No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 00763000500993 | BB11N31R1 | CUSTOM PACK BB11N31R1 RESEARCH PACK | DWF | Catheter, cannula and tubing, vascular, cardiopulmonary bypass | 2 | NA | |
2 | 00763000500979 | BB11N23R | CUSTOM PACK BB11N23R 10PK XTRASUC | DWF | Catheter, cannula and tubing, vascular, cardiopulmonary bypass | 2 | NA | |
3 | 00763000500962 | BB10R11R5 | CUSTOM PACK BB10R11R5 PUMP PK | DWF | Catheter, cannula and tubing, vascular, cardiopulmonary bypass | 2 | NA | |
4 | 00763000500948 | BB5Z34R5 | CUSTOM PACK BB5Z34R5 NURSES | DWF | Catheter, cannula and tubing, vascular, cardiopulmonary bypass | 2 | NA | |
5 | 00763000500931 | BB11G46R1 | CUSTOM PACK BB11G46R1 RQST2 | DWF | Catheter, cannula and tubing, vascular, cardiopulmonary bypass | 2 | NA | |
6 | 00763000500634 | 7H97R2 | CUSTOM PACK 7H97R2 25PK FEMALE ADAPT | DWF | Catheter, cannula and tubing, vascular, cardiopulmonary bypass | 2 | NA | |
7 | 00763000500559 | HY10Z01R8 | CUSTOM PACK HY10Z01R8 SUPPORT PACK | DWF | Catheter, cannula and tubing, vascular, cardiopulmonary bypass | 2 | NA | |
8 | 00763000501105 | BB5B82R2 | CUSTOM PACK BB5B82R2 5PK SUPPLE 2 | DWF | Catheter, cannula and tubing, vascular, cardiopulmonary bypass | 2 | NA | |
9 | 00763000511555 | ONYXNG35012UX | STENT ONYXNG35012UX ONYX 3.50X12RX | NIQ | Coronary drug-eluting stent | 3 | Onyx Frontier™ | |
10 | 00763000498535 | BB11L44R2 | CUSTOM PACK BB11L44R2 OPEN HEART | DWF | Catheter, cannula and tubing, vascular, cardiopulmonary bypass | 2 | NA | |
11 | 00763000511470 | ONYXNG30015UX | STENT ONYXNG30015UX ONYX 3.00X15RX | NIQ | Coronary drug-eluting stent | 3 | Onyx Frontier™ | |
12 | 00763000511418 | ONYXNG27526UX | STENT ONYXNG27526UX ONYX 2.75X26RX | NIQ | Coronary drug-eluting stent | 3 | Onyx Frontier™ | |
13 | 00763000511326 | ONYXNG25026UX | STENT ONYXNG25026UX ONYX 2.50X26RX | NIQ | Coronary drug-eluting stent | 3 | Onyx Frontier™ | |
14 | 00763000489472 | HY7Y30R18 | CUSTOM PACK HY7Y30R18 EC AMBU | DWF | Catheter, cannula and tubing, vascular, cardiopulmonary bypass | 2 | NA | |
15 | 00763000489434 | BB7L75R3 | CUSTOM PACK BB7L75R3 10PK 3/8X 72 | DWF | Catheter, cannula and tubing, vascular, cardiopulmonary bypass | 2 | NA | |
16 | 00763000426422 | B3301533M | LEAD B3301533M SENSIGHT 1.5MM EMAN LJ53 | MHY,MRU,NHL,PJS,MBX | Stimulator, electrical, implanted, for parkinsonian tremor,implanted subcortical Stimulator, electrical, implanted, for parkinsonian tremor,implanted subcortical electrical Stimulator (motor disorders),Stimulator, electrical, implanted, for parkinsonian symptoms,Stimulator, electrical, implanted, for essential tremor,Stimulator, thalamic, epilepsy, implanted | 3 | SenSight™ | |
17 | 00763000426408 | B3300542M | LEAD B3300542M SENSIGHT 0.5MM EMAN LJ53 | MBX,NHL,MRU,PJS,MHY | Stimulator, thalamic, epilepsy, implanted,Stimulator, electrical, implanted, for Stimulator, thalamic, epilepsy, implanted,Stimulator, electrical, implanted, for parkinsonian symptoms,implanted subcortical electrical Stimulator (motor disorders),Stimulator, electrical, implanted, for essential tremor,Stimulator, electrical, implanted, for parkinsonian tremor | 3 | SenSight™ | |
18 | 00763000334178 | 11D35R | CUSTOM PACK 11D35R RETO5 | DWF | Catheter, cannula and tubing, vascular, cardiopulmonary bypass | 2 | NA | |
19 | 00763000334130 | 11D33R | CUSTOM PACK 11D33R RETO1 | DWF | Catheter, cannula and tubing, vascular, cardiopulmonary bypass | 2 | NA | |
20 | 00763000306144 | ETBF3216C166E | STENT GRAFT ETBF3216C166E ENDUR II BIF | MIH | SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | 3 | Endurant® II | |
21 | 00763000305659 | ETLW1624C93E | STENT GRAFT ETLW1624C93E ENDUR II LIMB | MIH | SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | 3 | Endurant® II | |
22 | 00763000305598 | ETLW1620C82E | STENT GRAFT ETLW1620C82E ENDUR II LIMB | MIH | SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | 3 | Endurant® II | |
23 | 00763000271220 | 7800RR36 | RING 7800RR36 SIMUFORM SR 36MM US | KRH | RING, ANNULOPLASTY | 2 | SimuForm™ | |
24 | 00763000271107 | 7700FR32 | RING 7700FR32 SIMUPLUS FLEX 32MM US | KRH | RING, ANNULOPLASTY | 2 | SimuPlus™ | |
25 | 00763000499945 | BB5U74R18 | CUSTOM PACK BB5U74R18 TUBING | DWF | Catheter, cannula and tubing, vascular, cardiopulmonary bypass | 2 | NA | |
26 | 00763000499921 | BB8S37R29 | CUSTOM PACK BB8S37R29 PUMP TBL | DWF | Catheter, cannula and tubing, vascular, cardiopulmonary bypass | 2 | NA | |
27 | 00763000511647 | ONYXNG40012UX | STENT ONYXNG40012UX ONYX 4.00X12RX | NIQ | Coronary drug-eluting stent | 3 | Onyx Frontier™ | |
28 | 00763000498870 | CB11N89R | CUSTOM PACK CB11N89R MAN/BRIDGE | DWF | Catheter, cannula and tubing, vascular, cardiopulmonary bypass | 2 | NA | |
29 | 00763000260743 | VNMC2828C90TU | STENT GRAFT VNMC2828C90TU VAL NAV CS | MIH | SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | 3 | Valiant Navion™ | |
30 | 00763000001377 | BB8B73R7 | CUSTOM PACK BB8B73R7 PK | DWE | TUBING, PUMP, CARDIOPULMONARY BYPASS | 2 | NA | |
31 | 00681490024273 | 05328 | CABLE 05328 ATAKR EGM SAFETY 8FT | LPB | Cardiac ablation percutaneous catheter | 3 | NA | |
32 | 00673978549071 | 5344 | PLUG 5344 1/4 INCH | DWE | TUBING, PUMP, CARDIOPULMONARY BYPASS | 2 | NA | |
33 | 00643169796454 | AB9U20100090 | STENT AB9U20100090 ABRE V01 | QAN | Stent, iliac vein | 3 | Abre™ | |
34 | 00643169518919 | 97740 | PROG 97740 PATIENT MRICS SCS USA ROHS | LGW | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | 3 | NA | |
35 | 00643169078024 | 500FA27 | MHV 500FA27 STD AORTIC | LWQ | HEART-VALVE, MECHANICAL | 3 | Open Pivot™ | |
36 | 00613994759221 | 680R32 | RING 680R32 PROFILE 3D 26L MEXICO | KRH | RING, ANNULOPLASTY | 2 | PROFILE 3D® | |
37 | 00613994691392 | 37642 | PRGMR 37642 PATIENT DBS W SC,PC,RC | MFR,NHL,MHY,OLM,MRU | Stimulator, brain, implanted, for behavior modification,STIMULATOR, ELECTRICAL, Stimulator, brain, implanted, for behavior modification,STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS,STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR,Deep brain stimulator for obsessive compulsive disorder (OCD),implanted subcortical electrical Stimulator (motor disorders) | 3 | NA | |
38 | 00613994334565 | 68005YN | CABLE 68005YN EGM 18L | OCL | Surgical Device, For cutting, coagulation, and/or ablation of tissue, including Surgical Device, For cutting, coagulation, and/or ablation of tissue, including cardiac tissue | 2 | NA | |
39 | 00885074469669 | 365538 | TUNNEL TOOL 365538 ACCESSORY KIT US MKT | HAO | INSTRUMENT, SURGICAL, NON-POWERED | 1 | NA | |
40 | 00885074375458 | SB7MAC30 | CATHETER SB7MAC30 SB 7F 100CM MA30 | DQY | CATHETER, PERCUTANEOUS | 2 | SHERPA NX BALANCED | |
41 | 00885074372181 | SB7EBU40D | CATHETER SB7EBU40D SB 7F 90CM EB40 | DQY | CATHETER, PERCUTANEOUS | 2 | SHERPA NX BALANCED | |
42 | 00763000665982 | BB11V67R3 | CUSTOM PACK BB11V67R3 UMC | DWF | Catheter, cannula and tubing, vascular, cardiopulmonary bypass | 2 | NA | |
43 | 00763000552985 | CB11J56R3 | CUSTOM PACK CB11J56R3 PEDI MAG | DWF | Catheter, cannula and tubing, vascular, cardiopulmonary bypass | 2 | NA | |
44 | 00763000541118 | 6A32R2 | CUSTOM PACK 6A32R2 1/4X1/4 | DWF | Catheter, cannula and tubing, vascular, cardiopulmonary bypass | 2 | NA | |
45 | 00763000400866 | 3320L | LIT 3320L DYSTONIA EMANUALS EN | MRU | implanted subcortical electrical Stimulator (motor disorders) | N/A | ||
46 | 00763000502843 | FMET-IM-SYS-S | SYSTEM SERVICED FMET-IM-SYS-S | DPW | FLOWMETER, BLOOD, CARDIOVASCULAR | 2 | FlowMet™ | |
47 | 00763000390891 | LA6ERADRST | CATHETER LA6ERADRST LA 6F 100CM ERDRS | DQY | Catheter, percutaneous | 2 | Launcher | |
48 | 00763000310332 | 37601 | INS 37601 ACTIVA PC DBS EMANUAL EN | OLM,MRU,MHY,NHL,MBX,PJS | Deep brain stimulator for obsessive compulsive disorder (OCD),implanted subcorti Deep brain stimulator for obsessive compulsive disorder (OCD),implanted subcortical electrical Stimulator (motor disorders),STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR,Stimulator, electrical, implanted, for parkinsonian symptoms,STIMULATOR, THALAMIC, EPILEPSY, IMPLANTED,Stimulator, electrical, implanted, for essential tremor | 3 | Activa® PC | |
49 | 00763000306519 | 104FS | FOOTSWITCH 104FS CRYOCONSOLE MDR | LPB | Cardiac ablation percutaneous catheter | 3 | N/A | |
50 | 00763000301330 | HC150A | HANDCRANK HC150A PLX 31L | DWA | Control, pump speed, cardiopulmonary bypass | 2 | Affinity™ |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 08426950965572 | 00000880311R | 00000880311R | ACL ELITE (Refurbished) | ACL ELITE | INSTRUMENTATION LABORATORY COMPANY |
2 | 08426950639725 | 3710-0344 | BIO-FLASH | BIO-FLASH | BIOKIT, S.A. | |
3 | 08426950585039 | 0009802204 | 0009802204 | HemosIL AcuStar Cleaning Solution | HemosIL AcuStar Cleaning Solution | INSTRUMENTATION LABORATORY COMPANY |
4 | 08426950574255 | 00097579000 | 00097579000 | HemosIL Chromogenic Optic test 160umol L | Chromogenic Optic 160 umol L | INSTRUMENTATION LABORATORY COMPANY |
5 | 08426950553502 | 00020302500 | 00020302500 | HemosIL Rinse Solution 2L (ACLFutura Advance) | HemosIL Rinse Solution (ACLFutura Advance) | INSTRUMENTATION LABORATORY COMPANY |
6 | 08426950515395 | 0020302400 | 00020302400 | HemosIL Rinse Solution 4L (ACL TOP Family) | HemosIL Rinse Solution (ACL TOP Family) | INSTRUMENTATION LABORATORY COMPANY |
7 | 08426950498001 | 0009801000 | 0009801000 | ACL AcuStar | HemosIL AcuStar | INSTRUMENTATION LABORATORY COMPANY |
8 | 08426950497042 | 0009802201 | 0009802201 | HemosIL AcuStar Triggers | HemosIL AcuStar Triggers | INSTRUMENTATION LABORATORY COMPANY |
9 | 08426950497035 | 0009802200 | 0009802200 | HemosIL AcuStar System Rinse | HemosIL AcuStar System Rinse | INSTRUMENTATION LABORATORY COMPANY |
10 | 08426950453482 | 00001000311R | 00001000311R | ACL ELITE PRO (Refurbished) | ACL ELITE PRO | INSTRUMENTATION LABORATORY COMPANY |
11 | 08426950453062 | 00020011000 | 00020011000 | HemosIL Special Test Control Level 1 | HemosIL Special Test Control Level 1 | INSTRUMENTATION LABORATORY COMPANY |
12 | 08426950453017 | 00000880311 | 00000880311 | ACL ELITE | ACL ELITE | INSTRUMENTATION LABORATORY COMPANY |
13 | 08426950452805 | 00009758080 | 00009758080 | COAGULOMETRIC OPTIC TEST, ACL FUTURA | Coagulation Optic (Advance) | INSTRUMENTATION LABORATORY COMPANY |
14 | 08426950452775 | 00009757950 | 00009757950 | HemosIL Chromogenic Optic Test Kit | Chromogenic Optic | INSTRUMENTATION LABORATORY COMPANY |
15 | 08426950452768 | 00009757980 | 00009757980 | KIT,CHROM OPTIC TEST 160MMOL L,FUTU ADVA | Chromogenic Optic (Advance) | INSTRUMENTATION LABORATORY COMPANY |
16 | 08426950452034 | 00009758050 | 00009758050 | HemosIL Coagulation Optic Test | Coagulation Optic | INSTRUMENTATION LABORATORY COMPANY |
17 | 08426950451570 | 00001000311 | 00001000311 | ACL ELITE PRO | ACL ELITE PRO | INSTRUMENTATION LABORATORY COMPANY |
18 | 08426950442189 | 00020012000 | 00020012000 | HemosIL Special Test Control Level 2 | HemosIL Special Test Control Level 2 | INSTRUMENTATION LABORATORY COMPANY |
19 | 08426950088608 | 06260040000 | 06260040000 | GEM Test ACT-LR Cartridges | GEM Test ACT-LR Cartridges | INSTRUMENTATION LABORATORY COMPANY |
20 | 08426950088585 | 06260038000 | 06260038000 | GEM Test ACT+ Cartridges | GEM Test ACT+ Cartridges | INSTRUMENTATION LABORATORY COMPANY |
21 | 08426950088561 | 06260034000 | 06260034000 | GEM Test APTT Cartridges | GEM Test APTT Cartridges | INSTRUMENTATION LABORATORY COMPANY |
22 | 08426950088554 | 06260032000 | 06260032000 | GEM Test Citrate PT Cartridges | GEM Test Citrate PT Cartridges | INSTRUMENTATION LABORATORY COMPANY |
23 | 08426950088530 | 06260030000 | 06260030000 | GEM Test PT Cartridges | GEM Test PT Cartridges | INSTRUMENTATION LABORATORY COMPANY |
24 | 08426950088523 | 06260020000 | 06260020000 | Electronic Verification Cartridge Kit | Electronic Verification Cartridge Kit | INSTRUMENTATION LABORATORY COMPANY |
25 | 08426950088516 | 06260019000 | 06260019000 | Temperature Verification Cartridges | Temperature Verification Cartridges | INSTRUMENTATION LABORATORY COMPANY |
26 | 08426950078944 | 00020002400 | 00020002400 | HemosIL Wash-R Emulsion 1000 mL | HemosIL Wash-R Emulsion | INSTRUMENTATION LABORATORY COMPANY |
27 | 08426950075882 | 00020009700 | 00020009700 | HemosIL Rinse Solution (ACL TOP Family) 4000 mL | HemosIL Rinse Solution (ACL TOP Family) | INSTRUMENTATION LABORATORY COMPANY |
28 | 08426950026549 | 0009832700 | 0009832700 | Critical Care/HemosIL Cleaning Agent (Clean B) | HemosIL Cleaning Agent (Clean B) | INSTRUMENTATION LABORATORY COMPANY |
29 | 08426950003151 | 00006800000 | 00006800000 | Rotors 100 pcs 2000 wells | Rotors 100 pcs 2000 wells | INSTRUMENTATION LABORATORY COMPANY |
30 | 08426950003083 | 00020009320 | 00020009320 | HemosIL Rinse Solution (ACL Futura Advance) 2 LIT | HemosIL Rinse Solution (ACL Futura Advance) | INSTRUMENTATION LABORATORY COMPANY |
31 | 05391521421081 | M01000 | Destiny MAX Analyzer | TCOAG IRELAND LIMITED | ||
32 | 05391521421029 | H01000P | Destiny Plus | TCOAG IRELAND LIMITED | ||
33 | 05391521421012 | N04000 | KC® 4 Delta | TCOAG IRELAND LIMITED | ||
34 | 05391521421005 | G05000 | KC® 1 Delta | TCOAG IRELAND LIMITED | ||
35 | 04987562433735 | BV981798 | CS-2500 COMPLETE | Automated Blood Coagulation Analyzer CS-2500 | SYSMEX CORPORATION | |
36 | 04987562425686 | BR142626 | Automated Blood Coagulation Analyzer CA-620 | Automated Blood Coagulation Analyzer CA-600 series CA-620 | SYSMEX CORPORATION | |
37 | 04987562425426 | BY990757 | CS-5100 COMPLETE | Automated Blood Coagulation Analyzer CS-5100 | SYSMEX CORPORATION | |
38 | 04987562409471 | 06372511 | CS-2100i COMPLETE | Automated Blood Coagulation Analyzer CS-2100i | SYSMEX CORPORATION | |
39 | G0561025161 | 102516 | 102516 | Lupus Anticoagulant Confirmation Reagent | BIO/DATA CORPORATION | |
40 | 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 |
41 | 04260160470372 | sigma | 211000 | The ROTEM sigma is an in vitro diagnostic (IVD) whole blood hemostasis system in The ROTEM sigma is an in vitro diagnostic (IVD) whole blood hemostasis system intended for use in the evaluation of coagulopathies in Point of Care (POC) or laboratory settings. It uses rotational thromboelastometry to provide semiquantitative information about the coagulation state of a blood sample. The ROTEM sigma system records the kinetic changes in a sample of 3.2% citrated whole blood during clot formation, as well as when the sample clot retracts and/or lyses.Several parameters are measured and reported for this purpose. The graphical presentation reflects the various physiological results, which describe the interaction between coagulation factors and inhibitors, fibrinogen, platelets, and the fibrinolysis system. Additionally, the effect of certain drugs influencing hemostasis, in particular some anticoagulants (e.g. heparin), can be detected. | ROTEM® | TEM INNOVATIONS GMBH |
42 | 04260160470358 | sigma ROTROL P | 555202 | The ROTEM sigma is an in vitro diagnostic (IVD) whole blood hemostasis system in The ROTEM sigma is an in vitro diagnostic (IVD) whole blood hemostasis system intended for use in the evaluation of coagulopathies in Point of Care (POC) or laboratory settings. It uses rotational thromboelastometry to provide semiquantitative information about the coagulation state of a blood sample. The ROTEM sigma system records the kinetic changes in a sample of 3.2% citrated whole blood during clot formation, as well as when the sample clot retracts and/or lyses.Several parameters are measured and reported for this purpose. The graphical presentation reflects the various physiological results, which describe the interaction between coagulation factors and inhibitors, fibrinogen, platelets, and the fibrinolysis system. Additionally, the effect of certain drugs influencing hemostasis, in particular some anticoagulants (e.g. heparin), can be detected. | ROTEM® | TEM INNOVATIONS GMBH |
43 | 04260160470341 | sigma ROTROL N | 555201 | The ROTEM sigma is an in vitro diagnostic (IVD) whole blood hemostasis system in The ROTEM sigma is an in vitro diagnostic (IVD) whole blood hemostasis system intended for use in the evaluation of coagulopathies in Point of Care (POC) or laboratory settings. It uses rotational thromboelastometry to provide semiquantitative information about the coagulation state of a blood sample. The ROTEM sigma system records the kinetic changes in a sample of 3.2% citrated whole blood during clot formation, as well as when the sample clot retracts and/or lyses.Several parameters are measured and reported for this purpose. The graphical presentation reflects the various physiological results, which describe the interaction between coagulation factors and inhibitors, fibrinogen, platelets, and the fibrinolysis system. Additionally, the effect of certain drugs influencing hemostasis, in particular some anticoagulants (e.g. heparin), can be detected. | ROTEM® | TEM INNOVATIONS GMBH |
44 | 04260160470327 | sigma complete + hep | 555502 | The ROTEM sigma is an in vitro diagnostic (IVD) whole blood hemostasis system in The ROTEM sigma is an in vitro diagnostic (IVD) whole blood hemostasis system intended for use in the evaluation of coagulopathies in Point of Care (POC) or laboratory settings. It uses rotational thromboelastometry to provide semiquantitative information about the coagulation state of a blood sample. The ROTEM sigma system records the kinetic changes in a sample of 3.2% citrated whole blood during clot formation, as well as when the sample clot retracts and/or lyses.Several parameters are measured and reported for this purpose. The graphical presentation reflects the various physiological results, which describe the interaction between coagulation factors and inhibitors, fibrinogen, platelets, and the fibrinolysis system. Additionally, the effect of certain drugs influencing hemostasis, in particular some anticoagulants (e.g. heparin), can be detected. | ROTEM® | TEM INNOVATIONS GMBH |
45 | 04260160470242 | ex-tem® | 503-05-US | The EXTEM assay is a semi-quantitative in vitro diagnostic assay used to monitor The EXTEM assay is a semi-quantitative in vitro diagnostic assay used to monitor the coagulation process via the extrinsic 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)). CFT and alpha (Speed of Clot Formation) are complementary parameters and should be used in conjunction with the main parameters Clotting Time (CT) and Clot Firmness (A20/MCF). | ROTEM® | TEM INNOVATIONS GMBH |
46 | 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 |
47 | 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 |
48 | 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 |
49 | 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 |
50 | 04260160470075 | fib-tem® | 503-06-US | The FIBTEM assay is a semi-quantitative in vitro diagnostic assay on the ROTEM® The FIBTEM assay is a semi-quantitative in vitro diagnostic assay on the ROTEM® delta Thromboelastometry System to monitor the clot firmness of citrated whole blood specimens after blocking platelet contribution to the clot firmness. fib-tem® is always used in conjunction with ex-tem®. Clotting characteristics are described by the functional parameter Clot Firmness (A20/MCF). | ROTEM® | TEM INNOVATIONS GMBH |