| Primary Device ID | 00884838067523 |
| NIH Device Record Key | 609ed408-503c-4499-bbc3-46a63d3b5cf9 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Transducer S8-3t |
| Version Model Number | 989605420183 |
| Company DUNS | 063377717 |
| Company Name | Philips Ultrasound, 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 | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00884838067523 [Primary] |
| IYN | System, imaging, pulsed doppler, ultrasonic |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2018-11-12 |
| Device Publish Date | 2016-04-30 |
| 00884838122277 - QLAB Advanced Quantification Software | 2024-06-06 VM11.0 update |
| 00884838123960 - EPIQ CVx Diagnostic Ultrasound System | 2024-06-06 VM11.0 Update |
| 00884838123977 - EPIQ CVxi Diagnostic Ultrasound System | 2024-06-06 VM 11.0 Update |
| 00884838123984 - Affiniti CVx Diagnostic Ultrasound System | 2024-06-06 VM11.0 update |
| 00884838114265 - Affinti 30 Diagnostic Ultrasound System Circular Edition | 2024-06-04 VM10.0 Update |
| 00884838114241 - Affinti 50 Diaagnostic Ultrasound System Circular Edition | 2024-05-13 Software Version 10.0.2 |
| 00884838114258 - Affinti 70 Diaagnostic Ultrasound System Circular Edition | 2024-05-13 Software Version 10.0.2 |
| 00884838114203 - EPIQ 7 Diagnostic Ultrasound System Circular Edition | 2024-04-18 10.0.X Circular Edition |