Accessory Kit

GUDID 35020583700513

Accessory Sampling Kit

TERUMO BCT, INC.

Blood transfer set Blood transfer set

• Primary Device ID: 35020583700513
• NIH Device Record Key: 7f78059a-f433-4a9b-85cb-a9ee29fe3e73
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Accessory Kit
• Version Model Number: 70051
• Company DUNS: 801679200
• Company Name: TERUMO BCT, INC.
• Device Count: 30
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Protect from rain
• Storage Environment Temperature: Between 2 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Protect from rain

Device Identifiers

Device Issuing Agency	Device ID
GS1	05020583700512 [Unit of Use]
GS1	35020583700513 [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

Devices Manufactured by TERUMO BCT, INC.

• 35020583826503 - Trima Accel: 2023-06-27 Trima Accel® LRS® Platelet, Plasma, Auto RBC Set
• 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
• 05020583705005 - COBE® Spectra: 2022-09-01 Therapeutic Plasma Exchange Set