| Primary Device ID | 00884838126909 |
| NIH Device Record Key | 7237f6c8-6aad-49c2-937c-9295bb1df9c1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Affiniti CVx Diagnostic Ultrasound System |
| Version Model Number | 795190 |
| 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 | 00884838126909 [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 | 2025-07-01 |
| Device Publish Date | 2025-06-23 |
| 00884838126893 - EPIQ Diagnostic Ultrasound System Circular Edition | 2025-07-01 EPIQ CVx Diagnostic Ultrasound System Circular Edition |
| 00884838126909 - Affiniti CVx Diagnostic Ultrasound System | 2025-07-01Affiniti CVx Diagnostic Ultrasound System |
| 00884838126909 - Affiniti CVx Diagnostic Ultrasound System | 2025-07-01 Affiniti CVx Diagnostic Ultrasound System |
| 00884838126923 - EPIQ Diagnostic Ultrasound System | 2025-07-01 EPIQ CVx Diagnostic Ultrasound System |
| 00884838126930 - EPIQ Diagnostic Ultrasound System | 2025-07-01 EPIQ CVxi Diagnostic Ultrasound System |
| 00884838126947 - Affiniti CVx Diagnostic Ultrasound System Circular Edition | 2025-07-01 Affiniti CVx Diagnostic Ultrasound System Circular Edition |
| 00884838115354 - Ultrasound System 5100 POC | 2025-05-29 Flash Ultrasound System 5100 POC, release 1.0. |
| 00884838120174 - Ultrasound System 5100 POC Pro | 2025-05-29 Flash Ultrasound System 5100 POC, release 1.0. |
| 00884838125186 - Ultrasound Workspace | 2025-04-01 |