NaviAid™ SPARKC 40-016

GUDID 07290018671504

The G-EYE® System comprises the G-EYE® Colonoscope and the NaviAid™ SPARKC (also "SPARKC") air control system which controls inflation and deflation of the G-EYE® balloon. The G-EYE® balloon is inflated using ambient air and controlled by the SPARKC via a foot pedal or a remote panel.

SMART MEDICAL SYSTEMS LTD

Catheter/overtube balloon inflator, reusable Catheter/overtube balloon inflator, reusable Catheter/overtube balloon inflator, reusable Catheter/overtube balloon inflator, reusable Catheter/overtube balloon inflator, reusable Catheter/overtube balloon inflator, reusable Catheter/overtube balloon inflator, reusable Catheter/overtube balloon inflator, reusable Catheter/overtube balloon inflator, reusable Catheter/overtube balloon inflator, reusable Catheter/overtube balloon inflator, reusable Catheter/overtube balloon inflator, reusable

• Primary Device ID: 07290018671504
• NIH Device Record Key: f8df187f-e162-4377-85ac-866d4e72edec
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NaviAid™ SPARKC
• Version Model Number: SPARKC
• Catalog Number: 40-016
• Company DUNS: 649905544
• Company Name: SMART MEDICAL SYSTEMS LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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: +97297444321
• Email: info@smartmedsys.com
• Phone: +97297444321
• Email: info@smartmedsys.com
• Phone: +97297444321
• Email: info@smartmedsys.com
• Phone: +97297444321
• Email: info@smartmedsys.com
• Phone: +97297444321
• Email: info@smartmedsys.com
• Phone: +97297444321
• Email: info@smartmedsys.com
• Phone: +97297444321
• Email: info@smartmedsys.com
• Phone: +97297444321
• Email: info@smartmedsys.com
• Phone: +97297444321
• Email: info@smartmedsys.com
• Phone: +97297444321
• Email: info@smartmedsys.com
• Phone: +97297444321
• Email: info@smartmedsys.com
• Phone: +97297444321
• Email: info@smartmedsys.com

Operating and Storage Conditions

• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 0.9 millibar and 1.1 millibar
• Storage Environment Atmospheric Pressure: Between 0.9 millibar and 1.1 millibar
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 0.9 millibar and 1.1 millibar
• Storage Environment Atmospheric Pressure: Between 0.9 millibar and 1.1 millibar
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 0.9 millibar and 1.1 millibar
• Storage Environment Atmospheric Pressure: Between 0.9 millibar and 1.1 millibar
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 0.9 millibar and 1.1 millibar
• Storage Environment Atmospheric Pressure: Between 0.9 millibar and 1.1 millibar
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 0.9 millibar and 1.1 millibar
• Storage Environment Atmospheric Pressure: Between 0.9 millibar and 1.1 millibar
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 0.9 millibar and 1.1 millibar
• Storage Environment Atmospheric Pressure: Between 0.9 millibar and 1.1 millibar
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 0.9 millibar and 1.1 millibar
• Storage Environment Atmospheric Pressure: Between 0.9 millibar and 1.1 millibar
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 0.9 millibar and 1.1 millibar
• Storage Environment Atmospheric Pressure: Between 0.9 millibar and 1.1 millibar
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 0.9 millibar and 1.1 millibar
• Storage Environment Atmospheric Pressure: Between 0.9 millibar and 1.1 millibar
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 0.9 millibar and 1.1 millibar
• Storage Environment Atmospheric Pressure: Between 0.9 millibar and 1.1 millibar
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 0.9 millibar and 1.1 millibar
• Storage Environment Atmospheric Pressure: Between 0.9 millibar and 1.1 millibar
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 0.9 millibar and 1.1 millibar
• Storage Environment Atmospheric Pressure: Between 0.9 millibar and 1.1 millibar
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290018671504 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202469

FDA Product Code

• FDF: Colonoscope And Accessories, Flexible/Rigid

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: 2020-12-10
• Device Publish Date: 2020-12-02

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