DEVICE: VISUPAC 500 (04049471094077)

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Device Identifier (DI) Information

VISUPAC 500
VISUPAC 500

Carl Zeiss Meditec AG
04049471094077
GS1
1
The VISUPAC digital image capturing and archiving system is intended for capturing, displaying and storing images of the retina and surrounding area of the eye. These photographs support the diagnosis and progress monitoring of eye diseases which can be visually monitored and photographically documented.
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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
Posterior eye segment analysis system application software An individual software application program or group of programs that add specific computer assisted display, mark-up, processing and analysis capabilities to a posterior eye segment analysis system or system analyser. A basic set of programs are included with such systems and can be automatically or manually upgraded to correct programming errors or to add new system capabilities. It will typically have a documentation module, a viewer for consultation, and configured to process images (e.g., photographs and angiograms) of the posterior pole which aids in the identification of changes displayed in a series over time. It may also be used in an off-the-shelf desktop or laptop computer.
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FDA Product Code

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Product Code Product Code Name
NFF Device, Storage, Images, Ophthalmic
NFG Device, Communications, Images, Ophthalmic
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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 90 Percent (%) Relative Humidity
Storage Environment Temperature: between -40 and 70 Degrees Celsius
Handling Environment Humidity: between 10 and 70 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
Height: 400 Millimeter
Device Size Text, specify: Footprint: 574 mm x 76mm
Weight: 14 Kilogram
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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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