| Primary Device ID | 00858086006047 |
| NIH Device Record Key | 18b32558-0d1e-4684-afea-d2d3e6af1581 |
| Commercial Distribution Discontinuation | 2017-03-31 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | InfiMed Platinum One, RF, CCD Camera |
| Version Model Number | PlatinumOne RF |
| Company DUNS | 197117211 |
| Company Name | INFIMED, 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 | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00858086006047 [Primary] |
| JAA | System, x-ray, fluoroscopic, image-intensified |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2019-12-09 |
| Device Publish Date | 2016-09-16 |
| 00858086006009 - InfiMed i5, DSA, CCD Camera | 2019-12-09 |
| 00858086006016 - InfiMed i5, DR, Digital Receptor | 2019-12-09 |
| 00858086006023 - InfiMed Nexus, RF/DR, Non Varian Digital Receptor | 2019-12-09 |
| 00858086006030 - InfiMed Nexus, RF/DR, Digital Receptor | 2019-12-09 |
| 00858086006047 - InfiMed Platinum One, RF, CCD Camera | 2019-12-09 |
| 00858086006047 - InfiMed Platinum One, RF, CCD Camera | 2019-12-09 |
| 00858086006054 - InfiMed i5, RF, CCD Camera | 2019-12-09 |
| 00858086006061 - InfiMed Precision RXi, RF/DSA, CCD Camera | 2019-12-09 |
| 00858086006078 - InfiMed Precision MPi, RF, CCD Camera | 2019-12-09 |