| 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 |
| 00884838123625 - Ultrasound System 5500CV | 2025-07-28 As part of SW 2.0 |
| 00884838123632 - Ultrasound System 5500P | 2025-07-28 Part of SW 2.0 |
| 00884838123649 - Ultrasound System 5500W | 2025-07-28 Part of SW 2.0 |
| 00884838123656 - Ultrasound System 5300G | 2025-07-28 Part of SW 2.0 |
| 00884838123663 - Ultrasound System 5300W | 2025-07-28 As part of SW 2.0 |
| 00884838123670 - Ultrasound System 5300P | 2025-07-28 As part of SW 2.0 |
| 00884838123687 - Ultrasound System 5500G | 2025-07-28 As part of SW 2.0 |
| 00884838125964 - Lumify USB-C to USB-C Transducer cable | 2025-07-22 Lumify USB-C to USB-C Transducer cable |