LumiGuide 722480

GUDID 00884838112087

Visualization device with FORS technology intended to aid the positioning and navigation of a connected AltaTrack Guidewire and optionally a catheter during endovascular procedures of the peripheral, aortic and aortic side branch vasculature, by creating a 3D image in real time of the connected AltaTrack Guidewire, and of an endovascular catheter, when combined with an AltaTrack 3D Hub.

Philips Medical Systems Nederland B.V.

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• Primary Device ID: 00884838112087
• NIH Device Record Key: 147b1f2d-489d-4199-b924-f5e02f6b55de
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LumiGuide
• Version Model Number: LumiGuide Equipment
• Catalog Number: 722480
• 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: 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	00884838112087 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K223918

FDA Product Code

• DQK: Computer, Diagnostic, Programmable

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: 2023-09-26
• Device Publish Date: 2023-09-18

On-Brand Devices [LumiGuide]

• 00884838112087: Visualization device with FORS technology intended to aid the positioning and navigation of a co
• 10884838111148: The LumiGuide 3D Hub enables the visualization of a connected endovascular catheter, when used i
• 00884838111127: Angiographic guidewire with FORS technology, intended to direct a catheter during navigation in
• 00884838111110: Angiographic guidewire with FORS technology, intended to direct a catheter during navigation in