TOMEs TERUMO OPERATIONAL MEDICAL EQUIPMENT SOFTWARE 11401

GUDID 05020583114012

TOMEs Terumo Operational Medical Equipment Software Version 7.3

TERUMO BCT, INC.

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• Primary Device ID: 05020583114012
• NIH Device Record Key: 3fe38641-66bd-4f1a-8f4b-ef42428cc591
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TOMEs TERUMO OPERATIONAL MEDICAL EQUIPMENT SOFTWARE
• Version Model Number: 11401
• Catalog Number: 11401
• 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: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: true
• 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: 8773394228
• Email: FDAUDI@terumobct.com
• Phone: 8773394228
• Email: FDAUDI@terumobct.com
• Phone: 8773394228
• Email: FDAUDI@terumobct.com
• Phone: 8773394228
• Email: FDAUDI@terumobct.com
• Phone: 8773394228
• Email: FDAUDI@terumobct.com
• Phone: 8773394228
• Email: FDAUDI@terumobct.com
• Phone: 8773394228
• Email: FDAUDI@terumobct.com
• Phone: 8773394228
• Email: FDAUDI@terumobct.com
• Phone: 8773394228
• Email: FDAUDI@terumobct.com
• Phone: 8773394228
• Email: FDAUDI@terumobct.com
• Phone: 8773394228
• Email: FDAUDI@terumobct.com
• Phone: 8773394228
• Email: FDAUDI@terumobct.com
• Phone: 8773394228
• Email: FDAUDI@terumobct.com
• Phone: 8773394228
• Email: FDAUDI@terumobct.com
• Phone: 8773394228
• Email: FDAUDI@terumobct.com
• Phone: 8773394228
• Email: FDAUDI@terumobct.com
• Phone: 8773394228
• Email: FDAUDI@terumobct.com
• Phone: 8773394228
• Email: FDAUDI@terumobct.com
• Phone: 8773394228
• Email: FDAUDI@terumobct.com
• Phone: 8773394228
• Email: FDAUDI@terumobct.com
• Phone: 8773394228
• Email: FDAUDI@terumobct.com
• Phone: 8773394228
• Email: FDAUDI@terumobct.com
• Phone: 8773394228
• Email: FDAUDI@terumobct.com
• Phone: 8773394228
• Email: FDAUDI@terumobct.com
• Phone: 8773394228
• Email: FDAUDI@terumobct.com
• Phone: 8773394228
• Email: FDAUDI@terumobct.com
• Phone: 8773394228
• Email: FDAUDI@terumobct.com
• Phone: +1(877)339-4228
• Email: FDAUDI@terumobct.com
• Phone: +1(877)339-4228
• Email: FDAUDI@terumobct.com
• Phone: +1(877)339-4228
• Email: FDAUDI@terumobct.com
• Phone: +1(877)339-4228
• Email: FDAUDI@terumobct.com
• Phone: +1(877)339-4228
• Email: FDAUDI@terumobct.com
• Phone: +1(877)339-4228
• Email: FDAUDI@terumobct.com
• Phone: +1(877)339-4228
• Email: FDAUDI@terumobct.com
• Phone: +1(877)339-4228
• Email: FDAUDI@terumobct.com
• Phone: +1(877)339-4228
• Email: FDAUDI@terumobct.com
• Phone: +1(877)339-4228
• Email: FDAUDI@terumobct.com
• Phone: +1(877)339-4228
• Email: FDAUDI@terumobct.com
• Phone: +1(877)339-4228
• Email: FDAUDI@terumobct.com
• Phone: +1(877)339-4228
• Email: FDAUDI@terumobct.com
• Phone: +1(877)339-4228
• Email: FDAUDI@terumobct.com
• Phone: +1(877)339-4228
• Email: FDAUDI@terumobct.com
• Phone: +1(877)339-4228
• Email: FDAUDI@terumobct.com
• Phone: +1(877)339-4228
• Email: FDAUDI@terumobct.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	05020583114012 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• BK190333

FDA Product Code

• MMH: Blood Establishment Computer Software And Accessories

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: 2021-05-03
• Device Publish Date: 2021-04-23

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