Visionix VSN5800NB

GUDID 04580606431522

CLINICAL UNIT SET

RIGHT MFG. CO., LTD.

Ophthalmic examination slit lamp

• Primary Device ID: 04580606431522
• NIH Device Record Key: 5b36113e-2075-485a-a2d4-efd7eab16953
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Visionix
• Version Model Number: MW50D
• Catalog Number: VSN5800NB
• Company DUNS: 713383495
• Company Name: RIGHT MFG. CO., LTD.
• 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: false
• OTC Over-The-Counter: false

Device Dimensions

• Width: 350 Millimeter
• Depth: 387 Millimeter
• Height: 678.5 Millimeter
• Weight: 14 Kilogram

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
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal

Device Identifiers

Device Issuing Agency	Device ID
GS1	04580606431522 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K110129

FDA Product Code

• HJO: Biomicroscope, Slit-Lamp, 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: 2023-01-13
• Device Publish Date: 2023-01-05

On-Brand Devices [Visionix ]

• 04580606431850: Bear Chart SET
• 04580606431843: Fireworks Chart SET
• 04580606431836: Tulip Chart SET
• 04580606431768: Bear Chart SET
• 04580606431751: Fireworks Chart SET
• 04580606431744: Tulip Chart SET
• 04580606431652: Tulip Chart SET
• 04580606431584: DIGITAL PHOTO UNIT SET
• 04580606431553: DIGITAL PHOTO UNIT SET
• 04580606431522: CLINICAL UNIT SET
• 04580606431492: CLINICAL UNIT SET