AneurysmFlow 001015
GUDID 00884838064768
Software medical device, used with a Philips Interventional X-Ray System. Intended to assist with saccular cerebral aneurysm embolization, by visualizing and quantifying blood flow changes.
Philips Medical Systems Nederland B.V.
Angiographic x-ray system application software| Primary Device ID | 00884838064768 |
| NIH Device Record Key | 9ecaff46-3783-469e-a39b-f56a41b67e85 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | AneurysmFlow |
| Version Model Number | AneurysmFlow R1 |
| Catalog Number | 001015 |
| Company DUNS | 413819707 |
| Company Name | Philips Medical Systems Nederland B.V. |
| 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 | 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 Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00884838064768 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K160455
FDA Product Code
| OWB | Interventional Fluoroscopic X-Ray System |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 6 |
| Public Version Date | 2019-10-24 |
| Device Publish Date | 2017-03-03 |
Devices Manufactured by Philips Medical Systems Nederland B.V.
| 00884838118454 - Philips | 2024-07-26 MRI Needle Block 8G |
| 00884838118461 - Philips | 2024-07-26 Fiducial Marker Sleeve Assembly |
| 00884838118478 - Philips | 2024-07-26 FIDUCIAL MARKER GRID BLOCK ASSEMBLY |
| 00884838118485 - Philips | 2024-07-26 MRI Needle Block 12G |
| 00884838118492 - Philips | 2024-07-26 MRI Needle Block 14G |
| 00884838118508 - Philips | 2024-07-26 MRI Needle Block 16G |
| 00884838118515 - Philips | 2024-07-26 MRI Needle Block 18G |
| 00884838118522 - Philips | 2024-07-26 MRI Needle Sleeve 12G |
Trademark Results [AneurysmFlow]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ANEURYSMFLOW 79206337 not registered Dead/Abandoned |
Koninklijke Philips N.V. 2016-12-03 |
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