DEVICE: VISUCAM 224 (04049471093155)

Download: XML | JSON

Device Identifier (DI) Information

VISUCAM 224
VISUCAM 224

Carl Zeiss Meditec AG
04049471093155
GS1
1
The VISUCAM Digital Fundus Camera is suitable for photographing, displaying and storing data relating to the retina and surrounding parts of the eye beeing examined under mydriatic and non-mydriatic conditions. These photographs assist with the diagnosis and follow-up of eye diseases, which can be visually monitored and photographiacally documented.
CLOSE

Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
No
No
No
No
No

GMDN

[?]

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.
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
HKI Camera, Ophthalmic, Ac-Powered
CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

Storage and Handling

[?]
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 90 Percent (%) Relative Humidity
Handling Environment Temperature: between 10 and 35 Degrees Celsius
CLOSE

Clinically Relevant Size

[?]
Size Type Text
Device Size Text, specify: Dimension: approx. 400mmx500mmx730mm
Weight: 36 Kilogram
CLOSE

Device Status

In Commercial Distribution
January 15, 2016

CLOSE

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
No
Yes
No
Yes
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
CLOSE