VISUPAC 500

GUDID 04049471094077

The VISUPAC digital image capturing and archiving system is intended for capturing, displaying and storing images of the retina and surrounding area o

Carl Zeiss Meditec AG

Posterior eye segment analyser software

• Primary Device ID: 04049471094077
• NIH Device Record Key: 00e8f49f-398c-4d74-bd68-4da4468a7777
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VISUPAC 500
• Version Model Number: VISUPAC 500
• Company DUNS: 314594680
• Company Name: Carl Zeiss Meditec AG
• 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

Device Dimensions

• Height: 400 Millimeter
• Device Size Text, specify: 0
• Weight: 14 Kilogram

Operating and Storage Conditions

• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	04049471094077 [Primary]

FDA Product Code

• NFG: Device, Communications, Images, Ophthalmic

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-04-25
• Device Publish Date: 2016-01-15

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