FNS-2800 FE102/2

GUDID B366FE1022RX1

Laringoscope Non Rigid 2,8 mm.

Ecleris

Flexible video laryngoscope

• Primary Device ID: B366FE1022RX1
• NIH Device Record Key: fc85abf1-e9b9-4c34-8751-dcd863940dd6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FNS-2800
• Version Model Number: RX1
• Catalog Number: FE102/2
• Company DUNS: 043555079
• Company Name: Ecleris
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 786-483-7490
• Email: ytzielo@ecleris.com
• Phone: 786-483-7490
• Email: ytzielo@ecleris.com
• Phone: 786-483-7490
• Email: ytzielo@ecleris.com
• Phone: 786-483-7490
• Email: ytzielo@ecleris.com
• Phone: 786-483-7490
• Email: ytzielo@ecleris.com
• Phone: 786-483-7490
• Email: ytzielo@ecleris.com
• Phone: 786-483-7490
• Email: ytzielo@ecleris.com
• Phone: 786-483-7490
• Email: ytzielo@ecleris.com
• Phone: 786-483-7490
• Email: ytzielo@ecleris.com
• Phone: 786-483-7490
• Email: ytzielo@ecleris.com
• Phone: 786-483-7490
• Email: ytzielo@ecleris.com
• Phone: 786-483-7490
• Email: ytzielo@ecleris.com
• Phone: 786-483-7490
• Email: ytzielo@ecleris.com
• Phone: 786-483-7490
• Email: ytzielo@ecleris.com
• Phone: 786-483-7490
• Email: ytzielo@ecleris.com

Operating and Storage Conditions

• Handling Environment Temperature: Between 15 Degrees Celsius and 36 Degrees Celsius
• Handling Environment Humidity: Between 40 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 0 KiloPascal and 100 KiloPascal
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 100 KiloPascal
• Handling Environment Temperature: Between 15 Degrees Celsius and 36 Degrees Celsius
• Handling Environment Humidity: Between 40 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 0 KiloPascal and 100 KiloPascal
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 100 KiloPascal
• Handling Environment Temperature: Between 15 Degrees Celsius and 36 Degrees Celsius
• Handling Environment Humidity: Between 40 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 0 KiloPascal and 100 KiloPascal
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 100 KiloPascal
• Handling Environment Temperature: Between 15 Degrees Celsius and 36 Degrees Celsius
• Handling Environment Humidity: Between 40 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 0 KiloPascal and 100 KiloPascal
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 100 KiloPascal
• Handling Environment Temperature: Between 15 Degrees Celsius and 36 Degrees Celsius
• Handling Environment Humidity: Between 40 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 0 KiloPascal and 100 KiloPascal
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 100 KiloPascal
• Handling Environment Temperature: Between 15 Degrees Celsius and 36 Degrees Celsius
• Handling Environment Humidity: Between 40 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 0 KiloPascal and 100 KiloPascal
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 100 KiloPascal
• Handling Environment Temperature: Between 15 Degrees Celsius and 36 Degrees Celsius
• Handling Environment Humidity: Between 40 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 0 KiloPascal and 100 KiloPascal
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 100 KiloPascal
• Handling Environment Temperature: Between 15 Degrees Celsius and 36 Degrees Celsius
• Handling Environment Humidity: Between 40 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 0 KiloPascal and 100 KiloPascal
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 100 KiloPascal
• Handling Environment Temperature: Between 15 Degrees Celsius and 36 Degrees Celsius
• Handling Environment Humidity: Between 40 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 0 KiloPascal and 100 KiloPascal
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 100 KiloPascal
• Handling Environment Temperature: Between 15 Degrees Celsius and 36 Degrees Celsius
• Handling Environment Humidity: Between 40 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 0 KiloPascal and 100 KiloPascal
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 100 KiloPascal
• Handling Environment Temperature: Between 15 Degrees Celsius and 36 Degrees Celsius
• Handling Environment Humidity: Between 40 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 0 KiloPascal and 100 KiloPascal
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 100 KiloPascal
• Handling Environment Temperature: Between 15 Degrees Celsius and 36 Degrees Celsius
• Handling Environment Humidity: Between 40 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 0 KiloPascal and 100 KiloPascal
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 100 KiloPascal
• Handling Environment Temperature: Between 15 Degrees Celsius and 36 Degrees Celsius
• Handling Environment Humidity: Between 40 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 0 KiloPascal and 100 KiloPascal
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 100 KiloPascal
• Handling Environment Temperature: Between 15 Degrees Celsius and 36 Degrees Celsius
• Handling Environment Humidity: Between 40 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 0 KiloPascal and 100 KiloPascal
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 100 KiloPascal
• Handling Environment Temperature: Between 15 Degrees Celsius and 36 Degrees Celsius
• Handling Environment Humidity: Between 40 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 0 KiloPascal and 100 KiloPascal
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 100 KiloPascal

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B366FE1022RX1 [Primary]

FDA Product Code

• CAL: Laryngoscope, Non-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: 2024-08-19
• Device Publish Date: 2024-08-09

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• B366FE1022RX1 - FNS-2800: 2024-08-19Laringoscope Non Rigid 2,8 mm.
• B366FE1022RX1 - FNS-2800: 2024-08-19 Laringoscope Non Rigid 2,8 mm.
• B366U1OM200FLR01 - MICROSCOPE: 2024-08-02 MICROSCOPE
• B366U1OM200FR01 - MICROSCOPE: 2024-08-02 MICROSCOPE
• B366U1VI2021R01 - PROCAM HD 2D: 2024-07-26 PROCAM HD 2D
• B366VN1061 - VNG 3D: 2024-05-28 VIDEONISTAGMOGRAPHY SYSTEM