AccessGUDID - DEVICE: KOWA VX-20 (04987646807278)

GUDID

Device Identifier (DI) Information

Brand Name: KOWA VX-20
Version or Model: K9L56BK
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: KOWA COMPANY,LTD.

Primary DI Number: 04987646807278
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 692281073 *Terms of Use

Device Description: The KOWA VX-20 is intended for taking pictures of retinal images with mydriatic or without mydriatic.

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):	Yes
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 [?]
K112330	000

Device Exempt from Premarket Submission: No 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 Temperature: between -15 and 55 Degrees Celsius
Handling Environment Humidity: between 30 and 90 Percent (%) Relative Humidity
Handling Environment Temperature: between 10 and 35 Degrees Celsius
Storage Environment Humidity: between 10 and 95 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
Height: 720 Millimeter
Depth: 540 Millimeter
Width: 390 Millimeter
Weight: 39 Kilogram

Device Record Status

Public Device Record Key: 3a2ff88e-4ba6-47ea-939d-190380f7b680
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 16, 2016