| Primary Device ID | 00884838125674 |
| NIH Device Record Key | 374faa72-2845-47de-b396-ba640213a877 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Affiniti CVx Diagnostic Ultrasound System Circular Edition |
| Version Model Number | 795407 |
| Company DUNS | 063377717 |
| Company Name | Philips Ultrasound LLC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Unsafe |
| 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 | 00884838125674 [Primary] |
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-06-20 |
| Device Publish Date | 2024-06-12 |
| 00884838109995 - EPIQ 7C Diagnostic Ultrasound System Circular Edition | 2024-08-19 VM 11.0 update |
| 00884838100213 - Transducer C5-1 | 2024-08-07 Introduction of C5-1 (Shanghai Version) to rest of the world. |
| 00884838124233 - TOMTEC ARENA | 2024-07-11 |
| 00884838125674 - Affiniti CVx Diagnostic Ultrasound System Circular Edition | 2024-06-20VM 11.0 update |
| 00884838125674 - Affiniti CVx Diagnostic Ultrasound System Circular Edition | 2024-06-20 VM 11.0 update |
| 00884838125643 - EPIQ CVx Diagnostic Ultrasound System Circular Edition | 2024-06-11 VM11.0 update |
| 00884838125650 - EPIQ 7 Diagnostic Ultrasound System Circular Edition | 2024-06-11 VM11.0 update |
| 00884838125667 - Affiniti 70 Diagnostic Ultrasound System Circular Edition | 2024-06-11 VM11.0 update |