ZEISS

GUDID 03664188000589

LUNEAU TECHNOLOGY OPERATIONS

Multiple ocular dimension meter

• Primary Device ID: 03664188000589
• NIH Device Record Key: 1320e0dc-d0c8-4ebc-a10c-e17407d40ff6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ZEISS
• Version Model Number: VISUREF 1000
• Company DUNS: 260432380
• Company Name: LUNEAU TECHNOLOGY OPERATIONS
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	03664188000589 [Primary]

FDA Product Code

• HKI: Camera, Ophthalmic, Ac-Powered

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: 2025-03-19
• Device Publish Date: 2025-03-11

Devices Manufactured by LUNEAU TECHNOLOGY OPERATIONS

• 03664188000602 - VISIONIX: 2025-09-15
• 03664188000589 - ZEISS: 2025-03-19
• 03664188000589 - ZEISS: 2025-03-19
• 03664188000077 - VISIONIX: 2025-01-10 The VX65 is an automatic phoropter, to measure the subjective refraction, it is used as an ophthalmic device.
• 03664188000169 - VISIONIX: 2025-01-10 VX90 is an ophthalmic diagnostic device, autorefracto-keratometer
• 03664188000312 - Luneau: 2025-01-10 Measurement of corneal sensation, specifically tactile.
• 03664188000435 - ESSILOR: 2025-01-10 Automatic eye-fundus camera and software intended for photographing, displaying,and storing images of the retina without the use
• 03664188000558 - ESSILOR: 2025-01-10 WAM700+ is a multifunctional eye diagnostic device.
• 03664188000565 - ESSILOR: 2025-01-10 WAM800 is a multifunctional eye diagnostic device.