i.Profiler plus 000000-1005-825

GUDID 04250668606625

N/A

Carl Zeiss Vision GmbH

Automated ophthalmic refractometer Automated ophthalmic refractometer Automated ophthalmic refractometer Automated ophthalmic refractometer Automated ophthalmic refractometer Automated ophthalmic refractometer Automated ophthalmic refractometer Automated ophthalmic refractometer Automated ophthalmic refractometer Automated ophthalmic refractometer Automated ophthalmic refractometer Automated ophthalmic refractometer Automated ophthalmic refractometer Automated ophthalmic refractometer Automated ophthalmic refractometer Automated ophthalmic refractometer Automated ophthalmic refractometer Automated ophthalmic refractometer Automated ophthalmic refractometer Automated ophthalmic refractometer Automated ophthalmic refractometer Automated ophthalmic refractometer Automated ophthalmic refractometer Automated ophthalmic refractometer Automated ophthalmic refractometer Automated ophthalmic refractometer Automated ophthalmic refractometer

• Primary Device ID: 04250668606625
• NIH Device Record Key: 5a78a953-d7a0-466a-b65d-4b418335a2dc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: i.Profiler plus
• Version Model Number: 000000-1005-825
• Catalog Number: 000000-1005-825
• Company DUNS: 333928146
• Company Name: Carl Zeiss Vision GmbH
• 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: +1(423)598-2680
• Email: jahmal.cannon@zeiss.com
• Phone: +1(423)598-2680
• Email: jahmal.cannon@zeiss.com
• Phone: +1(423)598-2680
• Email: jahmal.cannon@zeiss.com
• Phone: +1(423)598-2680
• Email: jahmal.cannon@zeiss.com
• Phone: +1(423)598-2680
• Email: jahmal.cannon@zeiss.com
• Phone: +1(423)598-2680
• Email: jahmal.cannon@zeiss.com
• Phone: +1(423)598-2680
• Email: jahmal.cannon@zeiss.com
• Phone: +1(423)598-2680
• Email: jahmal.cannon@zeiss.com
• Phone: +1(423)598-2680
• Email: jahmal.cannon@zeiss.com
• Phone: +1(423)598-2680
• Email: jahmal.cannon@zeiss.com
• Phone: +1(423)598-2680
• Email: jahmal.cannon@zeiss.com
• Phone: +1(423)598-2680
• Email: jahmal.cannon@zeiss.com
• Phone: +1(423)598-2680
• Email: jahmal.cannon@zeiss.com
• Phone: +1(423)598-2680
• Email: jahmal.cannon@zeiss.com
• Phone: +1(423)598-2680
• Email: jahmal.cannon@zeiss.com
• Phone: +1(423)598-2680
• Email: jahmal.cannon@zeiss.com
• Phone: +1(423)598-2680
• Email: jahmal.cannon@zeiss.com
• Phone: +1(423)598-2680
• Email: jahmal.cannon@zeiss.com
• Phone: +1(423)598-2680
• Email: jahmal.cannon@zeiss.com
• Phone: +1(423)598-2680
• Email: jahmal.cannon@zeiss.com
• Phone: +1(423)598-2680
• Email: jahmal.cannon@zeiss.com
• Phone: +1(423)598-2680
• Email: jahmal.cannon@zeiss.com
• Phone: +1(423)598-2680
• Email: jahmal.cannon@zeiss.com
• Phone: +1(423)598-2680
• Email: jahmal.cannon@zeiss.com
• Phone: +1(423)598-2680
• Email: jahmal.cannon@zeiss.com
• Phone: +1(423)598-2680
• Email: jahmal.cannon@zeiss.com
• Phone: +1(423)598-2680
• Email: jahmal.cannon@zeiss.com

Operating and Storage Conditions

• Storage Environment Humidity: Between 0 and 95 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 0 and 701 millibar
• Storage Environment Temperature: Between -10 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 0 and 95 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 0 and 701 millibar
• Storage Environment Temperature: Between -10 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 0 and 95 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 0 and 701 millibar
• Storage Environment Temperature: Between -10 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 0 and 95 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 0 and 701 millibar
• Storage Environment Temperature: Between -10 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 0 and 95 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 0 and 701 millibar
• Storage Environment Temperature: Between -10 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 0 and 95 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 0 and 701 millibar
• Storage Environment Temperature: Between -10 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 0 and 95 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 0 and 701 millibar
• Storage Environment Temperature: Between -10 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 0 and 95 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 0 and 701 millibar
• Storage Environment Temperature: Between -10 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 0 and 95 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 0 and 701 millibar
• Storage Environment Temperature: Between -10 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 0 and 95 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 0 and 701 millibar
• Storage Environment Temperature: Between -10 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 0 and 95 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 0 and 701 millibar
• Storage Environment Temperature: Between -10 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 0 and 95 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 0 and 701 millibar
• Storage Environment Temperature: Between -10 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 0 and 95 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 0 and 701 millibar
• Storage Environment Temperature: Between -10 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 0 and 95 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 0 and 701 millibar
• Storage Environment Temperature: Between -10 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 0 and 95 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 0 and 701 millibar
• Storage Environment Temperature: Between -10 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 0 and 95 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 0 and 701 millibar
• Storage Environment Temperature: Between -10 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	04250668606625 [Primary]

FDA Product Code

• HKO: Refractometer, ophthalmic

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: 2021-01-11
• Device Publish Date: 2021-01-01

On-Brand Devices [i.Profiler plus]

• 04250668606755: N/A
• 04250668606625: N/A