| No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
|---|---|---|---|---|---|---|---|---|
| 1 | 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. | MMH | Blood Establishment Computer Software And Accessories | 2 | Sunquest Blood Bank | |
| 2 | 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. | MMH | Blood Establishment Computer Software And Accessories | 2 | Sunquest Blood Bank | |
| 3 | 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. | MMH | Blood Establishment Computer Software And Accessories | 2 | Sunquest Blood Bank | |
| 4 | 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. | MMH | Blood Establishment Computer Software And Accessories | 2 | Sunquest Blood Bank | |
| 5 | 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. | MMH | Blood Establishment Computer Software And Accessories | 2 | Sunquest Blood Bank | |
| 6 | 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. | MMH | Blood Establishment Computer Software And Accessories | 2 | Sunquest Blood Bank | |
| 7 | 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. | MMH | Blood Establishment Computer Software And Accessories | 2 | Sunquest Blood Bank | |
| 8 | B236LABBB8220 | 8.2.2 | Sunquest Blood Bank System | MMH | Blood Establishment Computer Software And Accessories | 2 | Sunquest Blood Bank | |
| 9 | B236LABBB8210 | 8.2.1 | Sunquest Blood Bank System | MMH | Blood Establishment Computer Software And Accessories | 2 | Sunquest Blood Bank | |
| 10 | B236LABBB0 | 8.x | Sunquest Blood Bank System | MMH | Software, Blood Bank, Stand Alone Products | 2 | Sunquest Blood Bank | |
| 11 | B236LAB8230 | 8.2.3 | Sunquest Laboratory is intended for use by professionals working in a clinical l Sunquest Laboratory is intended for use by professionals working in a clinical laboratory.The system is marketed as an automated solution for managing laboratory processes, including: • Patient registration • Order entry and order modification • Specimen collection, verification, suitability, and distribution • Quality assurance checking • Workload recording • Billing charge capture • Standards and controls recording • Test order result inquiry and reporting • Organism susceptibility and epidemiology records • Microbiology culture direct examination and observation recording • Outreach clients, specimens, and results • Client-specific reporting capabilities • Inbound client service request tracking • Historical data | JQP | Calculator/Data Processing Module, For Clinical Use | 1 | Sunquest Laboratory | |
| 12 | B236LAB8130 | 8.1.3 | Sunquest Laboratory is intended for use by professionals working in a clinical l Sunquest Laboratory is intended for use by professionals working in a clinical laboratory.The system is marketed as an automated solution for managing laboratory processes, including: • Patient registration • Order entry and order modification • Specimen collection, verification, suitability, and distribution • Quality assurance checking • Workload recording • Billing charge capture • Standards and controls recording • Test order result inquiry and reporting • Organism susceptibility and epidemiology records • Microbiology culture direct examination and observation recording • Outreach clients, specimens, and results • Client-specific reporting capabilities • Inbound client service request tracking • Historical data | JQP | Calculator/Data Processing Module, For Clinical Use | 1 | Sunquest Laboratory | |
| 13 | B236LAB8010 | 8.0.1 | Sunquest Laboratory is intended for use by professionals working in a clinical l Sunquest Laboratory is intended for use by professionals working in a clinical laboratory.The system is marketed as an automated solution for managing laboratory processes, including: • Patient registration • Order entry and order modification • Specimen collection, verification, suitability, and distribution • Quality assurance checking • Workload recording • Billing charge capture • Standards and controls recording • Test order result inquiry and reporting • Organism susceptibility and epidemiology records • Microbiology culture direct examination and observation recording • Outreach clients, specimens, and results • Client-specific reporting capabilities • Inbound client service request tracking • Historical data | JQP | Calculator/Data Processing Module, For Clinical Use | 1 | Sunquest Laboratory | |
| 14 | B236LAB11000 | 11.0 | Sunquest Laboratory is intended for use by professionals working in a clinical l Sunquest Laboratory is intended for use by professionals working in a clinical laboratory.Sunquest Laboratory is intended for use only by professionals who have received extensivetraining in the use of the software. Sunquest Laboratory is controlled via user defined securitylevels, which allow the laboratories to manage data security and integrity. The system is marketed as an automated solution for managing laboratory processes, including:• Patient registration• Order entry and order modification• Specimen collection, verification, suitability, and distribution• Quality assurance checking• Workload recording• Billing charge capture• Standards and controls recording• Test order result inquiry and reporting• Organism susceptibility and epidemiology records• Microbiology culture direct examination and observation recording• Outreach clients, specimens, and results• Client-specific reporting capabilities• Inbound client service request tracking• Historical data | JQP | Calculator/Data Processing Module, For Clinical Use | 1 | Sunquest Laboratory | |
| 15 | B236LAB10110 | 10.1.1 | Sunquest Laboratory is intended for use by professionals working in a clinical l Sunquest Laboratory is intended for use by professionals working in a clinical laboratory.The system is marketed as an automated solution for managing laboratory processes, including: • Patient registration • Order entry and order modification • Specimen collection, verification, suitability, and distribution • Quality assurance checking • Workload recording • Billing charge capture • Standards and controls recording • Test order result inquiry and reporting • Organism susceptibility and epidemiology records • Microbiology culture direct examination and observation recording • Outreach clients, specimens, and results • Client-specific reporting capabilities • Inbound client service request tracking • Historical data | JQP | Calculator/Data Processing Module, For Clinical Use | 1 | Sunquest Laboratory | |
| 16 | B236LAB10100 | 10.1 | Sunquest Laboratory is intended for use by professionals working in a clinical l Sunquest Laboratory is intended for use by professionals working in a clinical laboratory.The system is marketed as an automated solution for managing laboratory processes, including: • Patient registration • Order entry and order modification • Specimen collection, verification, suitability, and distribution • Quality assurance checking • Workload recording • Billing charge capture • Standards and controls recording • Test order result inquiry and reporting • Organism susceptibility and epidemiology records • Microbiology culture direct examination and observation recording • Outreach clients, specimens, and results • Client-specific reporting capabilities • Inbound client service request tracking • Historical data | JQP | Calculator/Data Processing Module, For Clinical Use | 1 | Sunquest Laboratory | |
| 17 | B236LAB10010 | 10.0.1 | Sunquest Laboratory is intended for use by professionals working in a clinical l Sunquest Laboratory is intended for use by professionals working in a clinical laboratory.The system is marketed as an automated solution for managing laboratory processes, including: • Patient registration • Order entry and order modification • Specimen collection, verification, suitability, and distribution • Quality assurance checking • Workload recording • Billing charge capture • Standards and controls recording • Test order result inquiry and reporting • Organism susceptibility and epidemiology records • Microbiology culture direct examination and observation recording • Outreach clients, specimens, and results • Client-specific reporting capabilities • Inbound client service request tracking • Historical data | JQP | Calculator/Data Processing Module, For Clinical Use | 1 | Sunquest Laboratory | |
| 18 | B236LAB10000 | 10.0 | Sunquest Laboratory is intended for use by professionals working in a clinical l Sunquest Laboratory is intended for use by professionals working in a clinical laboratory.The system is marketed as an automated solution for managing laboratory processes, including: • Patient registration • Order entry and order modification • Specimen collection, verification, suitability, and distribution • Quality assurance checking • Workload recording • Billing charge capture • Standards and controls recording • Test order result inquiry and reporting • Organism susceptibility and epidemiology records • Microbiology culture direct examination and observation recording • Outreach clients, specimens, and results • Client-specific reporting capabilities • Inbound client service request tracking • Historical data | JQP | Calculator/Data Processing Module, For Clinical Use | 1 | Sunquest Laboratory | |
| 19 | 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 | MMH | Blood Establishment Computer Software And Accessories | 2 | Sunquest Transfusion Manager | |
| 20 | B236TRM2200 | 2.2.0 | Sunquest Transfusion Manager is blood bank information system application software | MMH | Blood Establishment Computer Software And Accessories | 2 | Sunquest Transfusion Manager | |
| 21 | B236TRM0 | 2.x | Sunquest Transfusion Manager is blood bank information system application software | MMH | Blood Establishment Computer Software And Accessories | 2 | Sunquest Transfusion Manager | |
| 22 | B236LABBB830 | 8.3.x | Sunquest Blood Bank System | MMH | Blood Establishment Computer Software And Accessories | 2 | Sunquest Blood Bank | |
| 23 | B236AI5300 | 5.3 | Sunquest Application Interface (AI) is to provide interfaces between client syst Sunquest Application Interface (AI) is to provide interfaces between client systems and Sunquest products to support laboratories in the management of laboratory workflow (order entry through reporting) and transfer test results and information | OUG | Medical Device Data System | 1 | Sunquest Application Interfacing | |
| 24 | B236CPP8000 | 8.0 | Sunquest CoPathPlus supports anatomic pathology laboratories in the management o Sunquest CoPathPlus supports anatomic pathology laboratories in the management of laboratory workflow (order entry through reporting), provide business analytics, and to transfer, store, and display test results and information.. | NVV | Digital Image, Storage And Communications, Non-Diagnostic, Laboratory Information System | 1 | Sunquest CoPathPlus | |
| 25 | B236CPP7100 | 7.1 | Sunquest CoPathPlus supports anatomic pathology laboratories in the management o Sunquest CoPathPlus supports anatomic pathology laboratories in the management of laboratory workflow (order entry through reporting), provide business analytics, and to transfer, store, and display test results and information.. | NVV | Digital Image, Storage And Communications, Non-Diagnostic, Laboratory Information System | 1 | Sunquest CoPathPlus | |
| 26 | B236VUE3000 | 3.0 | Sunquest VUE supports laboratories in the management of patient reports and to t Sunquest VUE supports laboratories in the management of patient reports and to transfer, store, and display test results and information. | OUG | Medical Device Data System | 1 | Sunquest VUE | |
| 27 | B236SMG6300 | 6.3 | Sunquest Mitogen™ Genetics supports laboratories in the management of patient ge Sunquest Mitogen™ Genetics supports laboratories in the management of patient genetic testing data, support reporting that includes variant information, and to transfer, store, and display test results and information. | OUG | Medical Device Data System | 1 | Sunquest Mitogen Genetics | |
| 28 | B236LIMS4100 | 4.1 | Sunquest Mitogen™ LIMS supports clinical laboratories in the management of labor Sunquest Mitogen™ LIMS supports clinical laboratories in the management of laboratory workflow (order entry through reporting) and to transfer, store, and display test results and information. | JQP | Calculator/Data Processing Module, For Clinical Use | 1 | Sunquest Mitogen LIMS | |
| 29 | B236LIMS4000 | 4.0 | Sunquest Mitogen™ LIMS supports clinical laboratories in the management of labor Sunquest Mitogen™ LIMS supports clinical laboratories in the management of laboratory workflow (order entry through reporting) and to transfer, store, and display test results and information. | JQP | Calculator/Data Processing Module, For Clinical Use | 1 | Sunquest Mitogen LIMS | |
| 30 | B236LIMS3500 | 3.5 | Sunquest Mitogen™ LIMS supports clinical laboratories in the management of labor Sunquest Mitogen™ LIMS supports clinical laboratories in the management of laboratory workflow (order entry through reporting) and to transfer, store, and display test results and information. | JQP | Calculator/Data Processing Module, For Clinical Use | 1 | Sunquest Mitogen LIMS | |
| 31 | B236LIMS3410 | 3.4.1 | Sunquest Mitogen™ LIMS supports clinical laboratories in the management of labor Sunquest Mitogen™ LIMS supports clinical laboratories in the management of laboratory workflow (order entry through reporting) and to transfer, store, and display test results and information. | JQP | Calculator/Data Processing Module, For Clinical Use | 1 | Sunquest Mitogen LIMS | |
| 32 | B236LIMS3400 | 3.4 | Sunquest Mitogen™ LIMS supports clinical laboratories in the management of labor Sunquest Mitogen™ LIMS supports clinical laboratories in the management of laboratory workflow (order entry through reporting) and to transfer, store, and display test results and information. | JQP | Calculator/Data Processing Module, For Clinical Use | 1 | Sunquest Mitogen LIMS | |
| 33 | B236LIMS3300 | 3.3 | Sunquest Mitogen™ LIMS supports clinical laboratories in the management of labor Sunquest Mitogen™ LIMS supports clinical laboratories in the management of laboratory workflow (order entry through reporting) and to transfer, store, and display test results and information. | JQP | Calculator/Data Processing Module, For Clinical Use | 1 | Sunquest Mitogen LIMS | |
| 34 | B236LIMS3200 | 3.2 | Sunquest Mitogen™ LIMS supports clinical laboratories in the management of labor Sunquest Mitogen™ LIMS supports clinical laboratories in the management of laboratory workflow (order entry through reporting) and to transfer, store, and display test results and information. | JQP | Calculator/Data Processing Module, For Clinical Use | 1 | Sunquest Mitogen LIMS | |
| 35 | B236IX3200 | 3.2 | Sunquest Instrument Interfacing provides interfaces between laboratory instrumen Sunquest Instrument Interfacing provides interfaces between laboratory instruments and Sunquest products. | OUG | Medical Device Data System | 1 | Sunquest Instrument Interfacing | |
| 36 | B236SAM7120 | 7.1.2 | Sunquest Application Manager (SAM) supports laboratories in the management of la Sunquest Application Manager (SAM) supports laboratories in the management of laboratory workflow (order entry through reporting) and to transfer test results and information. | JQP | Calculator/Data Processing Module, For Clinical Use | 1 | Sunquest Application Manager | |
| 37 | B236SAM7110 | 7.1.1 | Sunquest Application Manager (SAM) supports laboratories in the management of la Sunquest Application Manager (SAM) supports laboratories in the management of laboratory workflow (order entry through reporting) and to transfer test results and information. | JQP | Calculator/Data Processing Module, For Clinical Use | 1 | Sunquest Application Manager | |
| 38 | B236ATL20410 | 20.4.1 | Sunquest Atlas is a solution set comprised of four solutions that can be activat Sunquest Atlas is a solution set comprised of four solutions that can be activated individually or together to meet the needs of our clients. All four solutions are supported with the same core platform.• Sunquest Physician Portal• Sunquest Advanced EMR Connectivity• Sunquest Patient Service Center (PSC) Portal• Sunquest Multi-Lab NetworkingThese solutions together represent a robust software solution set that enables diagnostic testing facilities to successfully support electronic ordering and/or result reporting with physician offices, nursing homes, patient service centers, reference labs, and other healthcare facilities. | JQP | Calculator/Data Processing Module, For Clinical Use | 1 | Sunquest Atlas | |
| 39 | B236ATL202210 | 2022.1 | Sunquest Atlas is a solution set comprised of four solutions that can be activat Sunquest Atlas is a solution set comprised of four solutions that can be activated individually or together to meet the needs of our clients. All four solutions are supported with the same core platform.• Sunquest Physician Portal• Sunquest Advanced EMR Connectivity• Sunquest Patient Service Center (PSC) Portal• Sunquest Multi-Lab Networking | JQP | Calculator/Data Processing Module, For Clinical Use | 1 | Sunquest Atlas | |
| 40 | B236PWP13000 | 13.0 | The intended use of Sunquest PowerPath is to support anatomic pathology laborato The intended use of Sunquest PowerPath is to support anatomic pathology laboratories in the management of laboratory workflow (order entry through reporting), provide business analytics, and to transfer, store, and display test results and information. | NVV | Digital Image, Storage And Communications, Non-Diagnostic, Laboratory Information System | 1 | Sunquest PowerPath | |
| 41 | B236PWP12000 | 12.0 | Sunquest PowerPath supports anatomic pathology laboratories in the management of Sunquest PowerPath supports anatomic pathology laboratories in the management of laboratory workflow (order entry through reporting), provide business analytics, and to transfer, store, and display test results and information. | NVV | Digital Image, Storage And Communications, Non-Diagnostic, Laboratory Information System | 1 | Sunquest PowerPath |
| 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 |