No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 40841716102200 | 016613 | CVi1 Injector p/n 801091-002Contents: CVi Injector Head (Siemens), Bed Mount, & CVi1 Injector p/n 801091-002Contents: CVi Injector Head (Siemens), Bed Mount, & Power Supply | DXT | Injector And Syringe, Angiographic | 2 | ACIST CVi®1 Contrast Delivery System | |
2 | 30841716102036 | 015636 | CVi Medex Spacelabs cable, p/n 300501-001 | DXT | Injector And Syringe, Angiographic | 2 | CVi® Cable | |
3 | 30841716101138 | 017398 | CVi interface cable, p/n 700709-006 | DXT | Injector And Syringe, Angiographic | 2 | CVi® Cable | |
4 | 30841716101121 | 017399 | CVi interface cable, p/n 700709-005 | DXT | Injector And Syringe, Angiographic | 2 | CVi® Cable | |
5 | 30841716101114 | 017397 | CVi cable, p/n 700658-004 | DXT | Injector And Syringe, Angiographic | 2 | CVi® Cable | |
6 | 30841716101107 | 017396 | CVi cable, p/n 700658-003 | DXT | Injector And Syringe, Angiographic | 2 | CVi® Cable | |
7 | 30841716101091 | 016213 | CVi cable, p/n 700658-002 | DXT | Injector And Syringe, Angiographic | 2 | CVi® Cable | |
8 | 30841716101084 | 0146CG | CVi cable, p/n 700658-001 | DXT | Injector And Syringe, Angiographic | 2 | CVi® Cable | |
9 | 30841716101077 | 017394 | CVi interface cable, p/n 700402-003 | DXT | Injector And Syringe, Angiographic | 2 | CVi® Cable | |
10 | 30841716101060 | 0146DA | CVi interface cable, p/n 700402-002 | DXT | Injector And Syringe, Angiographic | 2 | CVi® Cable | |
11 | 30841716101053 | 017393 | CVi interface cable, p/n 700385-004 | DXT | Injector And Syringe, Angiographic | 2 | CVi® Cable | |
12 | 30841716101046 | 0146CI | CVi interface cable, p/n 700318-003 | DXT | Injector And Syringe, Angiographic | 2 | CVi® Cable | |
13 | 30841716100995 | 015433 | CVi controller interface cable, p/n 301188-001 | DXT | Injector And Syringe, Angiographic | 2 | CVi® Cable | |
14 | 30841716100988 | 015757 | CVi controller interface cable, p/n 301179-001 | DXT | Injector And Syringe, Angiographic | 2 | CVi® Cable | |
15 | 30841716100971 | 015429 | CVi hemodynamic cable, p/n 300874-001 | DXT | Injector And Syringe, Angiographic | 2 | CVi® Cable | |
16 | 30841716100964 | 015646 | CVi single channel transducer cable, p/n 300814-001 | DXT | Injector And Syringe, Angiographic | 2 | CVi® Cable | |
17 | 30841716100957 | 015417 | CVi ground cord, p/n 300542-001 | DXT | Injector And Syringe, Angiographic | 2 | CVi® Cable | |
18 | 30841716100940 | 015645 | CVi cable, p/n 300522-001 | DXT | Injector And Syringe, Angiographic | 2 | CVi® Cable | |
19 | 30841716100933 | 015644 | CVi hemodynamic cable, p/n 300521-001 | DXT | Injector And Syringe, Angiographic | 2 | CVi® Cable | |
20 | 30841716100926 | 015643 | CVi cable, p/n 300520-001 | DXT | Injector And Syringe, Angiographic | 2 | CVi® Cable | |
21 | 30841716100919 | 015641 | CVi cable, p/n 300506-001 | DXT | Injector And Syringe, Angiographic | 2 | CVi® Cable | |
22 | 30841716100902 | 015640 | CVi cable, p/n 300505-001 | DXT | Injector And Syringe, Angiographic | 2 | CVi® Cable | |
23 | 30841716100896 | 015639 | CVi cable, p/n 300504-001 | DXT | Injector And Syringe, Angiographic | 2 | CVi® Cable | |
24 | 30841716100889 | 015634 | CVi cable, p/n 300498-001 | DXT | Injector And Syringe, Angiographic | 2 | CVi® Cable | |
25 | 30841716100872 | 015632 | CVi cable, p/n 300496-001 | DXT | Injector And Syringe, Angiographic | 2 | CVi® Cable | |
26 | 30841716100865 | 015631 | CVi cable, p/n 300495-001 | DXT | Injector And Syringe, Angiographic | 2 | CVi® Cable | |
27 | 30841716100858 | 015629 | CVi single channel transducer cable, p/n 300459-001 | DXT | Injector And Syringe, Angiographic | 2 | CVi® Cable | |
28 | 30841716100841 | 015628 | CVi single channel transducer cable, p/n 300457-001 | DXT | Injector And Syringe, Angiographic | 2 | CVi® Cable | |
29 | 30841716100834 | 0146AO | CVi single channel transducer cable, p/n 300456-001 | DXT | Injector And Syringe, Angiographic | 2 | CVi® Cable | |
30 | 30841716100827 | 014610 | CVi single channel transducer cable, p/n 300455-001 | DXT | Injector And Syringe, Angiographic | 2 | CVi® Cable | |
31 | 30841716100810 | 0146AM | CVi single channel transducer cable, p/n 300453-001 | DXT | Injector And Syringe, Angiographic | 2 | CVi® Cable | |
32 | 30841716100186 | 0146CC | CVi Adjustable Arm, p/n 800625-001 | DXT | Injector And Syringe, Angiographic | 2 | ACIST CVi® Adjustable Arm | |
33 | 10841716101202 | 017991 | HDi Cart, p/n 205046-005 | OBJ | Catheter, Ultrasound, Intravascular | 2 | ACIST HDi® Cart | |
34 | 10841716102643 | 017991 | HDi Cart, p/n 205046-006 | IYO | System, Imaging, Pulsed Echo, Ultrasonic | 2 | ACIST HDi® Cart | |
35 | 10841716101899 | 016227 | ACIST CVi® Contrast Delivery System Control Panel, p/n 701557-002 | DXT | Injector And Syringe, Angiographic | 2 | ACIST CVi® Contrast Delivery System Control Panel | |
36 | 10841716101738 | 014666 | RXi System Console, p/n 701640-001 | OBI | Catheter, Pressure Monitoring, Cardiac | 2 | ACIST RXi® System | |
37 | 10841716101257 | 014666 | RXi System Console, p/n 701309-008 | OBI | Catheter, Pressure Monitoring, Cardiac | 2 | ACIST RXi® System | |
38 | 10841716100267 | 014621 | Model B2000 p/n 700303-011Kit Contents: manifold with saline and contrast ports, Model B2000 p/n 700303-011Kit Contents: manifold with saline and contrast ports, saline tubing with spike and hand syringe | DXT | Injector And Syringe, Angiographic | 2 | B2000 Automated Manifold Kit | |
39 | 40841716102101 | 016375 | ACI Hardware, HDi System p/n 801085-001Contents: ACI Hardware | OBJ | Catheter, Ultrasound, Intravascular | 2 | ACIST HDi® HD IVUS System | |
40 | 40841716102057 | 016323 | HDi System Overpack, with ACIST Connect, JAPAN p/n 801081-001Contents: System Co HDi System Overpack, with ACIST Connect, JAPAN p/n 801081-001Contents: System Console, Linear Translation System (LTS), Patient Interface Module (PIM), Power Supply, ACI Hardware | OBJ | Catheter, Ultrasound, Intravascular | 2 | ACIST HDi® HD IVUS System | |
41 | 40841716101982 | 017986 | HDi System Overpack p/n 801029-002Contents: System Console, Linear Translation S HDi System Overpack p/n 801029-002Contents: System Console, Linear Translation System (LTS), Patient Interface Module (PIM), Power Supply | OBJ | Catheter, Ultrasound, Intravascular | 2 | ACIST HDi® HD IVUS System | |
42 | 40841716102552 | 017986 | HDi System Overpack p/n 800994-005Contents: System Console, Linear Translation S HDi System Overpack p/n 800994-005Contents: System Console, Linear Translation System (LTS), Patient Interface Module (PIM), Power Supply | IYO | System, Imaging, Pulsed Echo, Ultrasonic | 2 | ACIST HDi® HD IVUS System | |
43 | 40841716101869 | 017986 | HDi System Overpack p/n 800994-004Contents: System Console, Linear Translation S HDi System Overpack p/n 800994-004Contents: System Console, Linear Translation System (LTS), Patient Interface Module (PIM), Power Supply | OBJ | Catheter, Ultrasound, Intravascular | 2 | ACIST HDi® HD IVUS System | |
44 | 40841716101746 | 014666 | RXi System Overpack, p/n 800981-004Contents: Console, Power Supply, Bed Mount, U RXi System Overpack, p/n 800981-004Contents: Console, Power Supply, Bed Mount, USB Drive, and Accessory Box (Cables) | OBI | Catheter, Pressure Monitoring, Cardiac | 2 | ACIST RXi® System and Accessories | |
45 | 40841716100763 | 018083 | RXi System Overpack, p/n 801005-002Contents: Refurbished Console, Power Supply, RXi System Overpack, p/n 801005-002Contents: Refurbished Console, Power Supply, Bed Mount, USB Drive | OBI | Catheter, Pressure Monitoring, Cardiac | 2 | ACIST RXi® System and Accessories | |
46 | 40841716100749 | 017986 | HDi System Overpack p/n 801029-001Contents: System Console, Linear Translation S HDi System Overpack p/n 801029-001Contents: System Console, Linear Translation System (LTS), Patient Interface Module (PIM), Power Supply | OBJ | Catheter, Ultrasound, Intravascular | 2 | ACIST HDi® HD IVUS System | |
47 | 40841716100732 | 014666 | RXi System Overpack, p/n 801027-001Contents: Console, Power Supply, Bed Mount, U RXi System Overpack, p/n 801027-001Contents: Console, Power Supply, Bed Mount, USB Drive, and Accessory Box (Cables) | OBI | Catheter, Pressure Monitoring, Cardiac | 2 | ACIST RXi® System and Accessories | |
48 | 40841716100671 | 014666 | RXi System Overpack, p/n 800981-003Contents: Console, Power Supply, Bed Mount, U RXi System Overpack, p/n 800981-003Contents: Console, Power Supply, Bed Mount, USB Drive, and Accessory Box (Cables) | OBI | Catheter, Pressure Monitoring, Cardiac | 2 | ACIST RXi® System and Accessories | |
49 | 40841716100664 | 014666 | RXi System Overpack, p/n 800981-002Contents: Console, Power Supply, Bed Mount, U RXi System Overpack, p/n 800981-002Contents: Console, Power Supply, Bed Mount, USB Drive, and Accessory Box (Cables) | OBI | Catheter, Pressure Monitoring, Cardiac | 2 | ACIST RXi® System and Accessories | |
50 | 40841716100251 | 017986 | HDi System Overpack p/n 800994-003Contents: System Console, Linear Translation S HDi System Overpack p/n 800994-003Contents: System Console, Linear Translation System (LTS), Patient Interface Module (PIM), Power Supply | OBJ | Catheter, Ultrasound, Intravascular | 2 | ACIST HDi® HD IVUS System |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 05415067002082 | Xtra | D087031 | ViewFlex™ | IRVINE BIOMEDICAL, INC. | |
2 | 04056869275079 | 11508800 | AcuNav Volume ICE Catheter | SIEMENS MEDICAL SOLUTIONS USA, INC. | ||
3 | 04056869004266 | 10855958 | AcuNav Volume Ultrasound Catheter | SIEMENS MEDICAL SOLUTIONS USA, INC. | ||
4 | 04056869002804 | 10433816 | ACUSON SC2000 Diagnostic Ultrasound System | SIEMENS MEDICAL SOLUTIONS USA, INC. | ||
5 | 04056869001050 | 10043260 | AcuNav V 10F Ultrasound Catheter | SIEMENS MEDICAL SOLUTIONS USA, INC. | ||
6 | 04056869001043 | 10135910 | AcuNav G 8F Ultrasound Catheter | SIEMENS MEDICAL SOLUTIONS USA, INC. | ||
7 | 04056869001036 | 10043342 | AcuNav G 10F Ultrasound Catheter | SIEMENS MEDICAL SOLUTIONS USA, INC. | ||
8 | 04056869001029 | 10135936 | AcuNav 8F Ultrasound Catheter | SIEMENS MEDICAL SOLUTIONS USA, INC. | ||
9 | 04056869001012 | 08255790 | AcuNav 10F Ultrasound Catheter | SIEMENS MEDICAL SOLUTIONS USA, INC. | ||
10 | 00884838114470 | 795186 | Software Version 6.X | Affiniti 70C Diagnostic Ultrasound System | PHILIPS ULTRASOUND, INC. | |
11 | 00884838114463 | 795185 | Software Version 6.X | Affiniti 70W Diagnostic Ultrasound System | PHILIPS ULTRASOUND, INC. | |
12 | 00884838114456 | 795187 | Software Version 6.X | Affiniti 70 Diagnostic Ultrasound System | PHILIPS ULTRASOUND, INC. | |
13 | 00884838113961 | 795125 | Software Version 9.x | EPIQ Elite Ultrasound Circular Edition | PHILIPS ULTRASOUND, INC. | |
14 | 00884838113923 | 795122 | Software Version 9.x | EPIQ CVx Ultrasound Circular Edition | PHILIPS ULTRASOUND, INC. | |
15 | 00884838113916 | 795122 | Software version 7.x | EPIQ CVx Ultrasound Circular Edition | PHILIPS ULTRASOUND, INC. | |
16 | 00884838113909 | 795121 | Software version 9.X | Affiniti 30 Ultrasound Circular Edition | PHILIPS ULTRASOUND, INC. | |
17 | 00884838113893 | 795121 | Software version 7.x | Affiniti 30 Ultrasound Circular Edition | PHILIPS ULTRASOUND, INC. | |
18 | 00884838113886 | 795120 | Software Version 9.X | EPIQ 5 Ultrasound Circular Edition | PHILIPS ULTRASOUND, INC. | |
19 | 00884838113862 | 795119 | Software version 9.X | Affiniti 70 Ultrasound Circular Edition | PHILIPS ULTRASOUND, INC. | |
20 | 00884838113855 | 795119 | Software version 7.x | Affiniti 70 Ultrasound Circular Edition | PHILIPS ULTRASOUND, INC. | |
21 | 00884838113848 | 795118 | 9.X | Affiniti 50 Ultrasound Circular Edition | PHILIPS ULTRASOUND, INC. | |
22 | 00884838113831 | 795118 | Software Version 7.X | Affiniti 50 Ultrasound Circular Edition | PHILIPS ULTRASOUND, INC. | |
23 | 00884838113824 | 795117 | Software Version 9.X | EPIQ 7 Ultrasound Circular Edition | PHILIPS ULTRASOUND, INC. | |
24 | 00884838111004 | 795258 | Software version 6.X | EPIQ Elite W Diagnostic Ultrasound System | PHILIPS ULTRASOUND, INC. | |
25 | 00884838107540 | 795234 | EPIQ Elite Diagnostic Ultrasound System | PHILIPS ULTRASOUND, INC. | ||
26 | 00884838107533 | 795232 | EPIQ CVxi Ultrasound System | PHILIPS ULTRASOUND, INC. | ||
27 | 00884838107526 | 795231 | EPIQ CVx Ultrasound System | PHILIPS ULTRASOUND, INC. | ||
28 | 00884838107519 | 795206 | EPIQ 5W Ultrasound System | PHILIPS ULTRASOUND, INC. | ||
29 | 00884838107502 | 795204 | EPIQ 5 Ultrasound System | PHILIPS ULTRASOUND, INC. | ||
30 | 00884838107489 | 795202 | EPIQ 7W Ultrasound System | PHILIPS ULTRASOUND, INC. | ||
31 | 00884838107472 | 795122 | 9.0 and 9.0.x | EPIQ CVX Diamond Select | PHILIPS ULTRASOUND, INC. | |
32 | 00884838107465 | 795120 | EPIQ 5 Diamond Select Ultrasound System | PHILIPS ULTRASOUND, INC. | ||
33 | 00884838107458 | 795117 | EPIQ 7 Diamond Select Ultrasound System | PHILIPS ULTRASOUND, INC. | ||
34 | 00884838107441 | 795200 | EPIQ 7 Ultrasound System | PHILIPS ULTRASOUND, INC. | ||
35 | 00884838106628 | 795218 | Affiniti 30 Ultrasound System | PHILIPS ULTRASOUND, INC. | ||
36 | 00884838106611 | 795210 | Affiniti 70 Ultrasound System | PHILIPS ULTRASOUND, INC. | ||
37 | 00884838106604 | 795208 | Affiniti 50 Ultrasound System | PHILIPS ULTRASOUND, INC. | ||
38 | 00884838106598 | 795190 | Affiniti CVx Ultrasound System | PHILIPS ULTRASOUND, INC. | ||
39 | 00884838106581 | 795121 | Affiniti 30 Diamond Select Ultrasound System | PHILIPS ULTRASOUND, INC. | ||
40 | 00884838106574 | 795119 | Affiniti 70 Diamond Select Ultrasound System | PHILIPS ULTRASOUND, INC. | ||
41 | 00884838106567 | 795118 | Affiniti 50 Diamond Select Ultrasound System | PHILIPS ULTRASOUND, INC. | ||
42 | 00860005688111 | FG10594 | The NuVision Connector Cable is a non-sterile, reusable connector cable intended The NuVision Connector Cable is a non-sterile, reusable connector cable intended to connect the sterile, single-use NuVision ICE Catheter to a qualified GE ultrasound cardiac imaging system. | NuVision Connector Cable | NUVERA MEDICAL, INC. | |
43 | 00860005688104 | FG10593 | The NUVISION™ ICE Catheter is a diagnostic ultrasound imaging catheter designed The NUVISION™ ICE Catheter is a diagnostic ultrasound imaging catheter designed for intracardiac use. | NuVision ICE Catheter | NUVERA MEDICAL, INC. | |
44 | 00857595006418 | TVC-MC8 | TVC-MC8 | TVC Imaging System™The TVC Imaging System™ (TVC-MC8) is a dual-modality intravas TVC Imaging System™The TVC Imaging System™ (TVC-MC8) is a dual-modality intravascular imaging system that enables structural and chemical assessment of coronary arteries and plaques by using integrated NIRS (near infrared spectroscopy) and enhanced IVUS imaging technology to identify lipid-core plaques (LCP) of interest. The system utilizes proprietary NIRS analysis and 40MHz rotational IVUS imaging from a single catheter. The system is compatible with the TVC Insight™ Catheter Kit (TVC-C195-20) and TVC Insight Hydrophilic Catheter Kit (TVC-C195-22). The system can be configured for Extended Bandwidth™ making the system compatible with the TVC Insight XB™ Extended Bandwidth NIRS-IVUS Catheter Kit (TVC-C195-32) that provides NIRS and 50MHz rotational IVUS imaging.Indications for Use:1. The TVC Imaging System™ is intended for the near-infrared examination of coronary arteries in patients undergoing invasive coronary angiography. a. The System is intended for the detection of lipid-core-containing plaques of interest. b. The System is intended for the assessment of coronary artery lipid core burden. 2. The System is intended for ultrasound examination of coronary intravascular pathology. a. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal coronary interventional procedures. | TVC Imaging System™ | INFRAREDX, INC. |
45 | 00857595006401 | TVC-MC8 | TVC-MC8 | TVC Imaging System™The TVC Imaging System™ (TVC-MC8) is a dual-modality intravas TVC Imaging System™The TVC Imaging System™ (TVC-MC8) is a dual-modality intravascular imaging system that enables structural and chemical assessment of coronary arteries and plaques by using integrated NIRS (near infrared spectroscopy) and enhanced IVUS imaging technology to identify lipid-core plaques (LCP) of interest. The system utilizes proprietary NIRS analysis and 40MHz rotational IVUS imaging from a single catheter. The system is compatible with the TVC Insight™ Catheter Kit (TVC-C195-20) and TVC Insight Hydrophilic Catheter Kit (TVC-C195-22). The system can be configured for Extended Bandwidth™ making the system compatible with the TVC Insight XB™ Extended Bandwidth NIRS-IVUS Catheter Kit (TVC-C195-32) that provides NIRS and 50MHz rotational IVUS imaging. Non-RoHsIndications for Use:1. The TVC Imaging System™ is intended for the near-infrared examination of coronary arteries in patients undergoing invasive coronary angiography. a. The System is intended for the detection of lipid-core-containing plaques of interest. b. The System is intended for the assessment of coronary artery lipid core burden. 2. The System is intended for ultrasound examination of coronary intravascular pathology. a. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal coronary interventional procedures. | TVC Imaging System™ | INFRAREDX, INC. |
46 | 00857595006210 | TVC-C195-22 | TVC-C195-22 | Insight Hydrophilic Catheter™ Kit The TVC Insight Hydrophilic Catheter™ Kit (TVC Insight Hydrophilic Catheter™ Kit The TVC Insight Hydrophilic Catheter™ Kit (TVC-C195-22) is a single use, disposable coronary catheter and accessory kit designed for use only with the TVC Imaging System™ (TVC-MC8). The dual-modality intravascular imaging catheter combines laser-based near infrared spectroscopy (NIRS) and high fidelity 40 MHz ultrasonics for simultaneous acquisition of vessel structure and plaque composition—a single catheter, a single pullback, two sets of data. The catheter features a 40MHz wide bandwidth IVUS transducer and durable hydrophilic coating for improved delivery.Indications for Use:1. The TVC Imaging System™ is intended for the near-infrared examination of coronary arteries in patients undergoing invasive coronary angiography. a. The System is intended for the detection of lipid-core-containing plaques of interest. b. The System is intended for the assessment of coronary artery lipid core burden. 2. The System is intended for ultrasound examination of coronary intravascular pathology. a. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal coronary interventional procedures. | TVC Insight™ | INFRAREDX, INC. |
47 | 00857595006203 | TVC-C195-20 | TVC-C195-20 | Insight Catheter™ Kit The TVC Insight Catheter™ Kit (TVC-C195-20) is a single us Insight Catheter™ Kit The TVC Insight Catheter™ Kit (TVC-C195-20) is a single use, disposable coronary catheter and accessory kit designed for use only with the TVC Imaging System™ (TVC-MC8). The dual-modality intravascular imaging catheter combines laser-based near infrared spectroscopy (NIRS) and high fidelity 40 MHz ultrasonics for simultaneous acquisition of vessel structure and plaque composition—a single catheter, a single pullback, two sets of data. The catheter features a 40MHz wide bandwidth IVUS transducer.Indications for Use: 1. The TVC Imaging System™ is intended for the near-infrared examination of coronary arteries in patients undergoing invasive coronary angiography. a. The System is intended for the detection of lipid-core-containing plaques of interest. b. The System is intended for the assessment of coronary artery lipid core burden. 2. The System is intended for ultrasound examination of coronary intravascular pathology. a. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal coronary interventional procedures. | TVC Insight™ | INFRAREDX, INC. |
48 | 00849233017016 | 5084R2 | 5084R2 | Sterile Nerve Block | Busse Hospital Disposables | ROBERT BUSSE & CO., INC. |
49 | 00849233003729 | 1295 | 1295 | Epidural Tray | Busse Hospital Disposables | ROBERT BUSSE & CO., INC. |
50 | 00849233003644 | 1292 | 1292 | Universal Block Tray | Busse Hospital Disposables | ROBERT BUSSE & CO., INC. |