AccessGUDID - DEVICE: VISUCAM 224 (04049471093155)

GUDID

Device Identifier (DI) Information

Brand Name: VISUCAM 224
Version or Model: VISUCAM 224
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Carl Zeiss Meditec AG

Primary DI Number: 04049471093155
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 314594680 *Terms of Use

Device Description: 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.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
10551	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.	Active	false

FDA Product Code

[?]

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

FDA Premarket Submission

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

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

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

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Dimension: approx. 400mmx500mmx730mm
Weight: 36 Kilogram

Device Record Status

Public Device Record Key: 29cc8c3c-8219-4c89-80d6-2e6ffd44346a
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: January 15, 2016