| Primary Device ID | 07640121880223 |
| NIH Device Record Key | b3486da9-4b79-4326-b12b-65f47065f0d4 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Multi-Site Attachment Ring for mature/intact skin |
| Version Model Number | MAR-MI |
| Company DUNS | 480797856 |
| Company Name | SenTec AG |
| Device Count | 1 |
| DM Exempt | true |
| 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 |
| Special Storage Condition, Specify | Between 0 and 0 *during transport: 0-50°C |
| Storage Environment Humidity | Between 25 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07640121880223 [Primary] |
| GS1 | 17640121880220 [Package] Package: Box [48 Units] In Commercial Distribution |
| 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 |
| 07640121880797 | Single use sensor application ring, recommended for adult, pediatric and neonatal patients with |
| 07640121880223 | MAR-MI is intended to attach SenTec TC Sensors to various measurement sites for patients with ma |