COBE® Spectra 70500

GUDID 35020583705006

Therapeutic Plasma Exchange Set

TERUMO BCT, INC.

Blood transfer set

• Primary Device ID: 35020583705006
• NIH Device Record Key: ea593fdd-e9d1-43fc-b844-59fd606beb19
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: COBE® Spectra
• Version Model Number: 70500
• Catalog Number: 70500
• 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
• Phone: 1 877-339-4228
• Email: FDAUDIprogram@terumobct.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	35020583705006 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• BK900002

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: 2021-06-15
• Device Publish Date: 2021-06-07

On-Brand Devices [COBE® Spectra ]

• 05020583719002: Refurbished COBE® Spectra Apheresis System
• 05020583711006: Single Needle Set
• 05020583706200: White Blood Cell Set- Functionally Closed
• 05020583703001: Single-Needle Extended Life Platelet Set With LRS® Chamber
• 05020583706309: Bone Marrow Processing Set
• 05020583706293: White Blood Cell-Functionally Closed Tubing
• 05020583706101: Auto PBSC Set
• 05020583704008: Single-Needle Extended Life Platelet Set With LRS® Chamber
• 05020583701007: Dual- Needle Extended Life Platelet Set
• 05020583700109: Single Needle Set
• 05020583706002: COBE Spectra White Blood Cell Set
• 35020583707000: Red Blood Cell Exchange Set
• 35020583705006: Therapeutic Plasma Exchange Set
• 05020583707009: Red Blood Cell Exchange Set
• 05020583705005: Therapeutic Plasma Exchange Set