Accessory Plasma Storage Sets

GUDID 35020583700605

Accessory Plasma Storage Sets

TERUMO BCT, INC.

Blood transfer set

• Primary Device ID: 35020583700605
• NIH Device Record Key: 5ccfcd9d-db0a-4120-8194-32b961eab3c6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Accessory Plasma Storage Sets
• Version Model Number: 70060
• Company DUNS: 801679200
• Company Name: TERUMO BCT, INC.
• Device Count: 12
• 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: 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(303)205-2510
• Email: FDAUDIprogram@terumobct.com
• Phone: +1(303)205-2510
• Email: FDAUDIprogram@terumobct.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	05020583700604 [Unit of Use]
GS1	35020583700605 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• BK870022

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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-15

On-Brand Devices [Accessory Plasma Storage Sets]

• 35020583700605: Accessory Plasma Storage Sets
• 05020583700604: Accessory Plasma Storage Sets