Digital Refractor HDR-7000P HDR-7000P

GUDID 08800019600817

Digital Refractor system is a computerized auto refractor used for subjective refraction by regarding the patient’s accommodation power and facilities.

Huvitz Co., Ltd.

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• Primary Device ID: 08800019600817
• NIH Device Record Key: 978e62c4-90a7-43d8-a0b5-ad89461a3b3c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Digital Refractor HDR-7000P
• Version Model Number: HDR-7000P
• Catalog Number: HDR-7000P
• Company DUNS: 688154202
• Company Name: Huvitz Co., Ltd.
• 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: +82314289100
• Email: svc@huvitz.com
• Phone: +82314289100
• Email: svc@huvitz.com
• Phone: +82314289100
• Email: svc@huvitz.com
• Phone: +82314289100
• Email: svc@huvitz.com
• Phone: +82314289100
• Email: svc@huvitz.com
• Phone: +82314289100
• Email: svc@huvitz.com
• Phone: +82314289100
• Email: svc@huvitz.com
• Phone: +82314289100
• Email: svc@huvitz.com
• Phone: +82314289100
• Email: svc@huvitz.com
• Phone: +82314289100
• Email: svc@huvitz.com
• Phone: +82314289100
• Email: svc@huvitz.com
• Phone: +82314289100
• Email: svc@huvitz.com
• Phone: +82314289100
• Email: svc@huvitz.com
• Phone: +82314289100
• Email: svc@huvitz.com
• Phone: +82314289100
• Email: svc@huvitz.com
• Phone: +82314289100
• Email: svc@huvitz.com

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800019600817 [Primary]

FDA Product Code

• HKN: Refractor, Manual, Non-Powered, Including Phoropter

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: 2023-06-20
• Device Publish Date: 2023-06-12

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