| Primary Device ID | 00884838124981 |
| NIH Device Record Key | d6df1637-9cde-4587-801f-c6f9270fc434 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Affiniti 50 Ultrasound System |
| Version Model Number | 795208 |
| 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 | 00884838124981 [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 | 2024-12-27 |
| Device Publish Date | 2024-12-19 |
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| 00884838124981 - Affiniti 50 Ultrasound System | 2024-12-27VM12.0 |
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| 00884838124233 - TOMTEC ARENA | 2024-07-11 |
| 00884838125674 - Affiniti CVx Diagnostic Ultrasound System Circular Edition | 2024-06-20 VM 11.0 update |