Ventri
GUDID 00840682121644
G E MEDICAL SYSTEMS ISRAEL LTD.
Stationary gamma camera system| Primary Device ID | 00840682121644 |
| NIH Device Record Key | c8e05298-1677-414b-8153-2af05097405d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Ventri |
| Version Model Number | H3000YT |
| Company DUNS | 532102365 |
| Company Name | G E MEDICAL SYSTEMS ISRAEL 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 | false |
| 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 Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00840682121644 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K051855
FDA Product Code
| KPS | System, tomography, computed, emission |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-08-22 |
Devices Manufactured by G E MEDICAL SYSTEMS ISRAEL LTD.
| 00195278870490 - StarGuide MDD to MDR Upgrade | 2024-05-24 StarGuide SW and Labels Upgrade |
| 00195278755544 - StarGuide | 2024-04-26 StarGuide NM GANTRY MDR FINAL |
| 00195278794772 - D630 to D670 DR Upgrade | 2024-03-26 D630 to D670 DR NM GANTRY UPGRADE KIT |
| 00195278788252 - NM | 2023-11-23 830 NM GANTRY FINAL WITH NEW ROTOR - MDR CE |
| 00195278788269 - NMCT | 2023-11-22 870 DR NM GANTRY FINAL WITH NEW ROTOR - MDR CE |
| 00195278488619 - MyoSPECT | 2023-09-22 MyoSPECT MDR GANTRY |
| 00195278488626 - MyoSPECT ES | 2023-09-22 MyoSPECT ES MDR GANTRY |
| 00195278722546 - MyoSEPCT ES to MyoSPECT Upgrade | 2023-09-22 MyoSPECT ES to MyoSPECT Upgrade kit |
Trademark Results [Ventri]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 VENTRI 78610635 3160750 Dead/Cancelled |
General Electric Company 2005-04-18 |
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