C-Quant

GUDID 04049584014795

C-Quant

OCULUS Optikgeräte Gesellschaft mit beschränkter Haftung

Binocular vision test unit

• Primary Device ID: 04049584014795
• NIH Device Record Key: b216fd4b-8624-4daa-b507-0982f2458e04
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: C-Quant
• Version Model Number: 80000
• Company DUNS: 317138956
• Company Name: OCULUS Optikgeräte Gesellschaft mit beschränkter Haftung
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal

Device Identifiers

Device Issuing Agency	Device ID
GS1	04049584014795 [Primary]

FDA Product Code

• HIT: Tester, Color Vision

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: 2022-12-15
• Device Publish Date: 2022-12-07

Devices Manufactured by OCULUS Optikgeräte Gesellschaft mit beschränkter Haftung

• 04049584037695 - Focusing Module BIOM 6, 175 mm: 2026-02-02
• 04049584037701 - Focusing Module BIOM 6, 200 mm: 2026-02-02
• 04049584037718 - Precision Mount for B&L: 2026-02-02
• 04049584037725 - Precision Mount for Leica: 2026-02-02
• 04049584037732 - Precision Mount for Alcon: 2026-02-02
• 04049584037749 - Precision Mount for Zeiss: 2026-02-02
• 04049584037756 - Precision Mount for Haag Streit: 2026-02-02
• 04049584035738 - BIOM 6 HD Optic Set for f=175 mm: 2026-01-22