AccessGUDID - DEVICE: KOWA nonmyd 8 (04987646807575)

GUDID

Device Identifier (DI) Information

Brand Name: KOWA nonmyd 8
Version or Model: K9L61K
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: KOWA COMPANY,LTD.

Primary DI Number: 04987646807575
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 692281073 *Terms of Use

Device Description: The KOWA nonmyd 8 is intended for use with retinal image capturing 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

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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
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.

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.

FDA Product Code

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Product Code	Product Code Name
PJZ	Camera, Ophthalmic, General-Use

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

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Storage and Handling
Storage Environment Temperature: between -10 and 55 Degrees Celsius
Storage Environment Humidity: between 10 and 95 Percent (%) Relative Humidity
Handling Environment Temperature: between 10 and 35 Degrees Celsius
Handling Environment Humidity: between 30 and 90 Percent (%) Relative Humidity

Clinically Relevant Size

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Size Type Text
Width: 310 Millimeter
Depth: 504 Millimeter
Height: 548 Millimeter
Weight: 21 Kilogram

Device Record Status

Public Device Record Key: 7518b824-978a-4c90-bac9-b7d927eec52a
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 16, 2016