SCD® IIB

GUDID 05020583300026

SCD II Final Assembly

TERUMO BCT, INC.

Package sealing unit

• Primary Device ID: 05020583300026
• NIH Device Record Key: 3dd4282f-57a9-45a2-8bce-7215a8d7db50
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SCD® IIB
• Version Model Number: 3NCC986
• 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: false
• 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
• 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

• Storage Environment Temperature: Between 2 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Protect from rain
• Storage Environment Temperature: Between 2 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Protect from rain
• Storage Environment Temperature: Between 2 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Protect from rain
• Storage Environment Temperature: Between 2 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Protect from rain
• Storage Environment Temperature: Between 2 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Protect from rain
• Storage Environment Temperature: Between 2 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Protect from rain
• Storage Environment Temperature: Between 2 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Protect from rain
• Storage Environment Temperature: Between 2 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Protect from rain
• Storage Environment Temperature: Between 2 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Protect from rain
• Storage Environment Temperature: Between 2 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Protect from rain
• Storage Environment Temperature: Between 2 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Protect from rain
• Storage Environment Temperature: Between 2 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Protect from rain
• Storage Environment Temperature: Between 2 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Protect from rain
• Storage Environment Temperature: Between 2 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Protect from rain
• Storage Environment Temperature: Between 2 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Protect from rain
• Storage Environment Temperature: Between 2 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Protect from rain
• Storage Environment Temperature: Between 2 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Protect from rain
• Storage Environment Temperature: Between 2 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Protect from rain
• Storage Environment Temperature: Between 2 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Protect from rain
• Storage Environment Temperature: Between 2 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Protect from rain
• Storage Environment Temperature: Between 2 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Protect from rain
• Storage Environment Temperature: Between 2 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Protect from rain
• Storage Environment Temperature: Between 2 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Protect from rain
• Storage Environment Temperature: Between 2 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Protect from rain
• Storage Environment Temperature: Between 2 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Protect from rain
• Storage Environment Temperature: Between 2 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Protect from rain
• Storage Environment Temperature: Between 2 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Protect from rain
• Storage Environment Temperature: Between 2 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Protect from rain
• Storage Environment Temperature: Between 2 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Protect from rain
• Storage Environment Temperature: Between 2 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Protect from rain
• Storage Environment Temperature: Between 2 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Protect from rain
• Storage Environment Temperature: Between 2 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Protect from rain
• Storage Environment Temperature: Between 2 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Protect from rain
• Storage Environment Temperature: Between 2 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Protect from rain
• Storage Environment Temperature: Between 2 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Protect from rain
• Storage Environment Temperature: Between 2 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Protect from rain
• Storage Environment Temperature: Between 2 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Protect from rain
• Storage Environment Temperature: Between 2 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Protect from rain
• Storage Environment Temperature: Between 2 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Protect from rain
• Storage Environment Temperature: Between 2 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Protect from rain
• Storage Environment Temperature: Between 2 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Protect from rain
• Storage Environment Temperature: Between 2 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Protect from rain
• Storage Environment Temperature: Between 2 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Protect from rain
• Storage Environment Temperature: Between 2 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Protect from rain
• Storage Environment Temperature: Between 2 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Protect from rain
• Storage Environment Temperature: Between 2 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Protect from rain
• Storage Environment Temperature: Between 2 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	05020583300026 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• BK860041

FDA Product Code

• KSB: SET, TRANSFER (BLOOD/PLASMA)

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-12-12
• Device Publish Date: 2016-09-15

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