Cellvizio® I.V.E.

GUDID 03760187912004

MAUNA KEA TECHNOLOGIES

Confocal endomicroscopy system Confocal endomicroscopy system Confocal endomicroscopy system

• Primary Device ID: 03760187912004
• NIH Device Record Key: ef89069f-47bc-4ac7-a9f0-9ebcca0a565e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cellvizio® I.V.E.
• Version Model Number: FP-10001
• Company DUNS: 394136118
• Company Name: MAUNA KEA TECHNOLOGIES
• 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

Customer Support Contacts

• Phone: +33170080967
• Email: support@maunakeatech.com
• Phone: +33170080967
• Email: support@maunakeatech.com
• Phone: +33170080967
• Email: support@maunakeatech.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	03760187912004 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K193416

FDA Product Code

• OWN: Confocal Optical Imaging

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: 2020-05-25
• Device Publish Date: 2020-05-15

On-Brand Devices [Cellvizio® I.V.E.]

• 03760187912004: FP-10001
• 03760187913001: FP-10001