DEVICE: FF450plus (04049471093032)

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Device Identifier (DI) Information

FF450plus
FF450plus

Carl Zeiss Meditec AG
04049471093032
GS1
1
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 surrounding areas, to aid diagnosing or monitoring diseases of the eye that may be observed and photographed. If used in combination with dedicated optional equipment (electronic image sensors, digital archiving system) the system allows images to be displayed, stored, manipulated and archived digitally.
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Device Characteristics

Labeling does not contain MRI Safety Information
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GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Ophthalmic fundus camera An electrically-powered optical device intended to be used to create digital colour photographic images/video of the ocular fundus (interior eye surface opposite the lens) through the pupil, to aid in diagnosing and monitoring retinal pathology; it may also be used for images/video of the anterior chamber. The image/video is typically transferred to a computer for display on its screen and/or for storage in a database. This device is also known as a retinal camera.
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FDA Product Code

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Product Code Product Code Name
HKI Camera, Ophthalmic, Ac-Powered
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Sterilization

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Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
Storage Environment Humidity: between 10 and 95 Percent (%) Relative Humidity
Storage Environment Temperature: between -10 and 55 Degrees Celsius
Handling Environment Humidity: between 30 and 75 Percent (%) Relative Humidity
Handling Environment Temperature: between 10 and 35 Degrees Celsius
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Clinically Relevant Size

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Size Type Text
Device Size Text, specify: Dimension Fundus Camera: approx. 310mmx800mmx430mm
Device Size Text, specify: Dimension NAG: 132mmx440mmx360mm
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Device Status

In Commercial Distribution
January 15, 2016

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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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None
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Production Identifier(s) in UDI

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Customer Contact

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No Customer Contact currently defined
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