| Primary Device ID | 00859806007023 |
| NIH Device Record Key | c1ddbcd1-6c95-43f7-bf30-cf9730a1bc54 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Clarifi Imaging System |
| Version Model Number | Clarifi |
| Company DUNS | 603130928 |
| Company Name | MODULATED IMAGING INC. |
| 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 | 00859806007023 [Primary] |
| MUD | Oximeter, Tissue Saturation |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2019-04-19 |
| Device Publish Date | 2018-12-21 |
| 00859806007016 - Ox-Imager | 2020-07-01 The Ox-Imager CS™ is intended for use by healthcare professionals as a noninvasive tissue oxygenation measurement system that |
| 00859806007030 - Clarifi Cart | 2019-04-19 Cart |
| 00859806007023 - Clarifi Imaging System | 2019-04-19Tissue Saturation Oximeter |
| 00859806007023 - Clarifi Imaging System | 2019-04-19 Tissue Saturation Oximeter |