No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 00812747010057 | 4.x.x | NextGen version 4.x.x | MMH | SOFTWARE, BLOOD BANK, STAND ALONE PRODUCTS | 2 | NextGen | |
2 | 10812747018159 | 01-097 | PIPETTE KIT, 1000UL | JPA | SYSTEM, MULTIPURPOSE FOR IN VITRO COAGULATION STUDIES | 2 | TEG5000 | |
3 | 30812747013875 | 08150-110-E | MCS+ (RBC), LIST NO 08150-110-E | GKT | Separator, automated, blood cell, diagnostic | 2 | MCS+ | |
4 | 30812747018412 | 07-066 | TEG ANALYZER 5000, 230V, 60HZ, FG | JPA | SYSTEM, MULTIPURPOSE FOR IN VITRO COAGULATION STUDIES | 2 | TEG5000 HEMOSTASIS ANALYZER | |
5 | 30812747018184 | 07-022 | TEG ANALYZER, 5000, 120V, 60HZ, FG | JPA | SYSTEM, MULTIPURPOSE FOR IN VITRO COAGULATION STUDIES | 2 | TEG5000 HEMOSTASIS ANALYZER | |
6 | 00812747010033 | 4.x.x | SafeTrace Tx version 4.x.x | MMH | Blood Establishment Computer Software and Accessories | 2 | SafeTrace Tx | |
7 | 30812747013851 | 08150-220-E | MCS+ (RBC), LIST NO 08150-220-E | GKT | Separator, automated, blood cell, diagnostic | 2 | MCS+ | |
8 | 30812747011673 | 0694S-00 | Plasma Bottles with Saline Adapter | KSR | CONTAINER, EMPTY, FOR COLLECTION & PROCESSING OF BLOOD & BLOOD COMPONENTS | Haemonetics® PCS®2 & NexSys PCS™ Systems | ||
9 | 20887691002872 | 732-37M | Transfer Bag 1000 ml w/Y Set | KSR | CONTAINER, EMPTY, FOR COLLECTION & PROCESSING OF BLOOD & BLOOD COMPONENTS | 2 | Haemonetics Corporation | |
10 | 10887691304214 | BPFBLA | Leukotrap High Efficiency Leukocyte Reduction Filtration System for Red Blood Ce Leukotrap High Efficiency Leukocyte Reduction Filtration System for Red Blood Cells with BPF4 Filter | CAK | Microfilter, blood transfusion | 2 | Haemonetics Leukotrap SC RC | |
11 | 10887691000581 | RCXL1K | RCXL1 High Efficiency Leukocyte Redution Filter with Attached Straight Administr RCXL1 High Efficiency Leukocyte Redution Filter with Attached Straight Administration Set for Single Unit Blood Transfusion | CAK | Microfilter, blood transfusion | 2 | RCXL1 | |
12 | 10812747016278 | 0265F-00 | CS5/5+ FASTPACK, 125ML 20µ RES | CAC | Apparatus, Autotransfusion | 2 | HAEMONETICS CELL SAVER 5/5+ SYSTEM | |
13 | 10812747016261 | 0260F-00 | CS5/5+ FASTPACK,225ML, 20µ RES | CAC | Apparatus, Autotransfusion | 2 | HAEMONETICS CELL SAVER 5/5+ SYSTEM | |
14 | 10812747015172 | 0291A-00 | CELL SAVER 5/5+ BOWL SET (70ML) | CAC | Apparatus, Autotransfusion | HAEMONETICS CELL SAVER 5/5+ SYSTEM | ||
15 | 10812747015165 | 0263A-00 | HIGH SPEED CELL SAVER5/5+BOWL SET | CAC | Apparatus, Autotransfusion | 2 | HAEMONETICS CELL SAVER 5/5+ SYSTEM | |
16 | 10812747012492 | 09082-00 | TPE PROTOCOL/MANUAL,LN09082-00 | GKT | Separator, automated, blood cell, diagnostic | 2 | MCS+ | |
17 | 10812747012485 | 09081-00 | SDP/PLP PROT MANUL,LN 09081-00 | GKT | Separator, automated, blood cell, diagnostic | 2 | MCS+ | |
18 | 10812747011761 | 00620-CP | PLS Harness Set | GKT | Separator, automated, blood cell, diagnostic | 2 | Haemonetics® PCS®2 & NexSys PCS™ Systems | |
19 | 10812747011754 | 00620-00 | PLS Harness Set | GKT | Separator, automated, blood cell, diagnostic | 2 | Haemonetics® PCS®2 & NexSys PCS™ Systems | |
20 | 10812747011730 | 00695-00 | PLS Saline Adaptor | GKT | Separator, automated, blood cell, diagnostic | 2 | Haemonetics® PCS®2 & NexSys PCS™ Systems | |
21 | 30812747019228 | 0697S-00 | Persona™ Plasma Pooling Bottles | KSR | CONTAINER, EMPTY, FOR COLLECTION & PROCESSING OF BLOOD & BLOOD COMPONENTS | 2 | Haemonetics® NexSys PCS® System | |
22 | 30812747016616 | CSE-E-US | CELL SAVER ELITE | CAC | Apparatus, Autotransfusion | 2 | HAEMONETICS CELL SAVER ELITE SYSTEM | |
23 | 00812747010187 | 4.x.x | NexLynk DMS version 4.x.x | MMH | Blood Establishment Computer Software and Accessories | 2 | NexLynk DMS | |
24 | 00812747010149 | 3.x.x | ElDorado Donor version 3.x.x | MMH | SOFTWARE, BLOOD BANK, STAND ALONE PRODUCTS | 2 | ElDorado Donor | |
25 | 00812747010132 | 2.x.x | ElDorado Donor 2.x.x | MMH | SOFTWARE, BLOOD BANK, STAND ALONE PRODUCTS | 2 | ElDorado Donor | |
26 | 20812747016220 | 00401-00 | EXTENSION LINES | FRN | Pump, Infusion | HAEMONETICS R.I.S. SYSTEM | ||
27 | 10812747016636 | CSE-FP-225F | CS ELITE FASTPACK, 225ML, 20µ | CAC | Apparatus, Autotransfusion | 2 | HAEMONETICS CELL SAVER ELITE SYSTEM | |
28 | 10812747016582 | CSE-FP-225V | CS ELITE FASTPACK,225ML,150µ | CAC | Apparatus, Autotransfusion | 2 | HAEMONETICS CELL SAVER ELITE SYSTEM | |
29 | 10812747016575 | CSE-FP-125V | CS ELITE FASTPACK,125ML,150µ | CAC | Apparatus, Autotransfusion | 2 | HAEMONETICS CELL SAVER ELITE SYSTEM | |
30 | 10812747016568 | CSE-B-1000 | WASTE BAG, 10L | CAC | Apparatus, Autotransfusion | 2 | HAEMONETICS CELL SAVER ELITE SYSTEM | |
31 | 10812747016551 | CSE-SQ-1000 | SEQUESTRATION KIT | CAC | Apparatus, Autotransfusion | 2 | HAEMONETICS CELL SAVER ELITE SYSTEM | |
32 | 10812747016544 | CSE-P-225 | CS ELITE PROCESSING KIT (225ML) | CAC | Apparatus, Autotransfusion | 2 | HAEMONETICS CELL SAVER ELITE SYSTEM | |
33 | 10812747016537 | CSE-P-125 | CS ELITE PROCESSING KIT (125ML) | CAC | Apparatus, Autotransfusion | 2 | HAEMONETICS CELL SAVER ELITE SYSTEM | |
34 | 10812747016520 | CSE-P-70 | CS ELITE PROCESSING KIT (70ML) | CAC | Apparatus, Autotransfusion | 2 | HAEMONETICS CELL SAVER ELITE SYSTEM | |
35 | 30812747017910 | OPA-E-US | ORTHOPAT ADVANCE, LN OPA-E-US | CAC | Apparatus, Autotransfusion | 2 | HAEMONETICS ORTHOPAT ADVANCE SYSTEM | |
36 | 30812747016814 | 02005-110-EP | CS5+,110V ENG, LN02005-110-EP | CAC | Apparatus, Autotransfusion | 2 | HAEMONETICS CELL SAVER 5+ SYSTEM | |
37 | 00812747010200 | 3.x.x | Donor Doc version 3.x.x | MMH | Blood Establishment Computer Software and Accessories | 2 | Donor Doc | |
38 | 00812747010194 | 3.x.x | Symphony version 3.x.x | MMH | Blood Establishment Computer Software and Accessories | 2 | Symphony | |
39 | 00812747010064 | 1.x.x | CDCS version 1.x.x | MMH | Blood Establishment Computer Software and Accessories | 2 | CDCS (Cross Donation Check System) | |
40 | 30812747012878 | 09000-220-EW | MCS+, 220V, LN09000-220-EW-RU | GKT | Separator, automated, blood cell, diagnostic | 2 | HAEMONETICS MCS+ (LN9000) APHERESIS SYSTEM | |
41 | 30812747012854 | 09000-220-E | MCS+, 220V ENGL, LN 09000-220-E | GKT | Separator, automated, blood cell, diagnostic | 2 | HAEMONETICS MCS+ (LN9000) APHERESIS SYSTEM | |
42 | 30812747012816 | 09000-110-E | MCS+ ,110V ENGL, LN 09000-110-E | GKT | Separator, automated, blood cell, diagnostic | 2 | HAEMONETICS MCS+ (LN9000) APHERESIS SYSTEM | |
43 | 20887691308745 | 430-40 | Leukocyte Reduction Filter System for Red Blood Cells with BPF4 High Efficiency Leukocyte Reduction Filter System for Red Blood Cells with BPF4 High Efficiency Filter, 16-Segment Tubing, Storage Bag and Sample Pouch | CAK | Microfilter, blood transfusion | 2 | Leukocyte SC RC | |
44 | 10887691001243 | SB1E | LipiGuard SB Reinfusion Filter for Salvaged Blood | CAK | Microfilter, blood transfusion | 2 | LipiGuard SB | |
45 | 10887691000550 | PXL8Y | PXL 8 High Efficiency Leukocyte Reduction Filter for Platelets with Attached Y-T PXL 8 High Efficiency Leukocyte Reduction Filter for Platelets with Attached Y-Type Administration Set | CAK | Microfilter, blood transfusion | 2 | PXL 8 | |
46 | 10887691000536 | PXL8C | PXL 8 High Efficiency Leukocyte Reduction Filter for Platelets with Attached Extension Set | CAK | Microfilter, blood transfusion | 2 | PXL 8 | |
47 | 10887691000505 | PXL12K | PXL 12 High Efficiency Leukocyte Reduction Filter with Attached Straight Adminis PXL 12 High Efficiency Leukocyte Reduction Filter with Attached Straight Administration Set | CAK | Microfilter, blood transfusion | 2 | PXL 12 High Efficiency Leukocyte Reduction Filter | |
48 | 10812747018074 | 07-016 | PLATELETMAPPING ASSAY AA | JOZ | SYSTEM, AUTOMATED PLATELET AGGREGATION | 2 | TEG HEMOSTASIS SYSTEM | |
49 | 10812747018067 | 07-015 | PLATELETMAPPING ASSAY ADP | JOZ | SYSTEM, AUTOMATED PLATELET AGGREGATION | 2 | TEG HEMOSTASIS SYSTEM | |
50 | 10812747018050 | 07-014 | PLATELETMAPPING ASSAY ADP & AA | JOZ | SYSTEM, AUTOMATED PLATELET AGGREGATION | 2 | TEG HEMOSTASIS SYSTEM |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 00869202000214 | 9.0 | NA | MEDHOST OF TENNESSEE, INC. | ||
2 | 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 | |
3 | 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 | |
4 | 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. |
5 | 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. |
6 | 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. |
7 | 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. | |
8 | 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. | |
9 | 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. | |
10 | 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. |
11 | 00860475000314 | 3 | Blood Product Administration Module | EPIC SYSTEMS CORPORATION | ||
12 | 00860271000938 | VBECS 2.3.3 | VistA Blood Establishment Computer Software | VETERANS AFFAIRS, UNITED STATES DEPARTMENT OF | ||
13 | 00860271000921 | VBECS 2.3.2 | VistA Blood Establishment Computer Software | VETERANS AFFAIRS, UNITED STATES DEPARTMENT OF | ||
14 | 00860271000914 | VBECS 2.3.1 | VistA Blood Establishment Computer Software | VETERANS AFFAIRS, UNITED STATES DEPARTMENT OF | ||
15 | 00860271000907 | VBECS 2.3.0 | VistA Blood Establishment Computer Software | VETERANS AFFAIRS, UNITED STATES DEPARTMENT OF | ||
16 | 00860007397615 | 1.0 | ADIMS is a stand-alone blood establishment computer software application (BECS) ADIMS is a stand-alone blood establishment computer software application (BECS) that provides for the management of plasma and whole blood donors for an RBC immunization program as well as the record and inventory management of immunogen red blood cells. The application is used to determine donor eligibility and release of the blood or blood component for transfusion as well as tracking the preparation of immunogen components (vials) for storage and distribution. Additionally, ADIMS allows for the tracking the recipient of transfused immunogen RBCs | ADIMS | CSL PLASMA INC. | |
17 | 00860007397608 | 4.0 | LOGIC 4.0 is a web-based software application used to support daily operations o LOGIC 4.0 is a web-based software application used to support daily operations of product logistics, primarily organizing and controlling the movement of plasma units between facilities such as warehouses and fractionators. The application also communicates observations or post donation information, status and recalls between collection, warehouse and fractionation facilities. LOGIC provides interface capabilities with sub-systems. | LOGIC | CSL PLASMA INC. | |
18 | 00860007282744 | 21.x.x (US) | e-Delphyn LIS Donor 21.x.x (US) | e-Delphyn LIS Donor | GPI USA, INC. | |
19 | 00860007282737 | 5.x | Surround 5.x | Surround 5.x | GPI USA, INC. | |
20 | 00860007282720 | 3.x.x | Donor Doc 3.x.x | Donor Doc 3.x.x | GPI USA, INC. | |
21 | 00860007282713 | 3.x.x | ElDorado Donor 3.x.x | ElDorado Donor 3.x.x | GPI USA, INC. | |
22 | 00860007282706 | 11(US) | e-Delphyn Donor version 11.x.x (US) | e-Delphyn Donor | GPI USA, INC. | |
23 | 00860006793708 | 2.0.0.0 | 2.0.0.0 | Regulated Software Application (RSA), Version 2.0 is a stand-alone blood establi Regulated Software Application (RSA), Version 2.0 is a stand-alone blood establishment computer software application (BECS) that provides management controls and information services that have been designed to assist personnel in the operation of a blood center. | Regulated Software Application (RSA), Version 2.0 | ARC-ONE SOLUTIONS, LLC |
24 | 00860003545409 | 1.0.33.0 | 1.0.33.0 | 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 the blood banking process. | Regulated Software Application (RSA) | ARC-ONE SOLUTIONS, LLC |
25 | 00859474006946 | 1.0.0.17 | SoftID.Tx | SCC SOFT COMPUTER | ||
26 | 00859474006656 | 4.5.4.1 | SoftDonor | SCC SOFT COMPUTER | ||
27 | 00859474006601 | 25.6.1.0 | SoftBank | SCC SOFT COMPUTER | ||
28 | 00859474006526 | 1.0.0.16 | SoftID.Tx | SCC SOFT COMPUTER | ||
29 | 00859474006458 | 25.5.6.1 | SoftBank | SCC SOFT COMPUTER | ||
30 | 00859474006328 | 1.0.0.15 | SoftID.Tx | SCC SOFT COMPUTER | ||
31 | 00859474006311 | 25.5.3.4 | SoftBank | SCC SOFT COMPUTER | ||
32 | 00859474006304 | 25.5.6.0 | SoftBank | SCC SOFT COMPUTER | ||
33 | 00859474006281 | 25.3.1.1 | SoftBank | SCC SOFT COMPUTER | ||
34 | 00859474006243 | 25.5.5.0 | SoftBank | SCC SOFT COMPUTER | ||
35 | 00859474006236 | 25.5.4.2 | SoftBank | SCC SOFT COMPUTER | ||
36 | 00859474006229 | 1.0.0.14 | SoftID.Tx | SCC SOFT COMPUTER | ||
37 | 00859474006205 | 25.5.4.1 | SoftBank | SCC SOFT COMPUTER | ||
38 | 00859474006175 | 4.5.3.1 | SoftDonor | SCC SOFT COMPUTER | ||
39 | 00859474006151 | 1.0.0.13 | SoftID.Tx | SCC SOFT COMPUTER | ||
40 | 00859474006137 | 4.5.4.0 | SoftDonor | SCC SOFT COMPUTER | ||
41 | 00859474006113 | 25.1.3.1 | SoftBank | SCC SOFT COMPUTER | ||
42 | 00859474006090 | 25.5.3.3 | SoftBank | SCC SOFT COMPUTER | ||
43 | 00859474006083 | 1.0.0.12 | SoftID.Tx | SCC SOFT COMPUTER | ||
44 | 00859474006069 | 25.5.3.2 | SoftBank | SCC SOFT COMPUTER | ||
45 | 00859474006045 | 1.0.0.11 | SoftID.Tx | SCC SOFT COMPUTER | ||
46 | 00859474006038 | 25.5.4.0 | SoftBank | SCC SOFT COMPUTER | ||
47 | 00859474006021 | 25.5.2.1 | SoftBank | SCC SOFT COMPUTER | ||
48 | 00859474006014 | 25.3.1.0 | SoftBank | SCC SOFT COMPUTER | ||
49 | 00859474006007 | 25.1.3.0 | SoftBank | SCC SOFT COMPUTER | ||
50 | 00857222008013 | 1.0 | iWeBB electronic Laboratory Information System (iWeBB- eLIS), also referred to a iWeBB electronic Laboratory Information System (iWeBB- eLIS), also referred to as eLIS, is software for managing patient transfusion requirements, patients’ blood specimen tests, and patient laboratory results. eLIS provides the blood bank laboratory with: * Patient management * Request order management * Patient testing management * Product order and fulfillment management including an interface to the blood center’s product inventory * Computer crossmatch and manual crossmatch data management * Interfaces to laboratory instruments.Trained laboratory personnel use eLIS to record patient information, manage specimens, enter single and batch test orders, and maintain test results.In concert with inventory control modules in other blood establishment computer software, eLIS can be used to complete cross match of a patient’s requirements with products in inventory, manage blood orders and maintain product data related to patient transfusions. | electronic Laboratory Information System | CARTER BLOODCARE |