MAGNETOM Flow.Elite
GUDID 04068151047950
Siemens Healthcare GmbH
Full-body MRI system, superconducting magnet| Primary Device ID | 04068151047950 |
| NIH Device Record Key | b0e1a71c-167b-45aa-b2f6-2c86a9d8c1c4 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | MAGNETOM Flow.Elite |
| Version Model Number | 11878345 |
| Company DUNS | 313217003 |
| Company Name | Siemens Healthcare GmbH |
| 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 | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | +1(800)888-7436 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)888-7436 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)888-7436 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)888-7436 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)888-7436 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)888-7436 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)888-7436 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)888-7436 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)888-7436 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)888-7436 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)888-7436 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)888-7436 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)888-7436 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)888-7436 |
| CONTACT@SIEMENS-HEALTHINEERS.COM |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04068151047950 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K252838
FDA Product Code
| MOS | Coil, magnetic resonance, specialty |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2026-01-27 |
| Device Publish Date | 2026-01-19 |
On-Brand Devices [MAGNETOM Flow.Elite]
| 04068151047950 | 11878345 |
| 04068151036732 | 11851912 |
| 04068151034196 | 11851911 |
Trademark Results [MAGNETOM Flow.Elite]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 MAGNETOM FLOW.ELITE 79395338 not registered Live/Pending |
Siemens Healthineers AG 2024-04-04 |
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