LumiGuide LGHN35

GUDID 10884838111148

The LumiGuide 3D Hub enables the visualization of a connected endovascular catheter, when used in combination with a LumiGuide Wire and the LumiGuide Equipment.

Philips Medical Systems Nederland B.V.

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• Primary Device ID: 10884838111148
• NIH Device Record Key: 0fdb2566-caef-429f-8703-131698c12915
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LumiGuide
• Version Model Number: LumiGuide 3D Hub
• Catalog Number: LGHN35
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Dimensions

• Length: 90 Millimeter
• Lumen/Inner Diameter: 0.035 Inch
• Length: 90 Millimeter
• Lumen/Inner Diameter: 0.035 Inch
• Length: 90 Millimeter
• Lumen/Inner Diameter: 0.035 Inch
• Length: 90 Millimeter
• Lumen/Inner Diameter: 0.035 Inch
• Length: 90 Millimeter
• Lumen/Inner Diameter: 0.035 Inch
• Length: 90 Millimeter
• Lumen/Inner Diameter: 0.035 Inch
• Length: 90 Millimeter
• Lumen/Inner Diameter: 0.035 Inch
• Length: 90 Millimeter
• Lumen/Inner Diameter: 0.035 Inch
• Length: 90 Millimeter
• Lumen/Inner Diameter: 0.035 Inch
• Length: 90 Millimeter
• Lumen/Inner Diameter: 0.035 Inch
• Length: 90 Millimeter
• Lumen/Inner Diameter: 0.035 Inch
• Length: 90 Millimeter
• Lumen/Inner Diameter: 0.035 Inch

Device Identifiers

Device Issuing Agency	Device ID
GS1	00884838111141 [Primary]
GS1	10884838111148 [Package]; Contains: 00884838111141; Package: Case [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K233853

FDA Product Code

• DQK: Computer, Diagnostic, Programmable

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-04-01
• Device Publish Date: 2024-03-22

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