| Primary Device ID | 00840682154338 |
| NIH Device Record Key | 96aa540f-d83c-486f-ad58-17559cd3d639 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | D630 to D670 DR Upgrade |
| Version Model Number | H2401DS |
| Company DUNS | 654659689 |
| Company Name | Hangwei GE Medical Systems Co., Ltd. |
| 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 | true |
| Manufacturing Date | true |
| 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 | 00840682154338 [Primary] |
| KPS | System, tomography, computed, emission |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-04-06 |
| Device Publish Date | 2020-03-27 |
| 00195278685001 - OEC | 2025-01-17 MEDICAL DEVICE, UDI LABEL PLACEMENT, OEC One ASD |
| 00195278809810 - Revolution | 2025-01-03 Revolution RT Gantry designated Medical Device, GEHW |
| 00195278913807 - Definium | 2024-11-07 Definium Pace Select ET System UDI |
| 00195278832252 - NA | 2024-07-09 Galaxy 2.0 Wall Stand(Insert Left) |
| 00195278798107 - Revolution | 2024-03-07 Revolution Ascend Sliding designated medical device |
| 00195278788665 - Revolution Apex | 2024-01-03 Revolution Apex Select with Plus Edition - Designated System Medical Device |
| 00195278526892 - Definium | 2023-09-26 Definium Pace Select system designated medical device |
| 00195278713759 - NA | 2023-09-26 Galaxy 2.0 Wall Stand |