DEVICE: KOWA FM-600 (04987646804024)

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Device Identifier (DI) Information

KOWA FM-600
LSS50BK

KOWA COMPANY,LTD.
04987646804024
GS1
1
KOWA FM-600 is an instrument to measure the protein level contained in aqueous humor of the anterior chamber of human eye.
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Device Characteristics

Labeling does not contain MRI Safety Information
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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
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.
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FDA Product Code

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Product Code Product Code Name
MYC Ophthalmoscope,Laser,Scanning
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Sterilization

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Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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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
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Clinically Relevant Size

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

In Commercial Distribution
September 16, 2016

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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Secondary DI

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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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None
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Production Identifier(s) in UDI

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Customer Contact

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No Customer Contact currently defined
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