Other products from "TERUMO BCT, INC."
No Primary DI Version or Model Catalog Number Device Description Product Code Product Code Name Device Class Brand Name
1 05020583123205 12320 IDL Set GKT Separator, automated, blood cell, diagnostic Spectra Optia®
2 05020583103009 10300 IDL Set GKT Separator, automated, blood cell, diagnostic Spectra Optia®
3 05020583712522 71252 71252 T-Cuff® KCY Tourniquet, Pneumatic 1 T-Cuff®
4 05020583514300 51430 Bone Marrow Aspirate Concentrate (BMAC) Procedure Pack, BMAC2-240n Bone Marrow P Bone Marrow Aspirate Concentrate (BMAC) Procedure Pack, BMAC2-240n Bone Marrow Procedure Pack FMF,JQC Syringe, piston,CENTRIFUGES (MICRO, ULTRA, REFRIGERATED) FOR CLINICAL USE 1 HARVEST® BMAC®
5 05020583514294 51429 Bone Marrow Aspirate Concentrate (BMAC2) Procedure Pack, BMAC2-120n Bone Marrow Bone Marrow Aspirate Concentrate (BMAC2) Procedure Pack, BMAC2-120n Bone Marrow Procedure Pack FMF,JQC Syringe, piston,CENTRIFUGES (MICRO, ULTRA, REFRIGERATED) FOR CLINICAL USE 1 HARVEST® BMAC®
6 05020583514270 51427 Bone Marrow Aspirate Concentrate (BMAC2) Procedure Pack, BMAC2-60n Bone Marrow P Bone Marrow Aspirate Concentrate (BMAC2) Procedure Pack, BMAC2-60n Bone Marrow Procedure Pack JQC,FMF CENTRIFUGES (MICRO, ULTRA, REFRIGERATED) FOR CLINICAL USE,Syringe, piston 1 HARVEST® BMAC®
7 05020583514256 51425 Bone Marrow Aspirate Concentrate (BMAC2) Procedure Pack, BMAC2-240-01 Bone Marro Bone Marrow Aspirate Concentrate (BMAC2) Procedure Pack, BMAC2-240-01 Bone Marrow Procedure Pack JQC,FMF CENTRIFUGES (MICRO, ULTRA, REFRIGERATED) FOR CLINICAL USE,Syringe, piston 1 HARVEST® BMAC®
8 05020583514249 51424 Bone Marrow Aspirate Concentrate (BMAC2) Procedure Pack, BMAC2-180-01 Procedure Pack FMF,JQC Syringe, piston,CENTRIFUGES (MICRO, ULTRA, REFRIGERATED) FOR CLINICAL USE 1 HARVEST® BMAC®
9 05020583514232 51423 Bone Marrow Aspirate Concentrate (BMAC2) Procedure Pack, BMAC2-120-01 Procedure Pack JQC,FMF CENTRIFUGES (MICRO, ULTRA, REFRIGERATED) FOR CLINICAL USE,Syringe, piston 1 HARVEST® BMAC®
10 05020583514218 51421 Bone Marrow Aspirate Concentrate (BMAC2) Procedure Pack, BMAC2-30-02 Procedure Pack JQC,FMF CENTRIFUGES (MICRO, ULTRA, REFRIGERATED) FOR CLINICAL USE,Syringe, piston 1 HARVEST® BMAC®
11 05020583514188 51418 Bone Marrow Aspirate Concentrate (BMAC) Procedure Pack, BMAC-120-07 Procedure Pack JQC,FMF CENTRIFUGES (MICRO, ULTRA, REFRIGERATED) FOR CLINICAL USE,Syringe, piston 1 HARVEST® BMAC®
12 05020583514171 51417 Bone Marrow Aspirate Concentrate (BMAC) Procedure Pack, BMAC-60-07 Procedure Pack FMF,JQC Syringe, piston,CENTRIFUGES (MICRO, ULTRA, REFRIGERATED) FOR CLINICAL USE 1 HARVEST® BMAC®
13 05020583514164 51416 Bone Marrow Aspirate Concentrate (BMAC) Procedure PackBMAC-30-07 Procedure Pack JQC,FMF CENTRIFUGES (MICRO, ULTRA, REFRIGERATED) FOR CLINICAL USE,Syringe, piston 1 HARVEST® BMAC®
14 05020583420007 42000 elabeling.terumobct.com GKT Separator, Automated, Blood Cell, Diagnostic Rika Plasma Donation System
15 05020583212008 21200 elabeling.terumobct.com GKT Separator, Automated, Blood Cell, Diagnostic 2 Rika Plasma Separation Set
16 05020583210202 21020 Quantum System Cell Expansion Set and Accessories, Cell Inlet Bag 0.5 L, Accessory Set KJF SYSTEM, SUSPENSION, CELL CULTURE Quantum®
17 05020583122208 12220 Exchange Sets GKT Separator, Automated, Blood Cell, Diagnostic Spectra Optia®
18 05020583113008 11300 BMP Accessory Set PKG Bone marrow processing device to support hematopoietic reconstitution Spectra Optia®
19 05020583112209 11220 11220 Single-Needle Connector Spectra Optia®
20 05020583102200 10220 10220 Exchange Set LKN Separator, Automated, Blood Cell And Plasma, Therapeutic Spectra Optia®
21 05020583101203 10120 Collection Set GKT Separator, automated, blood cell, diagnostic Spectra Optia®
22 05020583101104 10110 Collection Set GKT Separator, automated, blood cell, diagnostic Spectra Optia®
23 05020583210233 21023 Quantum System Cell Expansion Set and Accessories, Waste Bag 4L, Accessory Set KJF SYSTEM, SUSPENSION, CELL CULTURE Quantum ®
24 05020583514829 51482 SmartPrep® 2 Centrifuge System JQC CENTRIFUGES (MICRO, ULTRA, REFRIGERATED) FOR CLINICAL USE 1 HARVEST® SmartPrep®
25 05020583920002 92000 Cell Expansion System KJF SYSTEM, SUSPENSION, CELL CULTURE 1 Quantum®
26 05020583620025 62002 SCD®-IIB Sterile Tubing Welder KSB SET, TRANSFER (BLOOD/PLASMA) 2 SCD®-IIB
27 05020583514997 51499 SmartPrep® 3 Multi-Cellular Processing System, Red Cell Reduction Hardware Kit JQC CENTRIFUGES (MICRO, ULTRA, REFRIGERATED) FOR CLINICAL USE 1 HARVEST®
28 05020583300040 3NCC945 Weld Integrity Test Kit KSB SET, TRANSFER (BLOOD/PLASMA) 2 TSCD®
29 05020583514980 51498 SmartPrep® 3 Multi-Cellular Processing System, 4 Place Process Disposable Holder JQC CENTRIFUGES (MICRO, ULTRA, REFRIGERATED) FOR CLINICAL USE 1 HARVEST® SmartPrep®
30 05020583514959 51495 SmartPrep® 3 Multi-Cellular Processing System, Four Place Rotor JQC CENTRIFUGES (MICRO, ULTRA, REFRIGERATED) FOR CLINICAL USE 1 HARVEST® SmartPrep®
31 05020583514942 51494 SmartPrep® 2 Centrifuge System, Two Place Rotor JQC CENTRIFUGES (MICRO, ULTRA, REFRIGERATED) FOR CLINICAL USE 1 HARVEST® SmartPrep®
32 05020583514935 51493 SmartPrep® 3 Multi-Cellular Processing System, Balance Weight/ tube Adapter TA-60 JQC CENTRIFUGES (MICRO, ULTRA, REFRIGERATED) FOR CLINICAL USE 1 HARVEST®
33 05020583514928 51492 TA-30 Balance Weight / Tube Adapter PRP30 BMAC® JQC CENTRIFUGES (MICRO, ULTRA, REFRIGERATED) FOR CLINICAL USE 1 HARVEST®
34 05020583514911 51491 SmartPrep® 3 Multi-Cellular Processing System, TA 20 JQC CENTRIFUGES (MICRO, ULTRA, REFRIGERATED) FOR CLINICAL USE 1 HARVEST® SmartPrep®
35 05020583514904 51490 SmartPrep® 3 Multi-Cellular Processing System, Balance Weight BW-60 JQC CENTRIFUGES (MICRO, ULTRA, REFRIGERATED) FOR CLINICAL USE 1 HARVEST® SmartPrep®
36 05020583514898 51489 SmartPrep® 3 Multi-Cellular Processing System, Balance Weight BW-30 JQC CENTRIFUGES (MICRO, ULTRA, REFRIGERATED) FOR CLINICAL USE 1 HARVEST®
37 05020583514881 51488 SmartPrep® 3 Multi-Cellular Processing System, Balance Weight PRP 20 BMAC® BW-20 JQC CENTRIFUGES (MICRO, ULTRA, REFRIGERATED) FOR CLINICAL USE 1 HARVEST® SmartPrep®
38 05020583514874 51487 SmartPrep® 3 Multi-Cellular Processing System, Rolling Cart 2 JQC CENTRIFUGES (MICRO, ULTRA, REFRIGERATED) FOR CLINICAL USE 1 HARVEST® SmartPrep®
39 05020583514867 51486 SmartPrep® 3 Multi-Cellular Processing System, WS-2 Work Station 2 Cart JQC CENTRIFUGES (MICRO, ULTRA, REFRIGERATED) FOR CLINICAL USE 1 HARVEST® SmartPrep®
40 05020583514836 51483 SmartPrep® 2 Centrifuge System JQC CENTRIFUGES (MICRO, ULTRA, REFRIGERATED) FOR CLINICAL USE 1 HARVEST®
41 05020583514805 51480 SmartPrep® 3 Multi-Cellular Processing System JQC CENTRIFUGES (MICRO, ULTRA, REFRIGERATED) FOR CLINICAL USE 1 HARVEST®
42 05020583514782 51478 SmartPrep® 2 Centrifuge System, Two place rotor JQC CENTRIFUGES (MICRO, ULTRA, REFRIGERATED) FOR CLINICAL USE 1 HARVEST® SmartPrep®
43 05020583514751 51475 SmartPrep® 3 Multi-Cellular Processing System JQC CENTRIFUGES (MICRO, ULTRA, REFRIGERATED) FOR CLINICAL USE 1 HARVEST® SmartPrep®
44 05020583514744 51474 SmartPRep® 2 Centrifuge System JQC CENTRIFUGES (MICRO, ULTRA, REFRIGERATED) FOR CLINICAL USE 1 HARVEST®
45 05020583514720 51472 SmartPrep® 3 Multi-Cellular Processing System JQC CENTRIFUGES (MICRO, ULTRA, REFRIGERATED) FOR CLINICAL USE 1 HARVEST®
46 05020583514706 51470 SmartPRep® 2 Centrifuge System, Two Place Rotor JQC CENTRIFUGES (MICRO, ULTRA, REFRIGERATED) FOR CLINICAL USE 1 HARVEST® SmartPrep®
47 05020583514546 51454 SmartJet® Dual Liquid Applicator Kit, LK/7 SmartJet 7 in. Liquid App. Kit FMF Syringe, piston HARVEST® SmartJet®
48 05020583514539 51453 SmartJet Dual Liquid Applicator Kit, KLK/4 dual Liquid Applicator Kit, 4 IN FMF Syringe, piston HARVEST® SmartJet®
49 05020583514522 51452 SmartJet® Dual Liquid Applicator Kit, LK/4Dual Liquid Applicator Kit, 2IN FMF Syringe, piston HARVEST® SmartJet®
50 05020583514515 51451 SmartJet® Dual Liquid Applicator Kit, SK/S SmartJet Spray Applicator Kit FMF Syringe, piston HARVEST® SmartJet®
Other products with the same Product Code "MMH"
No Primary DI Version or Model Catalog Number Device Description Brand Name Organization Name
1 B236TRM3000 3.0 Transfusion Manager is a comprehensive software application intended for use by Transfusion Manager is a comprehensive software application intended for use by trained healthcare professionals responsible for transfusion services. Transfusion Manager helps users manage the following transfusion service activities:• Positively identify transfusion recipients• Match blood products to recipients• Record recipient pertinent transfusion information• Record recipient transfusion reactions and caregiver comments Sunquest Transfusion Manager CLINISYS, INC
2 B236TRM2200 2.2.0 Sunquest Transfusion Manager is blood bank information system application software Sunquest Transfusion Manager CLINISYS, INC
3 B236TRM0 2.x Sunquest Transfusion Manager is blood bank information system application software Sunquest Transfusion Manager CLINISYS, INC
4 B236LABBB830 8.3.x Sunquest Blood Bank System Sunquest Blood Bank CLINISYS, INC
5 B236LABBB8220 8.2.2 Sunquest Blood Bank System Sunquest Blood Bank CLINISYS, INC
6 B236LABBB8210 8.2.1 Sunquest Blood Bank System Sunquest Blood Bank CLINISYS, INC
7 B236LABBB0 8.x Sunquest Blood Bank System Sunquest Blood Bank CLINISYS, INC
8 B236BB8230 8.2.3 Sunquest Blood Bank is intended for use by trained health care professionals res Sunquest Blood Bank is intended for use by trained health care professionals responsible for transfusion services. It is intended to: • Record testing results of patient specimens and blood products either manually or through instrument interfaces. • Maintain a historical record of the patient’s blood bank and transfusion related data. • Display data required to assist health care professionals when qualifying patients for electronic crossmatch. • Store records of manufactured and blood product component preparation. • Record the release of manufactured and blood products for infusion. • Maintain manufactured and blood product inventory for lookback. • Print ISBT 128 blood product labels for finished and further processed blood products and products intended for transfer. Sunquest Blood Bank CLINISYS, INC
9 B236BB8130 8.1.3 Sunquest Blood Bank is intended for use by trained health care professionals res Sunquest Blood Bank is intended for use by trained health care professionals responsible for transfusion services. It is intended to: • Record testing results of patient specimens and blood products either manually or through instrument interfaces. • Maintain a historical record of the patient’s blood bank and transfusion related data. • Display data required to assist health care professionals when qualifying patients for electronic crossmatch. • Store records of manufactured and blood product component preparation. • Record the release of manufactured and blood products for infusion. • Maintain manufactured and blood product inventory for lookback. • Print ISBT 128 blood product labels for finished and further processed blood products and products intended for transfer. Sunquest Blood Bank CLINISYS, INC
10 B236BB8010 8.0.1 Sunquest Blood Bank is intended for use by trained health care professionals res Sunquest Blood Bank is intended for use by trained health care professionals responsible for transfusion services. It is intended to: • Record testing results of patient specimens and blood products either manually or through instrument interfaces. • Maintain a historical record of the patient’s blood bank and transfusion related data. • Display data required to assist health care professionals when qualifying patients for electronic crossmatch. • Store records of manufactured and blood product component preparation. • Record the release of manufactured and blood products for infusion. • Maintain manufactured and blood product inventory for lookback. • Print ISBT 128 blood product labels for finished and further processed blood products and products intended for transfer. Sunquest Blood Bank CLINISYS, INC
11 B236BB11000 11.0 Blood Bank is intended for use by trained health care professionals responsible Blood Bank is intended for use by trained health care professionals responsible for transfusion services. It is intended to: • Record testing results of patient specimens and blood products either manually or through instrument interfaces. • Maintain a historical record of the patient’s blood bank and transfusion related data. • Display data required to assist health care professionals when qualifying patients for electronic crossmatch. • Store records of manufactured and blood product component preparation. • Record the release of manufactured and blood products for infusion. • Maintain manufactured and blood product inventory for lookback. • Print ISBT 128 blood product labels for finished and further processed blood products and products intended for transfer. Sunquest Blood Bank CLINISYS, INC
12 B236BB10110 10.1.1 Sunquest Blood Bank is intended for use by trained health care professionals res Sunquest Blood Bank is intended for use by trained health care professionals responsible for transfusion services. It is intended to: • Record testing results of patient specimens and blood products either manually or through instrument interfaces. • Maintain a historical record of the patient’s blood bank and transfusion related data. • Display data required to assist health care professionals when qualifying patients for electronic crossmatch. • Store records of manufactured and blood product component preparation. • Record the release of manufactured and blood products for infusion. • Maintain manufactured and blood product inventory for lookback. • Print ISBT 128 blood product labels for finished and further processed blood products and products intended for transfer. Sunquest Blood Bank CLINISYS, INC
13 B236BB10100 10.1 Sunquest Blood Bank is intended for use by trained health care professionals res Sunquest Blood Bank is intended for use by trained health care professionals responsible for transfusion services. It is intended to: • Record testing results of patient specimens and blood products either manually or through instrument interfaces. • Maintain a historical record of the patient’s blood bank and transfusion related data. • Display data required to assist health care professionals when qualifying patients for electronic crossmatch. • Store records of manufactured and blood product component preparation. • Record the release of manufactured and blood products for infusion. • Maintain manufactured and blood product inventory for lookback. • Print ISBT 128 blood product labels for finished and further processed blood products and products intended for transfer. Sunquest Blood Bank CLINISYS, INC
14 B236BB10010 10.0.1 Sunquest Blood Bank is intended for use by trained health care professionals res Sunquest Blood Bank is intended for use by trained health care professionals responsible for transfusion services. It is intended to: • Record testing results of patient specimens and blood products either manually or through instrument interfaces. • Maintain a historical record of the patient’s blood bank and transfusion related data. • Display data required to assist health care professionals when qualifying patients for electronic crossmatch. • Store records of manufactured and blood product component preparation. • Record the release of manufactured and blood products for infusion. • Maintain manufactured and blood product inventory for lookback. • Print ISBT 128 blood product labels for finished and further processed blood products and products intended for transfer. Sunquest Blood Bank CLINISYS, INC
15 B236BB10000 10.0 Sunquest Blood Bank is intended for use by trained health care professionals res Sunquest Blood Bank is intended for use by trained health care professionals responsible for transfusion services. It is intended to: • Record testing results of patient specimens and blood products either manually or through instrument interfaces. • Maintain a historical record of the patient’s blood bank and transfusion related data. • Display data required to assist health care professionals when qualifying patients for electronic crossmatch. • Store records of manufactured and blood product component preparation. • Record the release of manufactured and blood products for infusion. • Maintain manufactured and blood product inventory for lookback. • Print ISBT 128 blood product labels for finished and further processed blood products and products intended for transfer. Sunquest Blood Bank CLINISYS, INC
16 B180IMB028170 817 IMB02817 Instrument Manager is a stand-alone software application that provides connectiv Instrument Manager is a stand-alone software application that provides connectivity between laboratory instruments and Laboratory Information Systems, aiding the flow of laboratory information, including test orders and results, specimen information, and patient information. Instrument Manager also provides data management functions that aid in the interpretation and management of laboratory results. Instrument Manager is a software package intended to be used by trained laboratory personnel as an aid in laboratory instrument interfacing and laboratory data management. Instrument Manager DATA INNOVATIONS LLC
17 B180IMB028160 816 IMB02816 Instrument Manager is a stand-alone software application that provides connectiv Instrument Manager is a stand-alone software application that provides connectivity between laboratory instruments and Laboratory Information Systems, aiding the flow of laboratory information, including test orders and results, specimen information, and patient information. Instrument Manager also provides data management functions that aid in the interpretation and management of laboratory results. Instrument Manager is a software package intended to be used by trained laboratory personnel as an aid in laboratory instrument interfacing and laboratory data management. Instrument Manager DATA INNOVATIONS LLC
18 B180IMB028150 8150011 IMB02815 Instrument Manager is a stand-alone software application that provides connectiv Instrument Manager is a stand-alone software application that provides connectivity between laboratory instruments and Laboratory Information Systems, aiding the flow of laboratory information, including test orders and results, specimen information, and patient information. Instrument Manager also provides data management functions that aid in the interpretation and management of laboratory results. Instrument Manager is a software package intended to be used by trained laboratory personnel as an aid in laboratory instrument interfacing and laboratory data management. Instrument Manager DATA INNOVATIONS LLC
19 B180IMB028140 8141101 IMB02814 Instrument Manager is a stand-alone software application that provides connectiv Instrument Manager is a stand-alone software application that provides connectivity between laboratory instruments and Laboratory Information Systems, aiding the flow of laboratory information, including test orders and results, specimen information, and patient information. Instrument Manager also provides data management functions that aid in the interpretation and management of laboratory results. Instrument Manager is a software package intended to be used by trained laboratory personnel as an aid in laboratory instrument interfacing and laboratory data management. Instrument Manager DATA INNOVATIONS LLC
20 B105TRANSFUSION2021 2021 WellSky Transfusion 2021 is a Blood Establishment Computer Software Product. Oth WellSky Transfusion 2021 is a Blood Establishment Computer Software Product. Other than the packaging material/labeling. There is no hardware or other components included in the final product.WellSky Transfusion 2021 is intended to address all phases of transfusion services activities, and assists transfusion service personnel: • Manipulate and label products• Print ISBT 128 blood labels• Perform electronic cross match• Issue blood products under normal and emergency conditions• Receive and test patient and unit specimens• Interface to blood bank testing instruments (bi-directional)• Interface to blood storage device (bi-directional)WellSky Transfusion 2021 provides customized control processes for transfusion management of all procedures and testing on products and patients to reduce human error and enhance the ability to assure patient and product safety. WellSky Transfusion WELLSKY CORPORATION
21 B105TRANSFUSION2020 2020 WellSky Tranfusion 2020 is a Blood Establishment Computer Software Product. Othe WellSky Tranfusion 2020 is a Blood Establishment Computer Software Product. Other than the packaging material/labeling. There is no hardware or other components included in the final product.WellSky Transfusion 2020 is intended to address all phases of transfusion services activities, and assists transfusion service personnel: • Manipulate and label products• Print ISBT 128 blood labels• Perform electronic cross match• Issue blood products under normal and emergency conditions• Receive and test patient and unit specimens• Interface to blood bank testing instruments (bi-directional)• Interface to blood storage device (bi-directional)WellSky Transfusion 2020 provides customized control processes for transfusion management of all procedures and testing on products and patients to reduce human error and enhance the ability to assure patient and product safety. WellSky Transfusion WELLSKY CORPORATION
22 B105TRANSFUSION20190 2019 WellSky Tranfusion 2019 is a Blood Establishment Computer Software Product. Othe WellSky Tranfusion 2019 is a Blood Establishment Computer Software Product. Other than the packaging material/labeling. There is no hardware or other components included in the final product.WellSky Transfusion 2015 R2 is intended to address all phases of transfusion services activities, and assists transfusion service personnel: • Manipulate and label products• Print ISBT 128 blood labels• Perform electronic cross match• Issue blood products under normal and emergency conditions• Receive and test patient and unit specimens• Interface to blood bank testing instruments (bi-directional)• Interface to blood storage device (bi-directional)WellSky Transfusion 2018 provides customized control processes for transfusion management of all procedures and testing on products and patients to reduce human error and enhance the ability to assure patient and product safety. WellSky Transfusion WELLSKY CORPORATION
23 B105TRANSFUSION20180 2018 WellSky™ Transfusion 2018 is a Blood Establishment Computer Software Product. Ot WellSky™ Transfusion 2018 is a Blood Establishment Computer Software Product. Other than the packaging material/labeling, there is no hardware or other components included in the final product. WellSky™ Transfusion 2018 is intended to address all phases of transfusion services activities, and assists transfusion service personnel: • Manipulate and label products• Print ISBT 128 blood labels• Perform electronic cross match• Issue blood products under normal and emergency conditions• Receive and test patient and unit specimens• Interface to blood bank testing instruments (bi-directional)• Interface to blood storage devices (bi-directional)WellSky™ Transfusion 2018 provides customized control processes for transfusion management of all procedures and testing on products and patients to reduce human error and enhance the ability to assure patient and product safety WellSky Transfusion WELLSKY CORPORATION
24 B105TRANSFUSION0 2022 WellSky Transfusion 2022 is a Blood Establishment Computer Software Product. Oth WellSky Transfusion 2022 is a Blood Establishment Computer Software Product. Other than the packaging material/labeling.There is no hardware or other components included in the final product.WellSky Transfusion 2022 is intended to address allphases of transfusion services activities, and assists transfusion service personnel: • Manipulate and label products • Print ISBT128 blood labels • Perform electronic cross match • Issue blood products under normal and emergency conditions • Receive andtest patient and unit specimens • Interface to blood bank testing instruments (bi-directional) • Interface to blood storage device (bidirectional)WellSky Transfusion 2022 provides customized control processes for transfusion management of all procedures andtesting on products and patients to reduce human error and enhance the ability to assure patient and product safety. WellSky Transfusion WELLSKY CORPORATION
25 B105BLOODCENTERS2019 2019 Blood Centers is a comprehensive, modular, computerized system intended to be us Blood Centers is a comprehensive, modular, computerized system intended to be used by trained personnel as a tool in the management of data processes performed by staff at blood centers and high-volume testing services. User access to individual modules is controlled through defined access levels. Individual staff may be actively engaged in functions that encompass the following:• Dynamic donor eligibility status• Register, track, and audit donations and deferrals• On-line health history, physical findings, and collection process• Inter-active donor questionnaire (staff and/or donor/remote donor)• HLA/RBC search and match• Donor schedules• Component production and modification• Testing• Labeling• Imported Blood Processing• Inventory Management• Distribution• Material Check-In• Offline Data Entry (Re-entry if downtime)• Blood Centers is usable with wired/wireless networks supporting TCP/IP protocols WellSky Blood Centers WELLSKY CORPORATION
26 B105BLOODCENTERS0 2022 Blood Centers is a comprehensive, modular, computerized system intended to be us Blood Centers is a comprehensive, modular, computerized system intended to be used by trained personnel as a tool in the management of data processes performed by staff at blood centers and high-volume testing services. User access to individual modules is controlled through defined access levels. Individual staff may be actively engaged in functions that encompass the following:• Dynamic donor eligibility status• Register, track, and audit donations and deferrals• On-line health history, physical findings, and collection process• Inter-active donor questionnaire (staff and/or donor/remote donor)• HLA/RBC search and match• Donor schedules• Component production and modification• Testing• Labeling• Imported Blood Processing• Inventory Management• Distribution• Material Check-In• Offline Data Entry (Re-entry if downtime)• Blood Centers is usable with wired/wireless networks supporting TCP/IP protocols WellSky Blood Centers WELLSKY CORPORATION
27 B105BLOOD2020 2020 WellSky™ Blood – Emergency Issue 2020 R1 is a Blood Establishment Computer Softw WellSky™ Blood – Emergency Issue 2020 R1 is a Blood Establishment Computer Software (BECS) Accessory that provides the ability to perform an Emergency Issue. WellSky Blood – Emergency Issue provides customized control processes for Emergency Issue management to reduce human error and enhance the ability to assure patient product safety. Functionality is provided for patient identification, support of emergency patient safety protocols, issue blood products under emergency conditions and confirmation scan of correct transfusion slip on correct unit. WellSky™ Blood – Emergency Issue 2020 R1 can be used to emergency issue products on a mobile device and desktop workstation.WellSky™ Blood – Emergency Issue 2020 R1 is not a standalone system. WellSky™ Blood Emergency Issue 2020 depends on HCLL™ Transfusion to obtain patient data, as well as to send unit information, safety data, and regulatory inspection step data back to HCLL™ Transfusion. will communicate bi-directionally through intelligent integration messages to obtain patient information and to update and record the Emergency Issue in HCLL™ Transfusion. HCLL™ Transfusion stores this information in the Transfusion database, exactly now Transfusion processes and stored this data currently. WellSky Blood Emergency Issue does not maintain data. WellSky Blood - Emergency Issue WELLSKY CORPORATION
28 10888234001034 0064319 0064319 ImmuLINK stand-alone software is for use in a blood banking environment as an ai ImmuLINK stand-alone software is for use in a blood banking environment as an aid in interfacing and managing data between blood bank instruments, Blood Establishment Computer Software and Laboratory Information System. ImmuLINK includes the following features and/or functions: It provides the ability to create and print reports of tests and results. It supports the ability to compare current results with previous results. It supports the automatic ordering of reflex tests. It provides a tool so that test results produced by a testing platform can be remotely validated prior to delivery to an LIS. Results can also be viewed remotely and edited prior to delivery to an LIS. It provides bi-directional communication with LIS and instrument platform(s). ImmuLINK IMMUCOR, INC.
29 10885403421532 TRANSFUSION Pyxis Transfusion Verification Pyxis CAREFUSION 303, INC.
30 08055271669762 3.x.x.x GeTraP is a software application used to support daily operations of product log GeTraP is a software application used to support daily operations of product logistics primarily organizing and controlling the information about the transport of plasma units between facilities such as warehouses and fractionators. GeTraP supports trained personnel in tracking data received from suppliers, verifying each plasma units’ suitability for further manufacture. GeTraP KEDRION SPA
31 05060508820031 4.1 Software, blood bank, stand alone product Ultra Transfusion Medicine CIRDAN IMAGING LIMITED
32 05060496770059 3.1 The Liberty SRIMPORT software is an interface that is part of the SRIMPORT funct The Liberty SRIMPORT software is an interface that is part of the SRIMPORT functionality to import data through a file based transmission. Its intended use is to import results from laboratory instruments, typically chemistry and special chemistry analysers. The interface module contains no interpretation algorithms and serves as a library functions to consolidate pre-determined results from external instruments. The Liberty SRIMPORT Software's indicated use is in the Blood Bank, Donor Centre and Plasma Testing Laboratories as well as Clinical Diagnostic and Screening Laboratories. It may be applied to a group of laboratory instruments that export test results to another device. Sanguin Liberty SRIMPORT BIOMEDICAL DATA SOLUTIONS LIMITED
33 05060496770035 2.0 Sanguin Aurora 2.0 is indicated for use in Clinical Diagnostic Laboratories, Blo Sanguin Aurora 2.0 is indicated for use in Clinical Diagnostic Laboratories, Blood Bank and Blood Establishments where it captures test and result data from laboratory equipment. It can be applied to single tests or a panel of tests that are used to screen blood donation (whole blood or plasma) as a pre-requisite to transfusion. Typically these tests would include markers such as Hepatitis Markers and HIV and may include non-viral testing such as ABO and Rhesus confirmation of donors, patient typing and antibody screening. Sanguin Aurora BIOMEDICAL DATA SOLUTIONS LIMITED
34 05020583252035 25203 Vista® Information System Version 4 Vista Standard Interface and SafeTrace® BBSI Vista® Information System Version 4 Vista Standard Interface and SafeTrace® BBSI Installation Guide Vista ® TERUMO BCT, INC.
35 05020583252028 25202 Information System Version 4, Vista Standard Interface and SafeTrace®BBSI Instal Information System Version 4, Vista Standard Interface and SafeTrace®BBSI Installation Guide Vista® TERUMO BCT, INC.
36 05020583252011 25201 Vista Information System, Version 4.2 Vista ® TERUMO BCT, INC.
37 05020583114012 11401 11401 TOMEs Terumo Operational Medical Equipment Software Version 7.3 TOMEs TERUMO OPERATIONAL MEDICAL EQUIPMENT SOFTWARE TERUMO BCT, INC.
38 00869202000214 9.0 NA MEDHOST OF TENNESSEE, INC.
39 00867268000414 1.0 The LifeTec Elite system is a blood establishment computer system that receives The LifeTec Elite system is a blood establishment computer system that receives and stores data in the manufacture of blood and blood components, which blood establishments rely on for making decisions regarding the release of blood components for transfusion or further manufacturing. Specifically, laboratory testing, product manufacturing and inventory control/distribution. LifeTec Elite IT SYNERGISTICS, LLC
40 00867268000407 2.0 The DoVac Elite system is a web-based application that provides functions for ma The DoVac Elite system is a web-based application that provides functions for managing donors, donations and the collection process. The system identifies results and responses throughout the process that can be considered ‘high-risk’ to the general blood supply which notifies and allows a staff member to complete a review to determine donor suitability. The DoVac Elite application is capable of capturing all information in the collection process: registration, physical exam, computer assisted medical questionnaire, donor consent, donation identification number assignment, phlebotomy, supervisor review and audit. The system maintains a complete record of all interactions throughout including the donation process, device interfaces, auditing and donor/donation maintenance functions. DoVac Elite IT SYNERGISTICS, LLC
41 00866489000036 Version 3.0 740769 The Procleix Software is one part of the Procleix Xpress System. The Procleix Xp The Procleix Software is one part of the Procleix Xpress System. The Procleix Xpress System (software and instrument) is intended to be used to create pools of  human plasma or serum for blood screening tests for viral nucleic acids. The Procleix Xpress System automatically transfers plasma or serum from individual samples into a single master pool tube, which may be used for further testing in Procleix systems. The Procleix Xpress System also collects barcode data from all tubes, racks, and archive plates used in a given pooling run, establishing positive specimen identification and Master Pool Tube (MPT) composition. In addition, the  Procleix Xpress System can be used to dispense human plasma or serum aliquots into an archive plate. Procleix Xpress System Software GRIFOLS DIAGNOSTIC SOLUTIONS INC.
42 00866489000012 718463 718463 The Procleix Software is one part of the Procleix Xpress System. The Procleix Xp The Procleix Software is one part of the Procleix Xpress System. The Procleix Xpress System is intended to be used to create pools of  human plasma or serum for in vitro diagnostic testing, such as blood screening tests for viral nucleic acids. The Procleix Xpress System automatically transfers plasma or serum from individual samples into a single master pool tube, which may be used for further testing in Procleix systems. The Procleix Xpress System also collects barcode data from all tubes, racks, and archive plates used in a given pooling run, establishing positive specimen identification and Master Pool Tube (MPT) composition. In addition, the  Procleix Xpress System can be used to dispense human plasma or serum aliquots into an archive plate. Procleix Xpress® System GRIFOLS DIAGNOSTIC SOLUTIONS INC.
43 00866489000005 30055067 30055067 The Procleix Pipettor is one part of the Procleix Xpress System. The Procleix Xp The Procleix Pipettor is one part of the Procleix Xpress System. The Procleix Xpress System is intended to be used to create pools of  human plasma or serum for in vitro diagnostic testing, such as blood screening tests for viral nucleic acids. The Procleix Xpress System automatically transfers plasma or serum from individual samples into a single master pool tube, which may be used for further testing in Procleix systems. The Procleix Xpress System also collects barcode data from all tubes, racks, and archive plates used in a given pooling run, establishing positive specimen identification and Master Pool Tube (MPT) composition. In addition, the  Procleix Xpress System can be used to dispense human plasma or serum aliquots into an archive plate. Procleix Xpress® System GRIFOLS DIAGNOSTIC SOLUTIONS INC.
44 00863529000148 Expanse MEDITECH's Blood Bank Software is a Blood Establishment Computer System (BECS) t MEDITECH's Blood Bank Software is a Blood Establishment Computer System (BECS) that tightly integrates donor, unit and patient history information with data in the Electronic Health Record (EHR). The software's significant performance characteristics are flagging abnormal test results, reporting test and transfusion results, minimizing product waste, utilizing expert rules when recording and performing error checks. It also generates turnaround time and workload statistics, compiles statistical reports, and automatically captures charges. Expanse Blood Bank MEDICAL INFORMATION TECHNOLOGY, INC.
45 00863529000117 Client Server MEDITECH's Blood Bank application tightly integrates donor, unit, and patient hi MEDITECH's Blood Bank application tightly integrates donor, unit, and patient history information with data in the health care information system (HCIS). The application flags abnormal test results, reports test and transfusion results, minimizes product waste, utilizes expert rules when recording, and performs error checks. It also generates turnaround time and workload statistics, compiles statistical reports, and automatically captures charges. Authorized users have the ability to view blood bank results from within the network or remotely. All of these features ensure patient safety and reduce turnaround times. CLIENT SERVER Blood Bank MEDICAL INFORMATION TECHNOLOGY, INC.
46 00863529000100 Magic MEDITECH's Blood Bank application tightly integrates donor, unit, and patient hi MEDITECH's Blood Bank application tightly integrates donor, unit, and patient history information with data in the health care information system (HCIS). The application flags abnormal test results, reports test and transfusion results, minimizes product waste, utilizes expert rules when recording, and performs error checks. It also generates turnaround time and workload statistics, compiles statistical reports, and automatically captures charges. Authorized users have the ability to view blood bank results from within the network or remotely. All of these features ensure patient safety and reduce turnaround times. MAGIC Blood Bank MEDICAL INFORMATION TECHNOLOGY, INC.
47 00860664000309 1.0.19.0 1.0.19.0 The Regulated Software Application (RSA) is a system of co-dependent web based c The Regulated Software Application (RSA) is a system of co-dependent web based computer programs, used to manage and support all aspects of their blood banking processes. This system encapsulates the data access and business rules necessary for enabling blood collections, manufacturing, labeling, and distribution management efforts. Additionally, certain modules have associated administration function that creates traceability and accountability for every step of the blood banking process. The system utilizes technology standards that provide the robustness necessary for supporting web-enabled applications that interface with disparate systems. The application has been developed in a modular format. Regulated Software Application (RSA) ONEBLOOD, INC.
48 00860475000314 3 Blood Product Administration Module EPIC SYSTEMS CORPORATION
49 00860271000938 VBECS 2.3.3 VistA Blood Establishment Computer Software VETERANS AFFAIRS, UNITED STATES DEPARTMENT OF
50 00860271000921 VBECS 2.3.2 VistA Blood Establishment Computer Software VETERANS AFFAIRS, UNITED STATES DEPARTMENT OF