| Primary Device ID | 00850921007219 |
| NIH Device Record Key | be452eb1-d7cd-4254-bfcb-a2026945287d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | I-Streme Echo Ultrasound System |
| Version Model Number | 1 |
| Company DUNS | 079884004 |
| Company Name | INTERSON CORP |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | true |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850921007219 [Primary] |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-05-23 |
| Device Publish Date | 2018-03-02 |
| 00850921007257 - VPS Rhythm DLX Ultrasound Probe | 2020-11-09 VPS Rhythm DLX Ultrasound Probe |
| 00850921007271 - VPS Rhythm DLX Ultrasound Probe, Rebuilt | 2020-11-09 VPS Rhythm DLX Ultrasound Probe, Rebuilt |
| 00850921007202 - I-Streme Echo Ultrasound Software | 2020-04-30 |
| 00850921007004 - Interson | 2018-05-23 USB ultrasound probe, general purpose/abdominal |
| 00850921007011 - SeeMore | 2018-05-23 USB ultrasound probe, endocavity |
| 00850921007028 - SeeMore | 2018-05-23 USB ultrasound probe, general purpose/abdominal |
| 00850921007035 - SeeMore | 2018-05-23 USB ultrasound probe, general purpose/abdominal, with tablet computer |
| 00850921007042 - SeeMore | 2018-05-23 USB ultrasound probe, small parts/vascular access |