Procam HD CMOS II CONSOLE U1HC120G21

GUDID B366U1HC120G21

Procam HD CMOS II CONSOLE

Ecleris

Surgical video camera

• Primary Device ID: B366U1HC120G21
• NIH Device Record Key: 42edce20-f74f-40bb-9753-341036fd0469
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Procam HD CMOS II CONSOLE
• Version Model Number: R03
• Catalog Number: U1HC120G21
• 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

Operating and Storage Conditions

• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 35 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 35 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 35 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 35 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 35 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 35 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 35 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 35 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B366U1HC120G21 [Primary]

FDA Product Code

• FWD: Camera, Television, Microsurgical, Without Audio

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: 2022-07-05
• Device Publish Date: 2022-06-27

Devices Manufactured by Ecleris

• B366U1VI3603RX1 - Procam HD II: 2024-10-03 Procam HD II
• B366U1RH1011 - R-FLOWMETER: 2024-08-26 COMPUTERIZED FLOWMETER
• B366FE1021RX1 - FNS-3200: 2024-08-19 Laringoscope Non Rigid 3,2 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