DEVICE: VISUPAC 500 (04049471094077)

Device Identifier (DI) Information

VISUPAC 500
VISUPAC 500
In Commercial Distribution

Carl Zeiss Meditec AG
04049471094077
GS1

1
314594680 *Terms of Use
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
No
No
No
No
No
No
No
No

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 analyser software An application software program designed for the collection, processing, and display of data resulting from the measurement/evaluation of various properties of the posterior eye segment performed with an anterior eye segment analyser. It may be installed in the integrated analyser computer and/or an off-the-shelf computer (e.g., desktop, laptop).
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FDA Product Code

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Product Code Product Code Name
NFG Device, Communications, Images, Ophthalmic
NFF Device, Storage, Images, Ophthalmic
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization

No
No
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 Record Status

00e8f49f-398c-4d74-bd68-4da4468a7777
April 25, 2018
3
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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No
No
None
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Production Identifier(s) in UDI

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No
Yes
No
Yes
No CLOSE

Customer Contact

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No Customer Contact currently defined
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