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 | 00812747010101 | 3.x.x | SafeTrace Tx version 3.x.x | MMH | Blood Establishment Computer Software and Accessories | 2 | SafeTrace Tx | |
7 | 00812747010033 | 4.x.x | SafeTrace Tx version 4.x.x | MMH | Blood Establishment Computer Software and Accessories | 2 | SafeTrace Tx | |
8 | 30812747013851 | 08150-220-E | MCS+ (RBC), LIST NO 08150-220-E | GKT | Separator, automated, blood cell, diagnostic | 2 | MCS+ | |
9 | 30812747011673 | 0694S-00 | Plasma Bottles with Saline Adapter | KSR | CONTAINER, EMPTY, FOR COLLECTION & PROCESSING OF BLOOD & BLOOD COMPONENTS | Haemonetics® PCS®2 & NexSys PCS™ Systems | ||
10 | 20887691002872 | 732-37M | Transfer Bag 1000 ml w/Y Set | KSR | CONTAINER, EMPTY, FOR COLLECTION & PROCESSING OF BLOOD & BLOOD COMPONENTS | 2 | Haemonetics Corporation | |
11 | 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 | |
12 | 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 | |
13 | 10812747016278 | 0265F-00 | CS5/5+ FASTPACK, 125ML 20µ RES | CAC | Apparatus, Autotransfusion | 2 | HAEMONETICS CELL SAVER 5/5+ SYSTEM | |
14 | 10812747016261 | 0260F-00 | CS5/5+ FASTPACK,225ML, 20µ RES | CAC | Apparatus, Autotransfusion | 2 | HAEMONETICS CELL SAVER 5/5+ SYSTEM | |
15 | 10812747015172 | 0291A-00 | CELL SAVER 5/5+ BOWL SET (70ML) | CAC | Apparatus, Autotransfusion | HAEMONETICS CELL SAVER 5/5+ SYSTEM | ||
16 | 10812747015165 | 0263A-00 | HIGH SPEED CELL SAVER5/5+BOWL SET | CAC | Apparatus, Autotransfusion | 2 | HAEMONETICS CELL SAVER 5/5+ SYSTEM | |
17 | 10812747012492 | 09082-00 | TPE PROTOCOL/MANUAL,LN09082-00 | GKT | Separator, automated, blood cell, diagnostic | 2 | MCS+ | |
18 | 10812747012485 | 09081-00 | SDP/PLP PROT MANUL,LN 09081-00 | GKT | Separator, automated, blood cell, diagnostic | 2 | MCS+ | |
19 | 10812747011761 | 00620-CP | PLS Harness Set | GKT | Separator, automated, blood cell, diagnostic | 2 | Haemonetics® PCS®2 & NexSys PCS™ Systems | |
20 | 10812747011754 | 00620-00 | PLS Harness Set | GKT | Separator, automated, blood cell, diagnostic | 2 | Haemonetics® PCS®2 & NexSys PCS™ Systems | |
21 | 10812747011730 | 00695-00 | PLS Saline Adaptor | GKT | Separator, automated, blood cell, diagnostic | 2 | Haemonetics® PCS®2 & NexSys PCS™ Systems | |
22 | 30812747019228 | 0697S-00 | Persona™ Plasma Pooling Bottles | KSR | CONTAINER, EMPTY, FOR COLLECTION & PROCESSING OF BLOOD & BLOOD COMPONENTS | 2 | Haemonetics® NexSys PCS® System | |
23 | 30812747016616 | CSE-E-US | CELL SAVER ELITE | CAC | Apparatus, Autotransfusion | 2 | HAEMONETICS CELL SAVER ELITE SYSTEM | |
24 | 00812747010187 | 4.x.x | NexLynk DMS version 4.x.x | MMH | Blood Establishment Computer Software and Accessories | 2 | NexLynk DMS | |
25 | 00812747010149 | 3.x.x | ElDorado Donor version 3.x.x | MMH | SOFTWARE, BLOOD BANK, STAND ALONE PRODUCTS | 2 | ElDorado Donor | |
26 | 00812747010132 | 2.x.x | ElDorado Donor 2.x.x | MMH | SOFTWARE, BLOOD BANK, STAND ALONE PRODUCTS | 2 | ElDorado Donor | |
27 | 20812747016220 | 00401-00 | EXTENSION LINES | FRN | Pump, Infusion | HAEMONETICS R.I.S. SYSTEM | ||
28 | 10812747016636 | CSE-FP-225F | CS ELITE FASTPACK, 225ML, 20µ | CAC | Apparatus, Autotransfusion | 2 | HAEMONETICS CELL SAVER ELITE SYSTEM | |
29 | 10812747016582 | CSE-FP-225V | CS ELITE FASTPACK,225ML,150µ | CAC | Apparatus, Autotransfusion | 2 | HAEMONETICS CELL SAVER ELITE SYSTEM | |
30 | 10812747016575 | CSE-FP-125V | CS ELITE FASTPACK,125ML,150µ | CAC | Apparatus, Autotransfusion | 2 | HAEMONETICS CELL SAVER ELITE SYSTEM | |
31 | 10812747016568 | CSE-B-1000 | WASTE BAG, 10L | CAC | Apparatus, Autotransfusion | 2 | HAEMONETICS CELL SAVER ELITE SYSTEM | |
32 | 10812747016551 | CSE-SQ-1000 | SEQUESTRATION KIT | CAC | Apparatus, Autotransfusion | 2 | HAEMONETICS CELL SAVER ELITE SYSTEM | |
33 | 10812747016544 | CSE-P-225 | CS ELITE PROCESSING KIT (225ML) | CAC | Apparatus, Autotransfusion | 2 | HAEMONETICS CELL SAVER ELITE SYSTEM | |
34 | 10812747016537 | CSE-P-125 | CS ELITE PROCESSING KIT (125ML) | CAC | Apparatus, Autotransfusion | 2 | HAEMONETICS CELL SAVER ELITE SYSTEM | |
35 | 10812747016520 | CSE-P-70 | CS ELITE PROCESSING KIT (70ML) | CAC | Apparatus, Autotransfusion | 2 | HAEMONETICS CELL SAVER ELITE SYSTEM | |
36 | 30812747017910 | OPA-E-US | ORTHOPAT ADVANCE, LN OPA-E-US | CAC | Apparatus, Autotransfusion | 2 | HAEMONETICS ORTHOPAT ADVANCE SYSTEM | |
37 | 30812747016814 | 02005-110-EP | CS5+,110V ENG, LN02005-110-EP | CAC | Apparatus, Autotransfusion | 2 | HAEMONETICS CELL SAVER 5+ SYSTEM | |
38 | 00812747010200 | 3.x.x | Donor Doc version 3.x.x | MMH | Blood Establishment Computer Software and Accessories | 2 | Donor Doc | |
39 | 00812747010194 | 3.x.x | Symphony version 3.x.x | MMH | Blood Establishment Computer Software and Accessories | 2 | Symphony | |
40 | 00812747010064 | 1.x.x | CDCS version 1.x.x | MMH | Blood Establishment Computer Software and Accessories | 2 | CDCS (Cross Donation Check System) | |
41 | 30812747012878 | 09000-220-EW | MCS+, 220V, LN09000-220-EW-RU | GKT | Separator, automated, blood cell, diagnostic | 2 | HAEMONETICS MCS+ (LN9000) APHERESIS SYSTEM | |
42 | 30812747012854 | 09000-220-E | MCS+, 220V ENGL, LN 09000-220-E | GKT | Separator, automated, blood cell, diagnostic | 2 | HAEMONETICS MCS+ (LN9000) APHERESIS SYSTEM | |
43 | 30812747012816 | 09000-110-E | MCS+ ,110V ENGL, LN 09000-110-E | GKT | Separator, automated, blood cell, diagnostic | 2 | HAEMONETICS MCS+ (LN9000) APHERESIS SYSTEM | |
44 | 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 | |
45 | 10887691001243 | SB1E | LipiGuard SB Reinfusion Filter for Salvaged Blood | CAK | Microfilter, blood transfusion | 2 | LipiGuard SB | |
46 | 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 | |
47 | 10887691000536 | PXL8C | PXL 8 High Efficiency Leukocyte Reduction Filter for Platelets with Attached Extension Set | CAK | Microfilter, blood transfusion | 2 | PXL 8 | |
48 | 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 | |
49 | 10812747018074 | 07-016 | PLATELETMAPPING ASSAY AA | JOZ | SYSTEM, AUTOMATED PLATELET AGGREGATION | 2 | TEG HEMOSTASIS SYSTEM | |
50 | 10812747018067 | 07-015 | PLATELETMAPPING ASSAY ADP | JOZ | SYSTEM, AUTOMATED PLATELET AGGREGATION | 2 | TEG HEMOSTASIS SYSTEM |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 04260160470587 | delta System (US/CA) | 201001 | The ROTEM® delta is designed for in-vitro diagnostic use by professionals in a l The ROTEM® delta is designed for in-vitro diagnostic use by professionals in a laboratory environment. The ROTEM® delta is intended to be used to provide a qualitative and quantitative indication of the coagulation state of a blood sample. For this purpose the ROTEM® delta records the clot firmness changes in a sample of citrated whole blood as the sample clots, retracts and lyses in real time. The analyzer output consists of a qualitative graphical representation (mirrored coagulation curve - clot firmness over time) and several defined numerical parameters describing the curve quantitatively. | ROTEM® | TEM INNOVATIONS GMBH |
2 | 04260160470112 | ROTROL P | 503-25-US, 503-25 | ROTROL P is a quality control material for monitoring accuracy and precision of ROTROL P is a quality control material for monitoring accuracy and precision of tests carried out on the ROTEM® delta Thromboelastometry System. For in vitro diagnostic use only. | ROTEM® | TEM INNOVATIONS GMBH |
3 | 04260160470105 | ROTROL N | 503-24-US, 503-24 | ROTROL N is a quality control material for monitoring accuracy and precision of ROTROL N is a quality control material for monitoring accuracy and precision of tests carried out on the ROTEM® delta Thromboelastometry System. For in vitro diagnostic use only. | ROTEM® | TEM INNOVATIONS GMBH |
4 | 04260160470099 | star-tem® 20 | 503-10-US | The ROTEM® delta is designed for in-vitro diagnostic use by professionals in a l The ROTEM® delta is designed for in-vitro diagnostic use by professionals in a laboratory environ-ment. The ROTEM® delta is intended to be used to provide a qualitative and quantitative indication of the coagulation state of a blood sample. For this purpose the ROTEM® delta records the clot firmness changes in a sample of citrated whole blood as the sample clots, retracts and lyses in real time. The analyzer output consists of a qualitative graphical representation (mirrored coagulation curve – clot firmness over time) and several defined numerical parameters describing the curve quantitatively.The star-tem® reagent is intended for use as recalcification reagent in the NATEM and INTEM assay on the ROTEM® delta. The corresponding assays are described in the NATEM assay application sheet and in the Instructions for Use of the in-tem® reagent (REF 503-02-US), resp. | ROTEM® | TEM INNOVATIONS GMBH |
5 | 04260160470082 | hep-tem® | 503-09-US | The ROTEM® delta is designed for in-vitro diagnostic use by professionals in a l The ROTEM® delta is designed for in-vitro diagnostic use by professionals in a laboratory environ-ment. The ROTEM® delta is intended to be used to provide a qualitative and quantitative indication of the coagulation state of a blood sample. For this purpose the ROTEM® delta records the clot firmness changes in a sample of citrated whole blood as the sample clots, retracts and lyses in real time. The analyzer output consists of a qualitative graphical representation (mirrored coagulation curve - clot firmness over time) and several defined numerical parameters describing the curve quantitatively.The hep-tem® assay is a semi-quantitative in vitro diagnostic assay used to inactivate heparin in patients receiving unfractionated heparin on the ROTEM® delta. To monitor the coagulation process citrated whole blood specimens are used. Clotting characteristics are described by the functional parameters Clotting Time (CT), Speed of Clot Formation (CFT and alpha angle), Clot Firmness (A20/MCF) and Clot Lysis (LOT, ML, LI(x)). | ROTEM® | TEM INNOVATIONS GMBH |
6 | 04260160470044 | in-tem® | 503-02-US | The ROTEM® delta is designed for in-vitro diagnostic use by professionals in a l The ROTEM® delta is designed for in-vitro diagnostic use by professionals in a laboratory environment. The ROTEM® delta is intended to be used to provide a qualitative and quantitative indication of the coagulation state of a blood sample. For this purpose the ROTEM® delta records the clot firmness changes in a sample of citrated whole blood as the sample clots, retracts and lyses in real time. The analyzer output consists of a qualitative graphical representation (mirrored coagulation curve - clot firmness over time) and several defined numerical parameters describing the curve quantitatively.The in-tem® assay is a semi-quantitative in vitro diagnostic assay used to monitor the coagulation process via the intrinsic pathway in citrated whole blood specimens on the ROTEM® delta. Clotting characteristics are described by the functional parameters Clotting Time (CT), Speed of Clot Formation (CFT and alpha angle), Clot Firmness (A20/MCF) and Clot Lysis (LOT, ML, LI(x)). | ROTEM® | TEM INNOVATIONS GMBH |
7 | 04260160470020 | delta System | 200100-US | The ROTEM® delta is designed for in-vitro diagnostic use by professionals in a l The ROTEM® delta is designed for in-vitro diagnostic use by professionals in a laboratory environment. The ROTEM® delta is intended to be used to provide a qualitative and quantitative indication of the coagulation state of a blood sample. For this purpose the ROTEM® delta records the clot firmness changes in a sample of citrated whole blood as the sample clots, retracts and lyses in real time. The analyzer output consists of a qualitative graphical representation (mirrored coagulation curve - clot firmness over time) and several defined numerical parameters describing the curve quantitatively. | ROTEM® | TEM INNOVATIONS GMBH |
8 | 03663537043550 | 224201 | 224201 | BIOPHEN LMWH Control C4 | HYPHEN BIOMED | |
9 | 03663537043512 | 224401 | 224401 | BIOPHEN LMWH CONTROL LOW CII | HYPHEN BIOMED | |
10 | 03663537043505 | 224301 | 224301 | BIOPHEN LMWH CONTROL LOW CI | HYPHEN BIOMED | |
11 | 03663537042904 | 224101 | 224101 | BIOPHEN UFH Control C1 | HYPHEN BIOMED | |
12 | 03663537008368 | 223701 | 223701 | BIOPHEN LMWH Control Low | HYPHEN BIOMED | |
13 | 03663537008320 | 223405 | 223405 | BIOPHEN™ V-L Control Plasma | HYPHEN BIOMED | |
14 | 03663537008313 | 223301 | 223301 | BIOPHEN ABNORMAL CONTROL PLASMA | HYPHEN BIOMED | |
15 | 03663537008306 | 223201 | 223201 | BIOPHEN NORMAL CONTROL PLASMA | HYPHEN BIOMED | |
16 | 03663537008290 | 223101 | 223101 | BIOPHEN UFH Control Plasma | HYPHEN BIOMED | |
17 | 03663537008283 | 223001 | 223001 | BIOPHEN LMWH Control Plasma | HYPHEN BIOMED | |
18 | 03663537008276 | 222301 | 222301 | BIOPHEN UFH Calibrator | HYPHEN BIOMED | |
19 | 03663537008252 | 222101 | 222101 | BIOPHEN PLASMA CALIBRATOR | HYPHEN BIOMED | |
20 | 03663537008245 | 222001 | 222001 | BIOPHEN Heparin Calibrator | HYPHEN BIOMED | |
21 | 03663537007996 | 223901 | 223901 | BIOPHEN UFH CONTROL C2 | HYPHEN BIOMED | |
22 | 03663537007989 | 223801 | 223801 | BIOPHEN LMWH Control C3 | HYPHEN BIOMED | |
23 | 03607450006865 | 00686 | STA® - Quality HBPM/LMWH | DIAGNOSTICA STAGO | ||
24 | 03607450006780 | 00678 | STA® - System Control N + P | DIAGNOSTICA STAGO | ||
25 | 03607450006773 | 00677 | STA® - Coag Control (N + ABN) PLUS | DIAGNOSTICA STAGO | ||
26 | 03607450006766 | 00676 | STA® - Coag Control N + ABN | DIAGNOSTICA STAGO | ||
27 | 03607450005264 | 00526 | STA® - Liatest® Control N + P | DIAGNOSTICA STAGO | ||
28 | 03607450003819 | 00381 | STA® - Quality HNF/UFH | DIAGNOSTICA STAGO | ||
29 | 03607450002010 | 00201 | STA® - Control LA 1 + 2 | DIAGNOSTICA STAGO | ||
30 | 00885074184937 | 550-11 | CALCIUM CHLORIDE 5 ML | NA | MEDTRONIC, INC. | |
31 | 00859110005111 | 903se | 903se | Validate Heparin is intended for the quantitative determination of Calibration V Validate Heparin is intended for the quantitative determination of Calibration Verification/Linearity of the heparin anti-Xa activity on automated instruments | Validate | LGC CLINICAL DIAGNOSTICS, INC. |
32 | 00859110005104 | 903st | 903st | Validate Heparin is intended for the quantitative determination of Calibration V Validate Heparin is intended for the quantitative determination of Calibration Verification/Linearity of the heparin anti-Xa activityon automated instruments | Validate | LGC CLINICAL DIAGNOSTICS, INC. |
33 | 00859110005098 | 903il | 903il | Validate Heparin is intended for the quantitative determination of Calibration V Validate Heparin is intended for the quantitative determination of Calibration Verification/Linearity of the heparin anti-Xa activityon automated instruments | Validate | LGC CLINICAL DIAGNOSTICS, INC. |
34 | 00859110005081 | 902se | 902se | Validate D-Dimer is intended for the quantitative determination of Calibration V Validate D-Dimer is intended for the quantitative determination of Calibration Verification/Linearity of drug analytes on automated instruments. | Validate | LGC CLINICAL DIAGNOSTICS, INC. |
35 | 00859110005074 | 902st | 902st | Validate D-Dimer is intended for the quantitative determination of Calibration V Validate D-Dimer is intended for the quantitative determination of Calibration Verification/Linearity of drug analytes on automated instruments. | Validate | LGC CLINICAL DIAGNOSTICS, INC. |
36 | 00859110005067 | 902il | 902il | Validate D-Dimer is intended for the quantitative determination of Calibration V Validate D-Dimer is intended for the quantitative determination of Calibration Verification/Linearity of drug analytes on automated instruments. | Validate | LGC CLINICAL DIAGNOSTICS, INC. |
37 | 00850201006208 | 840C | 840C | ACTICLOT Protein C Resistance control plasmas | BIOMEDICA ADI INC. | |
38 | 00847661004516 | 27102X | 27102X | Liquichek D-dimer Control MiniPak (A processed human plasma assayed D-dimer control.) | Liquichek | BIO-RAD LABORATORIES, INC. |
39 | 00847661004509 | 27103 | 27103 | Liquichek D-dimer Control Level 3 (A processed human plasma assayed D-dimer control.) | Liquichek | BIO-RAD LABORATORIES, INC. |
40 | 00847661004493 | 27102 | 27102 | Liquichek D-dimer Control Level 2 (A processed human plasma assayed D-dimer control.) | Liquichek | BIO-RAD LABORATORIES, INC. |
41 | 00847661004486 | 27101 | 27101 | Liquichek D-dimer Control Level 1 (A processed human plasma assayed D-dimer control.) | Liquichek | BIO-RAD LABORATORIES, INC. |
42 | 00847661004479 | 27100 | 27100 | Liquichek D-dimer Control Level Low (A processed human plasma assayed D-dimer control.) | Liquichek | BIO-RAD LABORATORIES, INC. |
43 | 00847661001959 | 745X | 745X | Lyphochek Coagulation Control Level Trilevel MiniPak (A human plasma coagulatio Lyphochek Coagulation Control Level Trilevel MiniPak (A human plasma coagulation control.) | Lyphochek | BIO-RAD LABORATORIES, INC. |
44 | 00847661001898 | 598X | 598X | Lyphochek Hemostasis Control MiniPak (A human plasma hemostasis control.) | Lyphochek | BIO-RAD LABORATORIES, INC. |
45 | 00847661001041 | 599 | 599 | Lyphochek Hemostasis Control Level 3 (A human plasma hemostasis control.) | Lyphochek | BIO-RAD LABORATORIES, INC. |
46 | 00847661001034 | 598 | 598 | Lyphochek Hemostasis Control Level 2 (A human plasma hemostasis control.) | Lyphochek | BIO-RAD LABORATORIES, INC. |
47 | 00847661001027 | 597 | 597 | Lyphochek Hemostasis Control Level 1 (A human plasma hemostasis control.) | Lyphochek | BIO-RAD LABORATORIES, INC. |
48 | 00847661000792 | 746 | 746 | Lyphochek Coagulation Control Level 3 (A human plasma coagulation control.) | Lyphochek | BIO-RAD LABORATORIES, INC. |
49 | 00847661000785 | 745 | 745 | Lyphochek Coagulation Control Level 2 (A human plasma coagulation control.) | Lyphochek | BIO-RAD LABORATORIES, INC. |
50 | 00847661000778 | 744 | 744 | Lyphochek Coagulation Control Level 1 (A human plasma coagulation control.) | Lyphochek | BIO-RAD LABORATORIES, INC. |