SCD® IIB

GUDID 05020583300026

SCD II Final Assembly

TERUMO BCT, INC.

Package sealing unit Package sealing unit Package sealing unit Package sealing unit Package sealing unit Package sealing unit Package sealing unit Package sealing unit Package sealing unit Package sealing unit Package sealing unit Package sealing unit Package sealing unit Package sealing unit Package sealing unit Package sealing unit Package sealing unit Package sealing unit Package sealing unit Package sealing unit Package sealing unit Package sealing unit Package sealing unit Package sealing unit Package sealing unit Package sealing unit Package sealing unit Package sealing unit Package sealing unit Package sealing unit Package sealing unit Package sealing unit Package sealing unit Package sealing unit Package sealing unit Package sealing unit Package sealing unit Package sealing unit Package sealing unit Package sealing unit Package sealing unit Package sealing unit Package sealing unit Package sealing unit Package sealing unit Package sealing unit 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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