SCD®-IIB

GUDID 05020583620025

SCD®-IIB Sterile Tubing Welder

TERUMO BCT, INC.

Package sealing unit

• Primary Device ID: 05020583620025
• NIH Device Record Key: f1501b88-b273-439c-8c18-d4116b136c0e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SCD®-IIB
• Version Model Number: 62002
• Company DUNS: 801679200
• Company Name: TERUMO BCT, INC.
• Device Count: 1
• DM Exempt: true
• 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: +1(303)205-2510
• Email: FDAUDIprogram@terumobct.com
• Phone: +1(303)205-2510
• Email: FDAUDIprogram@terumobct.com
• Phone: +1(303)205-2510
• Email: FDAUDIprogram@terumobct.com
• Phone: +1(303)205-2510
• Email: FDAUDIprogram@terumobct.com
• Phone: +1(303)205-2510
• Email: FDAUDIprogram@terumobct.com
• Phone: +1(303)205-2510
• Email: FDAUDIprogram@terumobct.com
• Phone: +1(303)205-2510
• Email: FDAUDIprogram@terumobct.com
• Phone: +1(303)205-2510
• Email: FDAUDIprogram@terumobct.com
• Phone: +1(303)205-2510
• Email: FDAUDIprogram@terumobct.com
• Phone: +1(303)205-2510
• Email: FDAUDIprogram@terumobct.com
• Phone: +1(303)205-2510
• Email: FDAUDIprogram@terumobct.com
• Phone: +1(303)205-2510
• 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
• 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 *Avoid Excessive Heat
• Special Storage Condition, Specify: Between 0 and 0 *Avoid Excessive Heat
• Special Storage Condition, Specify: Between 0 and 0 *Avoid Excessive Heat
• Special Storage Condition, Specify: Between 0 and 0 *Avoid Freezing
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid Excessive Heat
• Special Storage Condition, Specify: Between 0 and 0 *Avoid Freezing
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid Excessive Heat
• Special Storage Condition, Specify: Between 0 and 0 *Avoid Freezing
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid Excessive Heat
• Special Storage Condition, Specify: Between 0 and 0 *Avoid Freezing
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid Excessive Heat
• Special Storage Condition, Specify: Between 0 and 0 *Avoid Freezing
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid Excessive Heat
• Special Storage Condition, Specify: Between 0 and 0 *Avoid Freezing
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid Excessive Heat
• Special Storage Condition, Specify: Between 0 and 0 *Avoid Freezing
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid Excessive Heat
• Special Storage Condition, Specify: Between 0 and 0 *Avoid Freezing
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid Excessive Heat
• Special Storage Condition, Specify: Between 0 and 0 *Avoid Freezing
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid Excessive Heat
• Special Storage Condition, Specify: Between 0 and 0 *Avoid Freezing
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid Excessive Heat
• Special Storage Condition, Specify: Between 0 and 0 *Avoid Freezing
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid Excessive Heat
• Special Storage Condition, Specify: Between 0 and 0 *Avoid Freezing
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid Excessive Heat
• Special Storage Condition, Specify: Between 0 and 0 *Avoid Freezing
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid Excessive Heat
• Special Storage Condition, Specify: Between 0 and 0 *Avoid Freezing
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid Excessive Heat
• Special Storage Condition, Specify: Between 0 and 0 *Avoid Freezing
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid Excessive Heat
• Special Storage Condition, Specify: Between 0 and 0 *Avoid Freezing
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid Excessive Heat
• Special Storage Condition, Specify: Between 0 and 0 *Avoid Freezing
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid Excessive Heat
• Special Storage Condition, Specify: Between 0 and 0 *Avoid Freezing
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid Excessive Heat
• Special Storage Condition, Specify: Between 0 and 0 *Avoid Freezing
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid Excessive Heat
• Special Storage Condition, Specify: Between 0 and 0 *Avoid Freezing
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid Excessive Heat
• Special Storage Condition, Specify: Between 0 and 0 *Avoid Freezing
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid Excessive Heat
• Special Storage Condition, Specify: Between 0 and 0 *Avoid Freezing
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid Excessive Heat
• Special Storage Condition, Specify: Between 0 and 0 *Avoid Freezing
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid Excessive Heat
• Special Storage Condition, Specify: Between 0 and 0 *Avoid Freezing
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid Excessive Heat
• Special Storage Condition, Specify: Between 0 and 0 *Avoid Freezing
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid Excessive Heat
• Special Storage Condition, Specify: Between 0 and 0 *Avoid Freezing
• Special Storage Condition, Specify: Between 0 and 0 *Avoid Excessive Heat
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid Freezing
• Special Storage Condition, Specify: Between 0 and 0 *Avoid Excessive Heat
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid Freezing
• Special Storage Condition, Specify: Between 0 and 0 *Avoid Excessive Heat
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid Freezing
• Special Storage Condition, Specify: Between 0 and 0 *Avoid Excessive Heat
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid Freezing
• Special Storage Condition, Specify: Between 0 and 0 *Avoid Excessive Heat
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid Freezing
• Special Storage Condition, Specify: Between 0 and 0 *Avoid Excessive Heat
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid Freezing
• Special Storage Condition, Specify: Between 0 and 0 *Avoid Excessive Heat
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid Freezing
• Special Storage Condition, Specify: Between 0 and 0 *Avoid Excessive Heat
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid Freezing
• Special Storage Condition, Specify: Between 0 and 0 *Avoid Excessive Heat
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid Freezing
• Special Storage Condition, Specify: Between 0 and 0 *Avoid Excessive Heat
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid Freezing
• Special Storage Condition, Specify: Between 0 and 0 *Avoid Excessive Heat
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid Freezing
• Special Storage Condition, Specify: Between 0 and 0 *Avoid Excessive Heat
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid Freezing
• Special Storage Condition, Specify: Between 0 and 0 *Avoid Excessive Heat
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid Freezing
• Special Storage Condition, Specify: Between 0 and 0 *Avoid Excessive Heat
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid Freezing
• Special Storage Condition, Specify: Between 0 and 0 *Avoid Excessive Heat
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid Freezing
• Special Storage Condition, Specify: Between 0 and 0 *Avoid Excessive Heat
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid Freezing
• Special Storage Condition, Specify: Between 0 and 0 *Avoid Excessive Heat
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid Freezing
• Special Storage Condition, Specify: Between 0 and 0 *Avoid Excessive Heat
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid Freezing
• Special Storage Condition, Specify: Between 0 and 0 *Avoid Excessive Heat
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid Freezing
• Special Storage Condition, Specify: Between 0 and 0 *Avoid Excessive Heat
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid Freezing
• Special Storage Condition, Specify: Between 0 and 0 *Avoid Excessive Heat
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid Freezing
• Special Storage Condition, Specify: Between 0 and 0 *Avoid Excessive Heat
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid Freezing
• Special Storage Condition, Specify: Between 0 and 0 *Avoid Excessive Heat
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid Freezing
• Special Storage Condition, Specify: Between 0 and 0 *Avoid Excessive Heat
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid Freezing
• Special Storage Condition, Specify: Between 0 and 0 *Avoid Excessive Heat
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid Freezing
• Special Storage Condition, Specify: Between 0 and 0 *Avoid Excessive Heat
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid Freezing
• Special Storage Condition, Specify: Between 0 and 0 *Avoid Excessive Heat
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid Freezing
• Special Storage Condition, Specify: Between 0 and 0 *Avoid Excessive Heat
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid Freezing
• Special Storage Condition, Specify: Between 0 and 0 *Avoid Excessive Heat
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid Freezing
• Special Storage Condition, Specify: Between 0 and 0 *Avoid Excessive Heat
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid Freezing
• Special Storage Condition, Specify: Between 0 and 0 *Avoid Excessive Heat
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid Freezing
• Special Storage Condition, Specify: Between 0 and 0 *Avoid Excessive Heat
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid Freezing
• Special Storage Condition, Specify: Between 0 and 0 *Avoid Excessive Heat
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid Freezing
• Special Storage Condition, Specify: Between 0 and 0 *Avoid Excessive Heat
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	05020583620025 [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: 2017-09-15

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