SCD Welding Wafer

GUDID 55020583260318

3-NCC987 SCD Wafer

TERUMO BCT, INC.

Package sealing unit

• Primary Device ID: 55020583260318
• NIH Device Record Key: e070c8bc-93a5-4dca-b080-12e3f69462a1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SCD Welding Wafer
• Version Model Number: 3NCC987
• Company DUNS: 801679200
• Company Name: TERUMO BCT, INC.
• Device Count: 70
• 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: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• 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

Operating and Storage Conditions

• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 54 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 54 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 54 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 54 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 54 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 54 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 54 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 54 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 54 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 54 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 54 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 54 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 54 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 54 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 54 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	05020583260313 [Unit of Use]
GS1	35020583260314 [Primary]
GS1	55020583260318 [Package]; Contains: 35020583260314; Package: [2 Units]; In Commercial Distribution

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-05-22
• Device Publish Date: 2025-05-14

Devices Manufactured by TERUMO BCT, INC.

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• 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