| Primary Device ID | 00884838124233 |
| NIH Device Record Key | 6b471d92-a672-4d4b-af3a-cacfa42145ea |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TOMTEC ARENA |
| Version Model Number | TTA2.53 |
| Company DUNS | 063377717 |
| Company Name | Philips Ultrasound LLC |
| 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 | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00884838124233 [Primary] |
| QIH | Automated Radiological Image Processing Software |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-07-11 |
| Device Publish Date | 2024-07-03 |
| 00884838124912 - EPIQ Elite Diagnostic Ultrasound System | 2024-12-27 EPIQ Elite Diagnostic Ultrasound System VM 12.0. |
| 00884838124974 - Affiniti 30 Ultrasound System | 2024-12-27 Affiniti 30 Ultrasound System VM 12.0 |
| 00884838124981 - Affiniti 50 Ultrasound System | 2024-12-27 VM12.0 |
| 00884838124998 - Affiniti 70 Ultrasound System | 2024-12-27 VM12.0 |
| 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 |
| 00884838124233 - TOMTEC ARENA | 2024-07-11 |
| 00884838125674 - Affiniti CVx Diagnostic Ultrasound System Circular Edition | 2024-06-20 VM 11.0 update |