FF450plus

GUDID 04049471093032

The FF 450plus is a monocular retina camera for routine use. It is designed to capture images of the eye, especially the retina area, as well as surro

Carl Zeiss Meditec AG

Ophthalmic fundus camera

• Primary Device ID: 04049471093032
• NIH Device Record Key: c32a9eea-b49b-4a4f-8798-9847ecccbb5e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FF450plus
• Version Model Number: FF450plus
• Company DUNS: 314594680
• Company Name: Carl Zeiss Meditec AG
• 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

• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	04049471093032 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K011877

FDA Product Code

• HKI: Camera, Ophthalmic, Ac-Powered

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: 2018-07-06
• Device Publish Date: 2016-01-15

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