AccessGUDID - DEVICE: KOWA FM-600 (04987646804024)

GUDID

Device Identifier (DI) Information

Brand Name: KOWA FM-600
Version or Model: LSS50BK
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: KOWA COMPANY,LTD.

Primary DI Number: 04987646804024
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 692281073 *Terms of Use

Device Description: KOWA FM-600 is an instrument to measure the protein level contained in aqueous humor of the anterior chamber of human eye.

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?
37948	Aqueous flare/cell measuring system	An assembly of devices designed to measure aqueous flare (i.e., protein concentration) and the number of cells in the aqueous humour. It typically consists of light sources (e.g., lasers), a slit-lamp microscope, photo-multipliers, and dedicated software. The system measures the light scattered from the protein and cells in the aqueous humour using a photo-multiplier and analyse the results typically using a personal computer; it is mainly used to assess anterior chamber inflammation.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MYC	Ophthalmoscope,Laser,Scanning

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K091039	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 50 Degrees Celsius
Storage Environment Humidity: between 10 and 95 Percent (%) Relative Humidity
Handling Environment Temperature: between 10 and 40 Degrees Celsius
Handling Environment Humidity: between 30 and 60 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
Height: 458 Millimeter
Depth: 457 Millimeter
Width: 274 Millimeter
Weight: 18 Kilogram

Device Record Status

Public Device Record Key: cb1ee304-13ff-4c43-9105-03c9ade03685
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 16, 2016