EDG v4 347-404U

GUDID 04540778178113

ELECTRO DETACH GENERATOR v4 (Model: “EDG v4”) is used to detach the platinum coil from the pusher of i-ED COIL manufactured by Kaneka Corporation.

KANEKA CORPORATION

Vascular implant detacher, single-use, sterile

Primary Device ID	04540778178113
NIH Device Record Key	ade5b67a-b915-48e9-8a4f-040a8a62ec4b
Commercial Distribution Status	In Commercial Distribution
Brand Name	EDG v4
Version Model Number	347-404U
Catalog Number	347-404U
Company DUNS	690535406
Company Name	KANEKA CORPORATION
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Customer Support Contacts

Phone	(800) 526-3522
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Phone	(800) 526-3522
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Phone	(800) 526-3522
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Phone	(800) 526-3522
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Phone	(800) 526-3522
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Phone	(800) 526-3522
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Phone	(800) 526-3522
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Phone	(800) 526-3522
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Phone	(800) 526-3522
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Phone	(800) 526-3522
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Phone	(800) 526-3522
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Phone	(800) 526-3522
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Phone	(800) 526-3522
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Phone	(800) 526-3522
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Phone	(800) 526-3522
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Phone	(800) 526-3522
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Phone	(800) 526-3522
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Phone	(800) 526-3522
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Phone	(800) 526-3522
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Phone	(800) 526-3522
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Phone	(800) 526-3522
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Phone	(800) 526-3522
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Phone	(800) 526-3522
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Phone	(800) 526-3522
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Phone	(800) 526-3522
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Phone	(800) 526-3522
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Phone	(800) 526-3522
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Phone	(800) 526-3522
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Phone	(800) 526-3522
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Phone	(800) 526-3522
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Phone	(800) 526-3522
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Phone	(800) 526-3522
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Phone	(800) 526-3522
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Phone	(800) 526-3522
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Phone	(800) 526-3522
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Phone	(800) 526-3522
Email	xx@xx.xx

Device Dimensions

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Operating and Storage Conditions

Special Storage Condition, Specify	Between 0 and 0 *Store in a clean and cool place avoiding getting wet and direct sunlight, extreme temperature, or high humidity.
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between -10 Degrees Celsius and 60 Degrees Celsius
Handling Environment Temperature	Between 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Special Storage Condition, Specify	Between 0 and 0 *Store in a clean and cool place avoiding getting wet and direct sunlight, extreme temperature, or high humidity.
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between -10 Degrees Celsius and 60 Degrees Celsius
Handling Environment Temperature	Between 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Special Storage Condition, Specify	Between 0 and 0 *Store in a clean and cool place avoiding getting wet and direct sunlight, extreme temperature, or high humidity.
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between -10 Degrees Celsius and 60 Degrees Celsius
Handling Environment Temperature	Between 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Special Storage Condition, Specify	Between 0 and 0 *Store in a clean and cool place avoiding getting wet and direct sunlight, extreme temperature, or high humidity.
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between -10 Degrees Celsius and 60 Degrees Celsius
Handling Environment Temperature	Between 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Special Storage Condition, Specify	Between 0 and 0 *Store in a clean and cool place avoiding getting wet and direct sunlight, extreme temperature, or high humidity.
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between -10 Degrees Celsius and 60 Degrees Celsius
Handling Environment Temperature	Between 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Special Storage Condition, Specify	Between 0 and 0 *Store in a clean and cool place avoiding getting wet and direct sunlight, extreme temperature, or high humidity.
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between -10 Degrees Celsius and 60 Degrees Celsius
Handling Environment Temperature	Between 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Special Storage Condition, Specify	Between 0 and 0 *Store in a clean and cool place avoiding getting wet and direct sunlight, extreme temperature, or high humidity.
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between -10 Degrees Celsius and 60 Degrees Celsius
Handling Environment Temperature	Between 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Special Storage Condition, Specify	Between 0 and 0 *Store in a clean and cool place avoiding getting wet and direct sunlight, extreme temperature, or high humidity.
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between -10 Degrees Celsius and 60 Degrees Celsius
Handling Environment Temperature	Between 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Special Storage Condition, Specify	Between 0 and 0 *Store in a clean and cool place avoiding getting wet and direct sunlight, extreme temperature, or high humidity.
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between -10 Degrees Celsius and 60 Degrees Celsius
Handling Environment Temperature	Between 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Special Storage Condition, Specify	Between 0 and 0 *Store in a clean and cool place avoiding getting wet and direct sunlight, extreme temperature, or high humidity.
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between -10 Degrees Celsius and 60 Degrees Celsius
Handling Environment Temperature	Between 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Special Storage Condition, Specify	Between 0 and 0 *Store in a clean and cool place avoiding getting wet and direct sunlight, extreme temperature, or high humidity.
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between -10 Degrees Celsius and 60 Degrees Celsius
Handling Environment Temperature	Between 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Special Storage Condition, Specify	Between 0 and 0 *Store in a clean and cool place avoiding getting wet and direct sunlight, extreme temperature, or high humidity.
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between -10 Degrees Celsius and 60 Degrees Celsius
Handling Environment Temperature	Between 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Special Storage Condition, Specify	Between 0 and 0 *Store in a clean and cool place avoiding getting wet and direct sunlight, extreme temperature, or high humidity.
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between -10 Degrees Celsius and 60 Degrees Celsius
Handling Environment Temperature	Between 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Special Storage Condition, Specify	Between 0 and 0 *Store in a clean and cool place avoiding getting wet and direct sunlight, extreme temperature, or high humidity.
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between -10 Degrees Celsius and 60 Degrees Celsius
Handling Environment Temperature	Between 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Special Storage Condition, Specify	Between 0 and 0 *Store in a clean and cool place avoiding getting wet and direct sunlight, extreme temperature, or high humidity.
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between -10 Degrees Celsius and 60 Degrees Celsius
Handling Environment Temperature	Between 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Special Storage Condition, Specify	Between 0 and 0 *Store in a clean and cool place avoiding getting wet and direct sunlight, extreme temperature, or high humidity.
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between -10 Degrees Celsius and 60 Degrees Celsius
Handling Environment Temperature	Between 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Special Storage Condition, Specify	Between 0 and 0 *Store in a clean and cool place avoiding getting wet and direct sunlight, extreme temperature, or high humidity.
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between -10 Degrees Celsius and 60 Degrees Celsius
Handling Environment Temperature	Between 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Special Storage Condition, Specify	Between 0 and 0 *Store in a clean and cool place avoiding getting wet and direct sunlight, extreme temperature, or high humidity.
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between -10 Degrees Celsius and 60 Degrees Celsius
Handling Environment Temperature	Between 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Special Storage Condition, Specify	Between 0 and 0 *Store in a clean and cool place avoiding getting wet and direct sunlight, extreme temperature, or high humidity.
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between -10 Degrees Celsius and 60 Degrees Celsius
Handling Environment Temperature	Between 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Special Storage Condition, Specify	Between 0 and 0 *Store in a clean and cool place avoiding getting wet and direct sunlight, extreme temperature, or high humidity.
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between -10 Degrees Celsius and 60 Degrees Celsius
Handling Environment Temperature	Between 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Special Storage Condition, Specify	Between 0 and 0 *Store in a clean and cool place avoiding getting wet and direct sunlight, extreme temperature, or high humidity.
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between -10 Degrees Celsius and 60 Degrees Celsius
Handling Environment Temperature	Between 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Special Storage Condition, Specify	Between 0 and 0 *Store in a clean and cool place avoiding getting wet and direct sunlight, extreme temperature, or high humidity.
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between -10 Degrees Celsius and 60 Degrees Celsius
Handling Environment Temperature	Between 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Special Storage Condition, Specify	Between 0 and 0 *Store in a clean and cool place avoiding getting wet and direct sunlight, extreme temperature, or high humidity.
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between -10 Degrees Celsius and 60 Degrees Celsius
Handling Environment Temperature	Between 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Special Storage Condition, Specify	Between 0 and 0 *Store in a clean and cool place avoiding getting wet and direct sunlight, extreme temperature, or high humidity.
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between -10 Degrees Celsius and 60 Degrees Celsius
Handling Environment Temperature	Between 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Special Storage Condition, Specify	Between 0 and 0 *Store in a clean and cool place avoiding getting wet and direct sunlight, extreme temperature, or high humidity.
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between -10 Degrees Celsius and 60 Degrees Celsius
Handling Environment Temperature	Between 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Special Storage Condition, Specify	Between 0 and 0 *Store in a clean and cool place avoiding getting wet and direct sunlight, extreme temperature, or high humidity.
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between -10 Degrees Celsius and 60 Degrees Celsius
Handling Environment Temperature	Between 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Special Storage Condition, Specify	Between 0 and 0 *Store in a clean and cool place avoiding getting wet and direct sunlight, extreme temperature, or high humidity.
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between -10 Degrees Celsius and 60 Degrees Celsius
Handling Environment Temperature	Between 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Special Storage Condition, Specify	Between 0 and 0 *Store in a clean and cool place avoiding getting wet and direct sunlight, extreme temperature, or high humidity.
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between -10 Degrees Celsius and 60 Degrees Celsius
Handling Environment Temperature	Between 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Special Storage Condition, Specify	Between 0 and 0 *Store in a clean and cool place avoiding getting wet and direct sunlight, extreme temperature, or high humidity.
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between -10 Degrees Celsius and 60 Degrees Celsius
Handling Environment Temperature	Between 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Special Storage Condition, Specify	Between 0 and 0 *Store in a clean and cool place avoiding getting wet and direct sunlight, extreme temperature, or high humidity.
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between -10 Degrees Celsius and 60 Degrees Celsius
Handling Environment Temperature	Between 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Special Storage Condition, Specify	Between 0 and 0 *Store in a clean and cool place avoiding getting wet and direct sunlight, extreme temperature, or high humidity.
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between -10 Degrees Celsius and 60 Degrees Celsius
Handling Environment Temperature	Between 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Special Storage Condition, Specify	Between 0 and 0 *Store in a clean and cool place avoiding getting wet and direct sunlight, extreme temperature, or high humidity.
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between -10 Degrees Celsius and 60 Degrees Celsius
Handling Environment Temperature	Between 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Special Storage Condition, Specify	Between 0 and 0 *Store in a clean and cool place avoiding getting wet and direct sunlight, extreme temperature, or high humidity.
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between -10 Degrees Celsius and 60 Degrees Celsius
Handling Environment Temperature	Between 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Special Storage Condition, Specify	Between 0 and 0 *Store in a clean and cool place avoiding getting wet and direct sunlight, extreme temperature, or high humidity.
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between -10 Degrees Celsius and 60 Degrees Celsius
Handling Environment Temperature	Between 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Special Storage Condition, Specify	Between 0 and 0 *Store in a clean and cool place avoiding getting wet and direct sunlight, extreme temperature, or high humidity.
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between -10 Degrees Celsius and 60 Degrees Celsius
Handling Environment Temperature	Between 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Special Storage Condition, Specify	Between 0 and 0 *Store in a clean and cool place avoiding getting wet and direct sunlight, extreme temperature, or high humidity.
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between -10 Degrees Celsius and 60 Degrees Celsius
Handling Environment Temperature	Between 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Special Storage Condition, Specify	Between 0 and 0 *Store in a clean and cool place avoiding getting wet and direct sunlight, extreme temperature, or high humidity.
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between -10 Degrees Celsius and 60 Degrees Celsius
Handling Environment Temperature	Between 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Special Storage Condition, Specify	Between 0 and 0 *Store in a clean and cool place avoiding getting wet and direct sunlight, extreme temperature, or high humidity.
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between -10 Degrees Celsius and 60 Degrees Celsius
Handling Environment Temperature	Between 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Special Storage Condition, Specify	Between 0 and 0 *Store in a clean and cool place avoiding getting wet and direct sunlight, extreme temperature, or high humidity.
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between -10 Degrees Celsius and 60 Degrees Celsius
Handling Environment Temperature	Between 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Special Storage Condition, Specify	Between 0 and 0 *Store in a clean and cool place avoiding getting wet and direct sunlight, extreme temperature, or high humidity.
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between -10 Degrees Celsius and 60 Degrees Celsius
Handling Environment Temperature	Between 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Special Storage Condition, Specify	Between 0 and 0 *Store in a clean and cool place avoiding getting wet and direct sunlight, extreme temperature, or high humidity.
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between -10 Degrees Celsius and 60 Degrees Celsius
Handling Environment Temperature	Between 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Special Storage Condition, Specify	Between 0 and 0 *Store in a clean and cool place avoiding getting wet and direct sunlight, extreme temperature, or high humidity.
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between -10 Degrees Celsius and 60 Degrees Celsius
Handling Environment Temperature	Between 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Special Storage Condition, Specify	Between 0 and 0 *Store in a clean and cool place avoiding getting wet and direct sunlight, extreme temperature, or high humidity.
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between -10 Degrees Celsius and 60 Degrees Celsius
Handling Environment Temperature	Between 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Special Storage Condition, Specify	Between 0 and 0 *Store in a clean and cool place avoiding getting wet and direct sunlight, extreme temperature, or high humidity.
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between -10 Degrees Celsius and 60 Degrees Celsius
Handling Environment Temperature	Between 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Special Storage Condition, Specify	Between 0 and 0 *Store in a clean and cool place avoiding getting wet and direct sunlight, extreme temperature, or high humidity.
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between -10 Degrees Celsius and 60 Degrees Celsius
Handling Environment Temperature	Between 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Special Storage Condition, Specify	Between 0 and 0 *Store in a clean and cool place avoiding getting wet and direct sunlight, extreme temperature, or high humidity.
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between -10 Degrees Celsius and 60 Degrees Celsius
Handling Environment Temperature	Between 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Special Storage Condition, Specify	Between 0 and 0 *Store in a clean and cool place avoiding getting wet and direct sunlight, extreme temperature, or high humidity.
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between -10 Degrees Celsius and 60 Degrees Celsius
Handling Environment Temperature	Between 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Special Storage Condition, Specify	Between 0 and 0 *Store in a clean and cool place avoiding getting wet and direct sunlight, extreme temperature, or high humidity.
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between -10 Degrees Celsius and 60 Degrees Celsius
Handling Environment Temperature	Between 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Special Storage Condition, Specify	Between 0 and 0 *Store in a clean and cool place avoiding getting wet and direct sunlight, extreme temperature, or high humidity.
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between -10 Degrees Celsius and 60 Degrees Celsius
Handling Environment Temperature	Between 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Special Storage Condition, Specify	Between 0 and 0 *Store in a clean and cool place avoiding getting wet and direct sunlight, extreme temperature, or high humidity.
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between -10 Degrees Celsius and 60 Degrees Celsius
Handling Environment Temperature	Between 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Special Storage Condition, Specify	Between 0 and 0 *Store in a clean and cool place avoiding getting wet and direct sunlight, extreme temperature, or high humidity.
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between -10 Degrees Celsius and 60 Degrees Celsius
Handling Environment Temperature	Between 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Special Storage Condition, Specify	Between 0 and 0 *Store in a clean and cool place avoiding getting wet and direct sunlight, extreme temperature, or high humidity.
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between -10 Degrees Celsius and 60 Degrees Celsius
Handling Environment Temperature	Between 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Special Storage Condition, Specify	Between 0 and 0 *Store in a clean and cool place avoiding getting wet and direct sunlight, extreme temperature, or high humidity.
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between -10 Degrees Celsius and 60 Degrees Celsius
Handling Environment Temperature	Between 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Special Storage Condition, Specify	Between 0 and 0 *Store in a clean and cool place avoiding getting wet and direct sunlight, extreme temperature, or high humidity.
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between -10 Degrees Celsius and 60 Degrees Celsius
Handling Environment Temperature	Between 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Special Storage Condition, Specify	Between 0 and 0 *Store in a clean and cool place avoiding getting wet and direct sunlight, extreme temperature, or high humidity.
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between -10 Degrees Celsius and 60 Degrees Celsius
Handling Environment Temperature	Between 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Special Storage Condition, Specify	Between 0 and 0 *Store in a clean and cool place avoiding getting wet and direct sunlight, extreme temperature, or high humidity.
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between -10 Degrees Celsius and 60 Degrees Celsius
Handling Environment Temperature	Between 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Special Storage Condition, Specify	Between 0 and 0 *Store in a clean and cool place avoiding getting wet and direct sunlight, extreme temperature, or high humidity.
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between -10 Degrees Celsius and 60 Degrees Celsius
Handling Environment Temperature	Between 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Special Storage Condition, Specify	Between 0 and 0 *Store in a clean and cool place avoiding getting wet and direct sunlight, extreme temperature, or high humidity.
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between -10 Degrees Celsius and 60 Degrees Celsius
Handling Environment Temperature	Between 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Special Storage Condition, Specify	Between 0 and 0 *Store in a clean and cool place avoiding getting wet and direct sunlight, extreme temperature, or high humidity.
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between -10 Degrees Celsius and 60 Degrees Celsius
Handling Environment Temperature	Between 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Special Storage Condition, Specify	Between 0 and 0 *Store in a clean and cool place avoiding getting wet and direct sunlight, extreme temperature, or high humidity.
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between -10 Degrees Celsius and 60 Degrees Celsius
Handling Environment Temperature	Between 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Special Storage Condition, Specify	Between 0 and 0 *Store in a clean and cool place avoiding getting wet and direct sunlight, extreme temperature, or high humidity.
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between -10 Degrees Celsius and 60 Degrees Celsius
Handling Environment Temperature	Between 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Special Storage Condition, Specify	Between 0 and 0 *Store in a clean and cool place avoiding getting wet and direct sunlight, extreme temperature, or high humidity.
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between -10 Degrees Celsius and 60 Degrees Celsius
Handling Environment Temperature	Between 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Special Storage Condition, Specify	Between 0 and 0 *Store in a clean and cool place avoiding getting wet and direct sunlight, extreme temperature, or high humidity.
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between -10 Degrees Celsius and 60 Degrees Celsius
Handling Environment Temperature	Between 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Special Storage Condition, Specify	Between 0 and 0 *Store in a clean and cool place avoiding getting wet and direct sunlight, extreme temperature, or high humidity.
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between -10 Degrees Celsius and 60 Degrees Celsius
Handling Environment Temperature	Between 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Special Storage Condition, Specify	Between 0 and 0 *Store in a clean and cool place avoiding getting wet and direct sunlight, extreme temperature, or high humidity.
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between -10 Degrees Celsius and 60 Degrees Celsius
Handling Environment Temperature	Between 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Special Storage Condition, Specify	Between 0 and 0 *Store in a clean and cool place avoiding getting wet and direct sunlight, extreme temperature, or high humidity.
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between -10 Degrees Celsius and 60 Degrees Celsius
Handling Environment Temperature	Between 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Special Storage Condition, Specify	Between 0 and 0 *Store in a clean and cool place avoiding getting wet and direct sunlight, extreme temperature, or high humidity.
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between -10 Degrees Celsius and 60 Degrees Celsius
Handling Environment Temperature	Between 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Special Storage Condition, Specify	Between 0 and 0 *Store in a clean and cool place avoiding getting wet and direct sunlight, extreme temperature, or high humidity.
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between -10 Degrees Celsius and 60 Degrees Celsius
Handling Environment Temperature	Between 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Special Storage Condition, Specify	Between 0 and 0 *Store in a clean and cool place avoiding getting wet and direct sunlight, extreme temperature, or high humidity.
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between -10 Degrees Celsius and 60 Degrees Celsius
Handling Environment Temperature	Between 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Special Storage Condition, Specify	Between 0 and 0 *Store in a clean and cool place avoiding getting wet and direct sunlight, extreme temperature, or high humidity.
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between -10 Degrees Celsius and 60 Degrees Celsius
Handling Environment Temperature	Between 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal

Device Identifiers

Device Issuing Agency	Device ID
GS1	04540778178113 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K192068

FDA Product Code

KRD	Device, Vascular, For Promoting Embolization

Sterilization

Steralize Prior To Use	false
Device Is Sterile	true

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2020-07-08
Device Publish Date	2020-06-30

Devices Manufactured by KANEKA CORPORATION

04540778177291 - i-ED COIL	2024-11-04 The i-ED COIL is used for vascular embolization with a platinum coil at the target lesion in the patient’s blood vessel.
04540778190412 - i-ED COIL	2024-11-04 The i-ED COIL is used for vascular embolization with a platinum coil at the target lesion in the patient’s blood vessel.
04540778190429 - i-ED COIL	2024-11-04 The i-ED COIL is used for vascular embolization with a platinum coil at the target lesion in the patient’s blood vessel.
24993478010049 - LIXELLE	2024-11-04 The Lixelle(r) beta 2-microglobulin apheresis column is indicated for the treatment of patients with clinically-diagnosed dialys
04993478010052 - LIXELLE	2024-11-04 The Lixelle(r) beta 2-microglobulin apheresis column is indicated for the treatment of patients with clinically-diagnosed dialys
04993478010069 - LIXELLE	2024-11-04 The Lixelle(r) beta 2-microglobulin apheresis column is indicated for the treatment of patients with clinically-diagnosed dialys
04540778176485 - i-ED COIL	2023-08-04 The i-ED COIL is used for vascular embolization with a platinum coil at the target lesion in the patient’s blood vessel.
04540778176423 - i-ED COIL	2022-06-07 The i-ED COIL is used for vascular embolization with a platinum coil at the target lesion in the patient’s blood vessel.