fe |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Contact Gel |
| Version Model Number | GEL-SD |
| 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 | true |
| 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 |
| Weight | 0.3 Gram |
| Weight | 0.3 Gram |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 17640121880862 [Primary] |
| LPP | Monitor, Oxygen, Cutaneous, For Uses Other Than For Infant Not Under Gas Anesthesia |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-03-13 |
| Device Publish Date | 2019-03-05 |
| 07640121880070 | The Contact Gel is required for proper CO2 gas conduction from the patient’s skin to the SenTe |
| 17640121880862 | The Contact Gel is required for proper CO2 gas conduction from the patient's Skin to the SenTec |