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 ID05020583114012
NIH Device Record Key3fe38641-66bd-4f1a-8f4b-ef42428cc591
Commercial Distribution StatusIn Commercial Distribution
Brand NameTOMEs TERUMO OPERATIONAL MEDICAL EQUIPMENT SOFTWARE
Version Model Number11401
Catalog Number11401
Company DUNS801679200
Company NameTERUMO BCT, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone8773394228
EmailFDAUDI@terumobct.com
Phone8773394228
EmailFDAUDI@terumobct.com
Phone8773394228
EmailFDAUDI@terumobct.com
Phone8773394228
EmailFDAUDI@terumobct.com
Phone8773394228
EmailFDAUDI@terumobct.com
Phone8773394228
EmailFDAUDI@terumobct.com
Phone8773394228
EmailFDAUDI@terumobct.com
Phone8773394228
EmailFDAUDI@terumobct.com
Phone8773394228
EmailFDAUDI@terumobct.com
Phone8773394228
EmailFDAUDI@terumobct.com
Phone8773394228
EmailFDAUDI@terumobct.com
Phone8773394228
EmailFDAUDI@terumobct.com
Phone8773394228
EmailFDAUDI@terumobct.com
Phone8773394228
EmailFDAUDI@terumobct.com
Phone8773394228
EmailFDAUDI@terumobct.com

Device Identifiers

Device Issuing AgencyDevice ID
GS105020583114012 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MMHBlood Establishment Computer Software And Accessories

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-05-03
Device Publish Date2021-04-23

Devices Manufactured by TERUMO BCT, INC.

05020583114012 - TOMEs TERUMO OPERATIONAL MEDICAL EQUIPMENT SOFTWARE2021-05-03TOMEs Terumo Operational Medical Equipment Software Version 7.3
05020583114012 - TOMEs TERUMO OPERATIONAL MEDICAL EQUIPMENT SOFTWARE2021-05-03 TOMEs Terumo Operational Medical Equipment Software Version 7.3
05020583101203 - Spectra Optia® 2019-12-17 Collection Set
05020583210219 - Quantum®2019-12-17 Quantum System Cell Expansion Set and Accessories, Media Bag 4 L, Accessory Set
05020583210226 - Quantum®2019-12-17 Quantum System Cell Expansion Set and Accessories
05020583210240 - Quantum®2019-12-17 Quantum System Cell Expansion Set and Accessories, 200 Micron In-Line Filter Accessory Set
05020583700406 - Accessory Waste Bag2019-12-17 Accessory Waste Bag
05020583706002 - COBE® Spectra 2019-12-17 COBE Spectra White Blood Cell Set
05020583803008 - Trima Accel® 2019-12-17 Platelet, Plasma Set, LRS Platelet, Plasma Set

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