VesselNavigator 001013

GUDID 00884838064775

Software medical device, used with a Philips Interventional X-Ray System. Intended to assist in the treatment of endovascular diseases during an endovascular intervention procedure.

Philips Medical Systems Nederland B.V.

Angiographic x-ray system application software

• Primary Device ID: 00884838064775
• NIH Device Record Key: 9a83bfb2-6397-4d1d-972a-581724cd8d8d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VesselNavigator
• Version Model Number: VesselNavigator R1
• Catalog Number: 001013
• 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	00884838064775 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151598

FDA Product Code

• LLZ: System, Image Processing, Radiological

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: 2016-09-24

Devices Manufactured by Philips Medical Systems Nederland B.V.

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• 00884838119277 - Philips Sentinelle: 2024-12-25 dS 1.5T Interface Box
• 00884838119284 - Philips Sentinelle: 2024-12-25 dS 3.0T Interface Box
• 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