Spectra Optia®

GUDID 35020583122209

Exchange Sets

TERUMO BCT, INC.

Blood transfer set

• Primary Device ID: 35020583122209
• NIH Device Record Key: b9498bdb-2e74-4bde-9ce9-b226ff007728
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Spectra Optia®
• Version Model Number: 12220
• 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: true
• 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: 1 877-339-4228
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	35020583122209 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• BK150251

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: 2021-06-11
• Device Publish Date: 2021-06-03

On-Brand Devices [Spectra Optia® ]

• 05020583610002: Spectra Optia® Apheresis System
• 05020583123205: IDL Set
• 05020583113008: BMP Accessory Set
• 05020583121201: Collection Set
• 05020583103108: IDL Set
• 05020583103009: IDL Set
• 05020583101104: Collection Set
• 05020583101203: Collection Set
• 05020583102200: Exchange Set
• 35020583122209: Exchange Sets
• 35020583112200: Single-Needle Connector
• 05020583122208: Exchange Sets
• 05020583112209: Single-Needle Connector