ColoFlex™ N

GUDID 03760187912035

MAUNA KEA TECHNOLOGIES

Confocal endomicroscopy system probe

• Primary Device ID: 03760187912035
• NIH Device Record Key: 52af44fe-daca-4351-95ac-4557c6b2a032
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ColoFlex™ N
• Version Model Number: FP-10031
• 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
• Phone: +33170080967
• Email: support@maunakeatech.com
• Phone: +33170080967
• Email: support@maunakeatech.com
• 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	03760187912035 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K193416

FDA Product Code

• OWN: Confocal Optical Imaging

Sterilization

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

[03760187912035]

High-level Disinfectant

[03760187912035]

High-level Disinfectant

[03760187912035]

High-level Disinfectant

[03760187912035]

High-level Disinfectant

[03760187912035]

High-level Disinfectant

[03760187912035]

High-level Disinfectant

[03760187912035]

High-level Disinfectant

[03760187912035]

High-level Disinfectant

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

Devices Manufactured by MAUNA KEA TECHNOLOGIES

• 03760187913001 - Cellvizio® I.V.E.: 2024-03-07
• 03760187910772 - AQ-Flex™ 19-C: 2023-02-17
• 03760187912004 - Cellvizio® I.V.E.: 2020-05-25
• 03760187912011 - AlveoFlex™ N: 2020-05-25
• 03760187912028 - GastroFlex™ N: 2020-05-25
• 03760187912035 - ColoFlex™ N: 2020-05-25
• 03760187912035 - ColoFlex™ N: 2020-05-25
• 03760187912042 - CystoFlex™ R N: 2020-05-25
• 03760187912059 - AQ-Flex™ 19 N: 2020-05-25