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.

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• 00884838119291 - Philips Sentinelle: 2024-12-25 dS 1.5T 8CH Medial
• 00884838119307 - Philips Sentinelle: 2024-12-25 dS 3.0T 8CH Medial
• 00884838119314 - Philips Sentinelle: 2024-12-25 dS 1.5T 4CH Lateral Left
• 00884838119321 - Philips Sentinelle: 2024-12-25 dS 3.0T 4CH Lateral Left
• 00884838119338 - Philips Sentinelle: 2024-12-25 dS 1.5T 4CH Lateral Right