Rika Plasma Donation System

GUDID 05020583420007

elabeling.terumobct.com

TERUMO BCT, INC.

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• Primary Device ID: 05020583420007
• NIH Device Record Key: a69f6807-0adb-4844-8b91-62fdf82b8498
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Rika Plasma Donation System
• Version Model Number: 42000
• Company DUNS: 801679200
• Company Name: TERUMO BCT, INC.
• 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(877)339-4228
• Email: FDAUDIprogram@terumobct.com
• Phone: +1(877)339-4228
• Email: FDAUDIprogram@terumobct.com
• Phone: +1(877)339-4228
• Email: FDAUDIprogram@terumobct.com
• Phone: +1(877)339-4228
• Email: FDAUDIprogram@terumobct.com
• Phone: +1(877)339-4228
• Email: FDAUDIprogram@terumobct.com
• Phone: +1(877)339-4228
• Email: FDAUDIprogram@terumobct.com
• Phone: +1(877)339-4228
• Email: FDAUDIprogram@terumobct.com
• Phone: +1(877)339-4228
• Email: FDAUDIprogram@terumobct.com
• Phone: +1(877)339-4228
• Email: FDAUDIprogram@terumobct.com
• Phone: +1(877)339-4228
• Email: FDAUDIprogram@terumobct.com
• Phone: +1(877)339-4228
• Email: FDAUDIprogram@terumobct.com
• Phone: +1(877)339-4228
• Email: FDAUDIprogram@terumobct.com
• Phone: +1(877)339-4228
• Email: FDAUDIprogram@terumobct.com
• Phone: +1(877)339-4228
• Email: FDAUDIprogram@terumobct.com
• Phone: +1(877)339-4228
• Email: FDAUDIprogram@terumobct.com
• Phone: +1(877)339-4228
• Email: FDAUDIprogram@terumobct.com
• Phone: +1(877)339-4228
• Email: FDAUDIprogram@terumobct.com
• Phone: +1(877)339-4228
• Email: FDAUDIprogram@terumobct.com
• Phone: +1(877)339-4228
• Email: FDAUDIprogram@terumobct.com
• Phone: +1(877)339-4228
• Email: FDAUDIprogram@terumobct.com
• Phone: +1(877)339-4228
• Email: FDAUDIprogram@terumobct.com
• Phone: +1(877)339-4228
• Email: FDAUDIprogram@terumobct.com
• Phone: +1(877)339-4228
• Email: FDAUDIprogram@terumobct.com
• Phone: +1(877)339-4228
• Email: FDAUDIprogram@terumobct.com
• Phone: +1(877)339-4228
• Email: FDAUDIprogram@terumobct.com
• Phone: +1(877)339-4228
• Email: FDAUDIprogram@terumobct.com
• Phone: +1(877)339-4228
• Email: FDAUDIprogram@terumobct.com
• Phone: +1(877)339-4228
• Email: FDAUDIprogram@terumobct.com
• Phone: +1(877)339-4228
• Email: FDAUDIprogram@terumobct.com
• Phone: +1(877)339-4228
• Email: FDAUDIprogram@terumobct.com
• Phone: +1(877)339-4228
• Email: FDAUDIprogram@terumobct.com
• Phone: +1(877)339-4228
• Email: FDAUDIprogram@terumobct.com
• Phone: +1(877)339-4228
• Email: FDAUDIprogram@terumobct.com
• Phone: +1(877)339-4228
• Email: FDAUDIprogram@terumobct.com
• Phone: +1(877)339-4228
• Email: FDAUDIprogram@terumobct.com
• Phone: +1(877)339-4228
• Email: FDAUDIprogram@terumobct.com
• Phone: +1(877)339-4228
• Email: FDAUDIprogram@terumobct.com
• Phone: +1(877)339-4228
• Email: FDAUDIprogram@terumobct.com
• Phone: +1(877)339-4228
• Email: FDAUDIprogram@terumobct.com
• Phone: +1(877)339-4228
• Email: FDAUDIprogram@terumobct.com
• Phone: +1(877)339-4228
• Email: FDAUDIprogram@terumobct.com
• Phone: +1(877)339-4228
• Email: FDAUDIprogram@terumobct.com
• Phone: +1(877)339-4228
• Email: FDAUDIprogram@terumobct.com
• Phone: +1(877)339-4228
• Email: FDAUDIprogram@terumobct.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Fragile (Box Level)
• Handling Environment Atmospheric Pressure: Between 54.8 KiloPascal and 108.4 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry (Box Level)
• Special Storage Condition, Specify: Between 0 and 0 *Fragile (Box Level)
• Handling Environment Atmospheric Pressure: Between 54.8 KiloPascal and 108.4 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry (Box Level)
• Special Storage Condition, Specify: Between 0 and 0 *Fragile (Box Level)
• Handling Environment Atmospheric Pressure: Between 54.8 KiloPascal and 108.4 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry (Box Level)
• Special Storage Condition, Specify: Between 0 and 0 *Fragile (Box Level)
• Handling Environment Atmospheric Pressure: Between 54.8 KiloPascal and 108.4 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry (Box Level)
• Special Storage Condition, Specify: Between 0 and 0 *Fragile (Box Level)
• Handling Environment Atmospheric Pressure: Between 54.8 KiloPascal and 108.4 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry (Box Level)
• Special Storage Condition, Specify: Between 0 and 0 *Fragile (Box Level)
• Handling Environment Atmospheric Pressure: Between 54.8 KiloPascal and 108.4 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry (Box Level)
• Special Storage Condition, Specify: Between 0 and 0 *Fragile (Box Level)
• Handling Environment Atmospheric Pressure: Between 54.8 KiloPascal and 108.4 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry (Box Level)
• Special Storage Condition, Specify: Between 0 and 0 *Fragile (Box Level)
• Handling Environment Atmospheric Pressure: Between 54.8 KiloPascal and 108.4 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry (Box Level)
• Special Storage Condition, Specify: Between 0 and 0 *Fragile (Box Level)
• Handling Environment Atmospheric Pressure: Between 54.8 KiloPascal and 108.4 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry (Box Level)
• Special Storage Condition, Specify: Between 0 and 0 *Fragile (Box Level)
• Handling Environment Atmospheric Pressure: Between 54.8 KiloPascal and 108.4 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry (Box Level)
• Special Storage Condition, Specify: Between 0 and 0 *Fragile (Box Level)
• Handling Environment Atmospheric Pressure: Between 54.8 KiloPascal and 108.4 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry (Box Level)
• Special Storage Condition, Specify: Between 0 and 0 *Fragile (Box Level)
• Handling Environment Atmospheric Pressure: Between 54.8 KiloPascal and 108.4 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry (Box Level)
• Special Storage Condition, Specify: Between 0 and 0 *Fragile (Box Level)
• Handling Environment Atmospheric Pressure: Between 54.8 KiloPascal and 108.4 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry (Box Level)
• Special Storage Condition, Specify: Between 0 and 0 *Fragile (Box Level)
• Handling Environment Atmospheric Pressure: Between 54.8 KiloPascal and 108.4 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry (Box Level)
• Special Storage Condition, Specify: Between 0 and 0 *Fragile (Box Level)
• Handling Environment Atmospheric Pressure: Between 54.8 KiloPascal and 108.4 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry (Box Level)
• Special Storage Condition, Specify: Between 0 and 0 *Fragile (Box Level)
• Handling Environment Atmospheric Pressure: Between 54.8 KiloPascal and 108.4 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry (Box Level)
• Special Storage Condition, Specify: Between 0 and 0 *Fragile (Box Level)
• Handling Environment Atmospheric Pressure: Between 54.8 KiloPascal and 108.4 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry (Box Level)
• Special Storage Condition, Specify: Between 0 and 0 *Fragile (Box Level)
• Handling Environment Atmospheric Pressure: Between 54.8 KiloPascal and 108.4 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry (Box Level)
• Special Storage Condition, Specify: Between 0 and 0 *Fragile (Box Level)
• Handling Environment Atmospheric Pressure: Between 54.8 KiloPascal and 108.4 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry (Box Level)
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile (Box Level)
• Handling Environment Atmospheric Pressure: Between 54.8 KiloPascal and 108.4 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry (Box Level)
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile (Box Level)
• Handling Environment Atmospheric Pressure: Between 54.8 KiloPascal and 108.4 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry (Box Level)
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile (Box Level)
• Handling Environment Atmospheric Pressure: Between 54.8 KiloPascal and 108.4 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry (Box Level)
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile (Box Level)
• Handling Environment Atmospheric Pressure: Between 54.8 KiloPascal and 108.4 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry (Box Level)
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile (Box Level)
• Handling Environment Atmospheric Pressure: Between 54.8 KiloPascal and 108.4 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry (Box Level)
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile (Box Level)
• Handling Environment Atmospheric Pressure: Between 54.8 KiloPascal and 108.4 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry (Box Level)
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile (Box Level)
• Handling Environment Atmospheric Pressure: Between 54.8 KiloPascal and 108.4 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry (Box Level)
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile (Box Level)
• Handling Environment Atmospheric Pressure: Between 54.8 KiloPascal and 108.4 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry (Box Level)
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile (Box Level)
• Handling Environment Atmospheric Pressure: Between 54.8 KiloPascal and 108.4 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry (Box Level)
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile (Box Level)
• Handling Environment Atmospheric Pressure: Between 54.8 KiloPascal and 108.4 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry (Box Level)
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile (Box Level)
• Handling Environment Atmospheric Pressure: Between 54.8 KiloPascal and 108.4 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry (Box Level)
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile (Box Level)
• Handling Environment Atmospheric Pressure: Between 54.8 KiloPascal and 108.4 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry (Box Level)
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile (Box Level)
• Handling Environment Atmospheric Pressure: Between 54.8 KiloPascal and 108.4 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry (Box Level)
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile (Box Level)
• Handling Environment Atmospheric Pressure: Between 54.8 KiloPascal and 108.4 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry (Box Level)
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile (Box Level)
• Handling Environment Atmospheric Pressure: Between 54.8 KiloPascal and 108.4 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry (Box Level)
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile (Box Level)
• Handling Environment Atmospheric Pressure: Between 54.8 KiloPascal and 108.4 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry (Box Level)
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile (Box Level)
• Handling Environment Atmospheric Pressure: Between 54.8 KiloPascal and 108.4 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry (Box Level)
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile (Box Level)
• Handling Environment Atmospheric Pressure: Between 54.8 KiloPascal and 108.4 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry (Box Level)
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile (Box Level)
• Handling Environment Atmospheric Pressure: Between 54.8 KiloPascal and 108.4 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry (Box Level)
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile (Box Level)
• Handling Environment Atmospheric Pressure: Between 54.8 KiloPascal and 108.4 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry (Box Level)
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile (Box Level)
• Handling Environment Atmospheric Pressure: Between 54.8 KiloPascal and 108.4 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry (Box Level)
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile (Box Level)
• Handling Environment Atmospheric Pressure: Between 54.8 KiloPascal and 108.4 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry (Box Level)
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile (Box Level)
• Handling Environment Atmospheric Pressure: Between 54.8 KiloPascal and 108.4 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry (Box Level)
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile (Box Level)
• Handling Environment Atmospheric Pressure: Between 54.8 KiloPascal and 108.4 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry (Box Level)
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile (Box Level)
• Handling Environment Atmospheric Pressure: Between 54.8 KiloPascal and 108.4 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry (Box Level)
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile (Box Level)
• Handling Environment Atmospheric Pressure: Between 54.8 KiloPascal and 108.4 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry (Box Level)
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile (Box Level)
• Handling Environment Atmospheric Pressure: Between 54.8 KiloPascal and 108.4 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry (Box Level)
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile (Box Level)
• Handling Environment Atmospheric Pressure: Between 54.8 KiloPascal and 108.4 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry (Box Level)
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile (Box Level)
• Handling Environment Atmospheric Pressure: Between 54.8 KiloPascal and 108.4 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry (Box Level)
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile (Box Level)
• Handling Environment Atmospheric Pressure: Between 54.8 KiloPascal and 108.4 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry (Box Level)
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile (Box Level)
• Handling Environment Atmospheric Pressure: Between 54.8 KiloPascal and 108.4 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry (Box Level)
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile (Box Level)
• Handling Environment Atmospheric Pressure: Between 54.8 KiloPascal and 108.4 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry (Box Level)
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile (Box Level)
• Handling Environment Atmospheric Pressure: Between 54.8 KiloPascal and 108.4 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry (Box Level)
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile (Box Level)
• Handling Environment Atmospheric Pressure: Between 54.8 KiloPascal and 108.4 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry (Box Level)

Device Identifiers

Device Issuing Agency	Device ID
GS1	05020583420007 [Primary]
GS1	35020583420008 [Package]; Package: [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• BK210635

FDA Product Code

• GKT: Separator, Automated, Blood Cell, Diagnostic

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-07-21
• Device Publish Date: 2022-07-13

Devices Manufactured by TERUMO BCT, INC.

• 35020583826503 - Trima Accel: 2023-06-27 Trima Accel® LRS® Platelet, Plasma, Auto RBC Set
• 05020583910003 - COBE® 2991: 2023-06-27 Blood Cell Processor
• 05020583419506 - IMUGARD: 2022-12-01 elabeling.terumobct.com
• 35020583700315 - Accessory Platelet Bag with Integrated Sampler: 2022-12-01 elabeling.terumobct.com
• 05020583112209 - Spectra Optia®: 2022-09-01 Single-Needle Connector
• 05020583122208 - Spectra Optia®: 2022-09-01 Exchange Sets
• 05020583700703 - Platelet Additive Solution Connection Adapter: 2022-09-01 PLATELET ADDITIVE SOLUTION CONNECTION ADAPTER
• 05020583705005 - COBE® Spectra: 2022-09-01 Therapeutic Plasma Exchange Set