| Primary Device ID | EMIP17000010 |
| NIH Device Record Key | abe516e2-d13f-49f5-b939-cecf7511623d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | MRI Patient Moitor Tesla DUO |
| Version Model Number | TeslaDUO |
| Catalog Number | 1700001 |
| Company DUNS | 324416379 |
| Company Name | MIPM Mammendorfer Institut für Physik und Medizin GmbH |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Conditional |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | true |
| 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 |
| Phone | +49814592090 |
| info@mipm.com |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | EMIP17000010 [Primary] |
| MWI | Monitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms) |
| 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 | 2016-08-25 |
| 04255629200508 - MRI Patient Monitor TeslaDUO | 2024-02-02 The MRI Patient Monitor TeslaDUO is intended for monitoring of vital signs during MRI examinations (MRI procedures) of patients. |
| 04255629200515 - TeslaDUO Remote Control | 2024-02-02 |
| 04255629200522 - Trolley TeslaDUO including MFI | 2024-02-02 |
| 04255629200553 - Wireless Pulse Oximetry Sensor for TeslaDUO | 2024-02-02 |
| 04255629200355 - SpO2 Finger Adapter M-Flex | 2023-12-22 |
| 04255629200379 - SpO2 Clip Adapter | 2023-12-22 |
| 04255629200874 - SpO2 Adapter, small, 10/box | 2023-12-22 |
| 04255629200881 - SpO2 Adapter, medium, 10/box | 2023-12-22 |