Rika Plasma Separation Set

GUDID 35020583212009

elabeling.terumobct.com

TERUMO BCT, INC.

Apheresis kit

• Primary Device ID: 35020583212009
• NIH Device Record Key: be1dadc8-b373-49c4-acb7-d85ec8e24d4d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Rika Plasma Separation Set
• Version Model Number: 21200
• 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: 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

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• Phone: +1(877)339-4228
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• Phone: +1(877)339-4228
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• Phone: +1(877)339-4228
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• Phone: +1(877)339-4228
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• Phone: +1(877)339-4228
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• Phone: +1(877)339-4228
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• Phone: +1(877)339-4228
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• 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
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Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Protect from Sun (set level)
• Special Storage Condition, Specify: Between 0 and 0 *Fragile (box level)
• Handling Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry (box and set level)
• Special Storage Condition, Specify: Between 0 and 0 *Protect from Sun (set level)
• Special Storage Condition, Specify: Between 0 and 0 *Fragile (box level)
• Handling Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry (box and set level)
• Special Storage Condition, Specify: Between 0 and 0 *Protect from Sun (set level)
• Special Storage Condition, Specify: Between 0 and 0 *Fragile (box level)
• Handling Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry (box and set level)
• Special Storage Condition, Specify: Between 0 and 0 *Protect from Sun (set level)
• Special Storage Condition, Specify: Between 0 and 0 *Fragile (box level)
• Handling Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry (box and set level)
• Special Storage Condition, Specify: Between 0 and 0 *Protect from Sun (set level)
• Special Storage Condition, Specify: Between 0 and 0 *Fragile (box level)
• Handling Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry (box and set level)
• Special Storage Condition, Specify: Between 0 and 0 *Protect from Sun (set level)
• Special Storage Condition, Specify: Between 0 and 0 *Fragile (box level)
• Handling Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry (box and set level)
• Special Storage Condition, Specify: Between 0 and 0 *Protect from Sun (set level)
• Special Storage Condition, Specify: Between 0 and 0 *Fragile (box level)
• Handling Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry (box and set level)
• Special Storage Condition, Specify: Between 0 and 0 *Protect from Sun (set level)
• Special Storage Condition, Specify: Between 0 and 0 *Fragile (box level)
• Handling Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry (box and set level)
• Special Storage Condition, Specify: Between 0 and 0 *Protect from Sun (set level)
• Special Storage Condition, Specify: Between 0 and 0 *Fragile (box level)
• Handling Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry (box and set level)
• Special Storage Condition, Specify: Between 0 and 0 *Protect from Sun (set level)
• Special Storage Condition, Specify: Between 0 and 0 *Fragile (box level)
• Handling Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry (box and set level)
• Special Storage Condition, Specify: Between 0 and 0 *Protect from Sun (set level)
• Special Storage Condition, Specify: Between 0 and 0 *Fragile (box level)
• Handling Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry (box and set level)
• Special Storage Condition, Specify: Between 0 and 0 *Protect from Sun (set level)
• Special Storage Condition, Specify: Between 0 and 0 *Fragile (box level)
• Handling Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry (box and set level)
• Special Storage Condition, Specify: Between 0 and 0 *Protect from Sun (set level)
• Special Storage Condition, Specify: Between 0 and 0 *Fragile (box level)
• Handling Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry (box and set level)
• Special Storage Condition, Specify: Between 0 and 0 *Protect from Sun (set level)
• Special Storage Condition, Specify: Between 0 and 0 *Fragile (box level)
• Handling Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry (box and set level)
• Special Storage Condition, Specify: Between 0 and 0 *Protect from Sun (set level)
• Special Storage Condition, Specify: Between 0 and 0 *Fragile (box level)
• Handling Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry (box and set level)
• Special Storage Condition, Specify: Between 0 and 0 *Protect from Sun (set level)
• Special Storage Condition, Specify: Between 0 and 0 *Fragile (box level)
• Handling Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry (box and set level)
• Special Storage Condition, Specify: Between 0 and 0 *Protect from Sun (set level)
• Special Storage Condition, Specify: Between 0 and 0 *Fragile (box level)
• Handling Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry (box and set level)
• Special Storage Condition, Specify: Between 0 and 0 *Protect from Sun (set level)
• Special Storage Condition, Specify: Between 0 and 0 *Fragile (box level)
• Handling Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry (box and set level)
• Special Storage Condition, Specify: Between 0 and 0 *Protect from Sun (set level)
• Special Storage Condition, Specify: Between 0 and 0 *Fragile (box level)
• Handling Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry (box and set level)
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry (box and set level)
• Handling Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from Sun (set level)
• Special Storage Condition, Specify: Between 0 and 0 *Fragile (box level)
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry (box and set level)
• Handling Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from Sun (set level)
• Special Storage Condition, Specify: Between 0 and 0 *Fragile (box level)
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry (box and set level)
• Handling Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from Sun (set level)
• Special Storage Condition, Specify: Between 0 and 0 *Fragile (box level)
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry (box and set level)
• Handling Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from Sun (set level)
• Special Storage Condition, Specify: Between 0 and 0 *Fragile (box level)
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry (box and set level)
• Handling Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from Sun (set level)
• Special Storage Condition, Specify: Between 0 and 0 *Fragile (box level)
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry (box and set level)
• Handling Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from Sun (set level)
• Special Storage Condition, Specify: Between 0 and 0 *Fragile (box level)
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry (box and set level)
• Handling Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from Sun (set level)
• Special Storage Condition, Specify: Between 0 and 0 *Fragile (box level)
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry (box and set level)
• Handling Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from Sun (set level)
• Special Storage Condition, Specify: Between 0 and 0 *Fragile (box level)
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry (box and set level)
• Handling Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from Sun (set level)
• Special Storage Condition, Specify: Between 0 and 0 *Fragile (box level)
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry (box and set level)
• Handling Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from Sun (set level)
• Special Storage Condition, Specify: Between 0 and 0 *Fragile (box level)
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry (box and set level)
• Handling Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from Sun (set level)
• Special Storage Condition, Specify: Between 0 and 0 *Fragile (box level)
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry (box and set level)
• Handling Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from Sun (set level)
• Special Storage Condition, Specify: Between 0 and 0 *Fragile (box level)
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry (box and set level)
• Handling Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from Sun (set level)
• Special Storage Condition, Specify: Between 0 and 0 *Fragile (box level)
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry (box and set level)
• Handling Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from Sun (set level)
• Special Storage Condition, Specify: Between 0 and 0 *Fragile (box level)
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry (box and set level)
• Handling Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from Sun (set level)
• Special Storage Condition, Specify: Between 0 and 0 *Fragile (box level)
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry (box and set level)
• Handling Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from Sun (set level)
• Special Storage Condition, Specify: Between 0 and 0 *Fragile (box level)
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry (box and set level)
• Handling Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from Sun (set level)
• Special Storage Condition, Specify: Between 0 and 0 *Fragile (box level)
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry (box and set level)
• Handling Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from Sun (set level)
• Special Storage Condition, Specify: Between 0 and 0 *Fragile (box level)
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry (box and set level)
• Handling Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from Sun (set level)
• Special Storage Condition, Specify: Between 0 and 0 *Fragile (box level)
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry (box and set level)
• Handling Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from Sun (set level)
• Special Storage Condition, Specify: Between 0 and 0 *Fragile (box level)
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry (box and set level)
• Handling Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from Sun (set level)
• Special Storage Condition, Specify: Between 0 and 0 *Fragile (box level)
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry (box and set level)
• Handling Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from Sun (set level)
• Special Storage Condition, Specify: Between 0 and 0 *Fragile (box level)
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry (box and set level)
• Handling Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from Sun (set level)
• Special Storage Condition, Specify: Between 0 and 0 *Fragile (box level)
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry (box and set level)
• Handling Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from Sun (set level)
• Special Storage Condition, Specify: Between 0 and 0 *Fragile (box level)
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry (box and set level)
• Handling Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from Sun (set level)
• Special Storage Condition, Specify: Between 0 and 0 *Fragile (box level)
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry (box and set level)
• Handling Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from Sun (set level)
• Special Storage Condition, Specify: Between 0 and 0 *Fragile (box level)
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry (box and set level)
• Handling Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from Sun (set level)
• Special Storage Condition, Specify: Between 0 and 0 *Fragile (box level)
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry (box and set level)
• Handling Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from Sun (set level)
• Special Storage Condition, Specify: Between 0 and 0 *Fragile (box level)
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry (box and set level)
• Handling Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from Sun (set level)
• Special Storage Condition, Specify: Between 0 and 0 *Fragile (box level)
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry (box and set level)
• Handling Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from Sun (set level)
• Special Storage Condition, Specify: Between 0 and 0 *Fragile (box level)
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry (box and set level)
• Handling Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from Sun (set level)
• Special Storage Condition, Specify: Between 0 and 0 *Fragile (box level)
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry (box and set level)
• Handling Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from Sun (set level)
• Special Storage Condition, Specify: Between 0 and 0 *Fragile (box level)
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry (box and set level)
• Handling Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from Sun (set level)
• Special Storage Condition, Specify: Between 0 and 0 *Fragile (box level)
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry (box and set level)
• Handling Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from Sun (set level)
• Special Storage Condition, Specify: Between 0 and 0 *Fragile (box level)

Device Identifiers

Device Issuing Agency	Device ID
GS1	05020583212008 [Primary]
GS1	35020583212009 [Package]; Contains: 05020583212008; Package: [34 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: true

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

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