Other products from "INFRAREDX, INC."
No Primary DI Version or Model Catalog Number Device Description Product Code Product Code Name Device Class Brand Name
1 00857595006005 TVC-MC8-B1 TVC-MC8-B1 Individual Sterile Barrier for TVC-MC8 or TVC-MC9 System Controller IYO,OGZ System, Imaging, Pulsed Echo, Ultrasonic,Catheter, Intravascular, Plaque Morphol System, Imaging, Pulsed Echo, Ultrasonic,Catheter, Intravascular, Plaque Morphology Evaluation TVC Controller Sterile Barrier
2 00857595006425 TVC-MC9 TVC-MC9 TVC Imaging System™The TVC Imaging System™ (TVC-MC9) is a dual-modality intravas TVC Imaging System™The TVC Imaging System™ (TVC-MC9) 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 Extended Bandwidth™ IVUS imaging technology to identify lipid-core plaques (LCP) of interest. The system utilizes proprietary NIRS analysis and 50MHz Extended Bandwidth rotational IVUS imaging from a single catheter. The system features a touch screen control interface and a workflow that fits the complex catheterization laboratory environment. The system is compatible with the TVC Insight XB™ Extended Bandwidth NIRS-IVUS Catheter Kit (TVC-C195-32).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. IYO,OGZ System, Imaging, Pulsed Echo, Ultrasonic,Catheter, Intravascular, Plaque Morphol System, Imaging, Pulsed Echo, Ultrasonic,Catheter, Intravascular, Plaque Morphology Evaluation 2 TVC Imaging System™
3 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. OBJ,OGZ Catheter, Ultrasound, Intravascular,Catheter, Intravascular, Plaque Morphology Evaluation 2 TVC Imaging System™
4 00857595006234 TVC-C195-42 TVC-C195-42 The Dualpro™ IVUS+NIRS Imaging Catheter Kit (TVC-C195-42) is a single use, dispo The Dualpro™ IVUS+NIRS Imaging Catheter Kit (TVC-C195-42) is a single use, disposable coronary catheter and accessory kit designed for use only with the Makoto Intravascular Imaging System™ (TVC-MC10 and TVC-MC10i). The dual-modality intravascular imaging catheter combines 50 MHz Extended Bandwidth IVUS transducer and laser-based near infrared spectroscopy (NIRS) for simultaneous acquisition of vessel structure and plaque composition data— a single catheter, a single pullback, two sets of data. The Dualpro™ IVUS+NIRS Imaging Catheter features a durable hydrophilic coating for improved deliverability.Indications for Use:1. The Makoto Intravascular 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. IYO,OGZ System, Imaging, Pulsed Echo, Ultrasonic,Catheter, Intravascular, Plaque Morphol System, Imaging, Pulsed Echo, Ultrasonic,Catheter, Intravascular, Plaque Morphology Evaluation 2 Dualpro™ IVUS+NIRS Imaging Catheter Kit
5 04543660023515 GLGMF-YOK0A This angioplasty convenience kit contains one(1) sterile pouch with OKAY-II with This angioplasty convenience kit contains one(1) sterile pouch with OKAY-II with kit and one(1) sterile pouch with a GM-30 Inflation Device.The OKAY® II Y-Connector Set reduces blood loss during procedures through the use of a hemostatic valve not featured on conventional Y-connectors. Its large 3.33mm (10F) inner diameter facilitates a variety of PCI devices and techniques, and a new feature has been added that allows the one-touch style hemostatic valve to be locked in the open position. Includes Y-connector, torque device, and introducer. (YOK0A)The GM-30 30atm-25cc inflation device features standard length, 31 cm, high pressure tubing and 4 position stopcock for single or dual angioplasty balloon inflation and deflation. (GM-30NF)Indications for Use:1. The Y-connector is designed to work in conjunction with guiding catheters, etc. to reduce blood loss while assisting in manipulation of catheters, etc., injection of contrast solution from a side port, injection of medicine or saline solution, and measurement of blood pressure.2. The inflation device is recommended for use with balloon dilation catheters to create and monitor pressure in the balloon, and to deflate the balloon. PTM,DTL Syringe, Balloon Inflation, Exempt,Adaptor, Stopcock, Manifold, Fitting, Cardiop Syringe, Balloon Inflation, Exempt,Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass 2 GM-30 Accessory Kit
6 04543660023508 GLGMN-YOK0A This angioplasty convenience kit contains one(1) sterile pouch with OKAY-II with This angioplasty convenience kit contains one(1) sterile pouch with OKAY-II with kit and one(1) sterile pouch with a GM-30 Inflation Device.OKAY® II Y-Connector Set with Extension Tube reduces blood loss during procedures through the use of a hemostatic valve not featured on conventional Y connectors. Its large 3.33mm (10F) inner diameter facilitates a variety of PCI devices and techniques, and a new feature has been added that allows the one-touch style hemostatic valve to be locked in the open position. Includes Y-connector, torque device, and introducer. (YOK0A)The GM-30 30atm-25cc inflation device features standard length, 31 cm, high pressure tubing and 3 position stopcock for single angioplasty balloon inflation and deflation. (GM-30N)Indications for Use:1. The Y-connector is designed to work in conjunction with guiding catheters, etc. to reduce blood loss while assisting in manipulation of catheters, etc., injection of contrast solution from a side port, injection of medicine or saline solution, and measurement of blood pressure.2. The inflation device is recommended for use with balloon dilation catheters to create and monitor pressure in the balloon, and to deflate the balloon. PTM,DTL Syringe, Balloon Inflation, Exempt,Adaptor, Stopcock, Manifold, Fitting, Cardiop Syringe, Balloon Inflation, Exempt,Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass 2 GM-30 Accessory Kit
7 04543660023492 GLGMF-YOK0E This angioplasty convenience kit contains one(1) sterile pouch with OKAY-II with This angioplasty convenience kit contains one(1) sterile pouch with OKAY-II with kit and extension tube and one(1) sterile pouch with a GM-30 Inflation Device.OKAY® II Y-Connector Set with Extension Tube reduces blood loss during procedures through the use of a hemostatic valve not featured on conventional Y connectors. Its large 3.33mm (10F) inner diameter facilitates a variety of PCI devices and techniques, and a new feature has been added that allows the one-touch style hemostatic valve to be locked in the open position. Includes Y-connector, torque device, introducer, and extension tube. (YOK0E)The GM-30 30atm-25cc inflation device features standard length, 31 cm, high pressure tubing and 4 position stopcock for single or dual angioplasty balloon inflation and deflation. (GM-30NF)Indications for Use:1. The Y-connector is designed to work in conjunction with guiding catheters, etc. to reduce blood loss while assisting in manipulation of catheters, etc., injection of contrast solution from a side port, injection of medicine or saline solution, and measurement of blood pressure.2. The inflation device is recommended for use with balloon dilation catheters to create and monitor pressure in the balloon, and to deflate the balloon. PTM,DTL Syringe, Balloon Inflation, Exempt,Adaptor, Stopcock, Manifold, Fitting, Cardiop Syringe, Balloon Inflation, Exempt,Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass 2 GM-30 Accessory Kit
8 04543660023485 GLGMN-YOK0E This angioplasty convenience kit contains one(1) sterile pouch with OKAY-II with This angioplasty convenience kit contains one(1) sterile pouch with OKAY-II with kit and extension tube and one(1) sterile pouch with a GM-30 Inflation Device.OKAY® II Y-Connector Set with Extension Tube reduces blood loss during procedures through the use of a hemostatic valve not featured on conventional Y connectors. Its large 3.33mm (10F) inner diameter facilitates a variety of PCI devices and techniques, and a new feature has been added that allows the one-touch style hemostatic valve to be locked in the open position. Includes Y-connector, torque device, introducer, and extension tube. (YOK0E)The GM-30 30atm-25cc inflation device features standard length, 31 cm, high pressure tubing and 3 position stopcock for single angioplasty balloon inflation and deflation. (GM-30N)Indications for Use:1. The Y-connector is designed to work in conjunction with guiding catheters, etc. to reduce blood loss while assisting in manipulation of catheters, etc., injection of contrast solution from a side port, injection of medicine or saline solution, and measurement of blood pressure.2. The inflation device is recommended for use with balloon dilation catheters to create and monitor pressure in the balloon, and to deflate the balloon. PTM,DTL Syringe, Balloon Inflation, Exempt,Adaptor, Stopcock, Manifold, Fitting, Cardiop Syringe, Balloon Inflation, Exempt,Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass 2 GM-30 Accessory Kit
9 04543660022341 YOK0B OKAY II reduces blood loss during procedures through the use of a hemostatic val OKAY II reduces blood loss during procedures through the use of a hemostatic valve not featured on conventional Y connectors. Its large 3.33mm (10F) inner diameter facilitates a variety of PCI devices and techniques, and a new feature has been added that allows the one-touch style hemostatic valve to be locked in the open position. Includes Y-connector.Indications for Use:1. This product is designed to work in conjunction with guiding catheters, etc. to reduce blood loss while assisting in manipulation of catheters, etc., injection of contrast solution from a side port, injection of medicine or saline solution, and measurement of blood pressure. DTL Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass OKAY® II Y-Connector
10 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. OBJ,OGZ Catheter, Ultrasound, Intravascular,Catheter, Intravascular, Plaque Morphology Evaluation TVC Insight™
11 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. IYO,OBJ,OGZ System, Imaging, Pulsed Echo, Ultrasonic,Catheter, Ultrasound, Intravascular,Cat System, Imaging, Pulsed Echo, Ultrasonic,Catheter, Ultrasound, Intravascular,Catheter, Intravascular, Plaque Morphology Evaluation TVC Insight™
12 04543660022662 GM-30NL GM-30NL 30atm-25cc Inflation Device. Features extended length, 76 cm, high pressure tubi 30atm-25cc Inflation Device. Features extended length, 76 cm, high pressure tubing and 3 position stopcock for balloon inflation and deflation.Indications for Use:1. This device is recommended for use with balloon dilation catheters to create and monitor pressure in the balloon, and to deflate the balloon. PTM Syringe, Balloon Inflation, Exempt 2 GM-30 Inflation Device
13 04543660022655 GM-30NF GM-30NF 30atm-25cc Inflation Device. Features standard length, 31 cm, high pressure tubi 30atm-25cc Inflation Device. Features standard length, 31 cm, high pressure tubing and 4 position stopcock for single or dual angioplasty balloon inflation and deflation.Indications for Use:1. This device is recommended for use with balloon dilation catheters to create and monitor pressure in the balloon, and to deflate the balloon. PTM Syringe, Balloon Inflation, Exempt 2 GM-30 Inflation Device
14 04543660022648 GM-30N GM-30N 30atm-25cc Inflation Device. Features standard length, 31 cm, high pressure tubi 30atm-25cc Inflation Device. Features standard length, 31 cm, high pressure tubing and 3 position stopcock for angioplasty balloon inflation and deflation.Indications for Use:1. This device is recommended for use with balloon dilation catheters to create and monitor pressure in the balloon, and to deflate the balloon. PTM Syringe, Balloon Inflation, Exempt 2 GM-30 Inflation Device
15 04543660022334 YOK0A OKAY II reduces blood loss during procedures through the use of a hemostatic val OKAY II reduces blood loss during procedures through the use of a hemostatic valve not featured on conventional Y connectors. Its large 3.33mm (10F) inner diameter facilitates a variety of PCI devices and techniques, and a new feature has been added that allows the one-touch style hemostatic valve to be locked in the open position. Includes Y-connector, torque device, and introducer.Indications for Use:1. This product is designed to work in conjunction with guiding catheters, etc. to reduce blood loss while assisting in manipulation of catheters, etc., injection of contrast solution from a side port, injection of medicine or saline solution, and measurement of blood pressure. DTL Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass OKAY® II Y-Connector Set
16 04543660022358 YOK0E OKAY II reduces blood loss during procedures through the use of a hemostatic val OKAY II reduces blood loss during procedures through the use of a hemostatic valve not featured on conventional Y connectors. Its large 3.33mm (10F) inner diameter facilitates a variety of PCI devices and techniques, and a new feature has been added that allows the one-touch style hemostatic valve to be locked in the open position. Includes Y-connector, torque device, introducer, and extension tube.Indications for Use:1. This product is designed to work in conjunction with guiding catheters, etc. to reduce blood loss while assisting in manipulation of catheters, etc., injection of contrast solution from a side port, injection of medicine or saline solution, and measurement of blood pressure. DTL Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass OKAY® II Y-Connector Set with Extension Tube
17 00857595006227 TVC-C195-32 TVC-C195-32 Insight XB™ Catheter KitThe TVC Insight XB™ Extended Bandwidth™ NIRS-IVUS Cathet Insight XB™ Catheter KitThe TVC Insight XB™ Extended Bandwidth™ NIRS-IVUS Catheter Kit (TVC-C195-32) is a single use, disposable coronary catheter and accessory kit designed for use only with the TVC Imaging System™(TVC-MC9, TVC-MC9i, and properly configured TVC-MC8). The dual-modality intravascular imaging catheter combines laser-based near infrared spectroscopy (NIRS) and 50 MHz Extended Bandwidth ultrasonics for simultaneous acquisition of vessel structure and plaque composition— a single catheter, a single pullback, two sets of data. The Insight XB catheter features a 50MHz Extended 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. IYO,OGZ System, Imaging, Pulsed Echo, Ultrasonic,Catheter, Intravascular, Plaque Morphol System, Imaging, Pulsed Echo, Ultrasonic,Catheter, Intravascular, Plaque Morphology Evaluation TVC Insight XB™
18 00857595006623 TVC-MC9i TVC-MC9i TThe TVC Integrated Imaging System™ (TVC-MC9i) is a dual-modality intravascular TThe TVC Integrated Imaging System™ (TVC-MC9i) 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 Extended Bandwidth™ IVUS imaging technology to identify lipid-core plaques (LCP) of interest. The system utilizes proprietary NIRS analysis and 50MHz Extended Bandwidth rotational IVUS imaging from a single catheter. This model of TVC Imaging System is designed to be installed in the catheterization laboratory and minimize usage of space. The system features a touch screen control interface and a workflow that fits the complex catheterization laboratory environment. The system is compatible with the TVC Insight XB™ Extended Bandwidth NIRS-IVUS Catheter Kit (TVC-C195-32). 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. IYO,OGZ System, Imaging, Pulsed Echo, Ultrasonic,Catheter, Intravascular, Plaque Morphol System, Imaging, Pulsed Echo, Ultrasonic,Catheter, Intravascular, Plaque Morphology Evaluation 2 TVC Integrated Imaging System™
19 00857595006432 TVC-MC10 TVC-MC10 The Makoto Intravascular Imaging System™ (TVC-MC10) is a dual-modality intravasc The Makoto Intravascular Imaging System™ (TVC-MC10) is a dual-modality intravascular imaging system that enables structural and chemical assessment of coronary arteries and plaques by using integrated Extended Bandwidth IVUS imaging and NIRS (near infrared spectroscopy) technologies to identify lipid-core plaques (LCP) of interest. The system utilizes proprietary NIRS analysis and 50 MHz Extended Bandwidth rotational IVUS imaging from a single catheter. The system features a touch screen control interface and a workflow that fits the complex catheterization laboratory environment. The system is compatible with the Dualpro™ IVUS+NIRS Imaging Catheter Kit (TVC-C195-42). Indications for Use:1. The Makoto Intravascular 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. IYO,OGZ System, Imaging, Pulsed Echo, Ultrasonic,Catheter, Intravascular, Plaque Morphol System, Imaging, Pulsed Echo, Ultrasonic,Catheter, Intravascular, Plaque Morphology Evaluation 2 Makoto Intravascular Imaging System™
Other products with the same Product Codes "OBJ, OGZ"
No Primary DI Version or Model Catalog Number Device Description Brand Name Organization Name
1 00801902111470 IPN036055 ASK-04001-DU10 Arrow(R) VPS(R) Access Kit for use with 4 Fr. Peripherally Inserted Central Veno Arrow(R) VPS(R) Access Kit for use with 4 Fr. Peripherally Inserted Central Venous Catheter ARROW TELEFLEX INCORPORATED
2 00801902111463 IPN036054 ASK-04001-DU9 Arrow(R) VPS(R) Access Kit for use with 5 Fr. Peripherally Inserted Central Veno Arrow(R) VPS(R) Access Kit for use with 5 Fr. Peripherally Inserted Central Venous Catheter ARROW TELEFLEX INCORPORATED
3 00801902091871 IPN035990 VSNCSPCW3A Vascular Positioning System (R) VPS (R) Console with Accessories ARROW TELEFLEX INCORPORATED
4 00801902091857 IPN035985 VPS-G4SEC VPS G4 (TM) Device Stylet Extension Cable ARROW TELEFLEX INCORPORATED
5 00801902089830 IPN034231 ASK-04001-UOC Arrow(R) VPS(R) Access Kit with Sharps Safety Features ARROW TELEFLEX INCORPORATED
6 00801902078407 IPN035995 VSNEKGLEAA VPS (R) Device ECG Lead Set (3 Lead) RoHS ARROW TELEFLEX INCORPORATED
7 00628055603108 SA-10-0029 Imaging catheter accessories Novasight Hybrid™ Catheter PIM Bag CONAVI MEDICAL INC
8 00628055603085 TA-07-0001 Imaging System Novasight Hybrid™ PIM CONAVI MEDICAL INC
9 00628055603078 TA-03-0005 Imaging System Novasight Hybrid™ Hummingbird Console CONAVI MEDICAL INC
10 00628055603061 SA-10-0022 Imaging catheter accessories Novasight Hybrid™ Catheter Accessories Package CONAVI MEDICAL INC
11 00628055603054 TA-06-0001 Imaging catheter Novasight Hybrid™ Catheter CONAVI MEDICAL INC
12 00195278516343 E v203 v204 to v206 UPG Vivid E95, E90, E80 v203 v204 to v206 UPG Vivid GE VINGMED ULTRASOUND AS
13 00195278505354 E90 v206 Vivid E90 v206 Vivid GE VINGMED ULTRASOUND AS
14 00195278505347 E80 v206 Vivid E80 v206 Vivid GE VINGMED ULTRASOUND AS
15 00195278505330 E95 v206 Vivid E95 v206 Vivid GE VINGMED ULTRASOUND AS
16 00184360000709 806302012 s5i Control Console VOLCANO CORPORATION
17 00184360000525 807301001 s5 PC Module VOLCANO CORPORATION
18 00184360000358 89000 Revolution 45MHz Rotational IVUS Imaging Catheter PHILIPS IMAGE GUIDED THERAPY CORPORATION
19 40841716102101 016375 ACI Hardware, HDi System p/n 801085-001Contents: ACI Hardware ACIST HDi® HD IVUS System ACIST MEDICAL SYSTEMS, INC.
20 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 ACIST HDi® HD IVUS System ACIST MEDICAL SYSTEMS, INC.
21 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 ACIST HDi® HD IVUS System ACIST MEDICAL SYSTEMS, INC.
22 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 ACIST HDi® HD IVUS System ACIST MEDICAL SYSTEMS, INC.
23 40841716101180 017986 HDi System Overpack p/n 800994-002Contents: System Console, Linear Translation S HDi System Overpack p/n 800994-002Contents: System Console, Linear Translation System (LTS), Patient Interface Module (PIM), Power Supply ACIST HDi® HD IVUS System ACIST MEDICAL SYSTEMS, INC.
24 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 ACIST HDi® HD IVUS System ACIST MEDICAL SYSTEMS, INC.
25 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 ACIST HDi® HD IVUS System ACIST MEDICAL SYSTEMS, INC.
26 40801902129817 IPN035973 VPS7220B ARROW(R) VPS® (Vascular Positioning System) Bedside Procedure Kit ARROW TELEFLEX INCORPORATED
27 40801902124300 IPN035993 VSNCSPCW3A-R Vascular Positioning System (R) VPS (R) Console with Accessories ARROW TELEFLEX INCORPORATED
28 30801902130267 IPN037703 VPS-G4C-R VPS G4(TM) Base Unit and Interface with Accessories-Refurbished ARROW TELEFLEX INCORPORATED
29 30801902129247 IPN035977 VPS-G4C-R VPS G4(TM) Base Unit and Interface with Accessories-Refurbished ARROW TELEFLEX INCORPORATED
30 30801902129230 IPN035976 VPS-G4C VPS G4(TM) Base Unit and Interface with Accessories ARROW TELEFLEX INCORPORATED
31 NRP014 R-014R R-014R The device is the Philips Vision PV .014P RX Digital IVUS catheter that is repro The device is the Philips Vision PV .014P RX Digital IVUS catheter that is reprocessed by Northeast Scientific, Inc. (NES). NES Reprocessed Visions PV .014P RX Digital IVUS Catheter NORTH EAST SCIENTIFIC INC
32 10846835008869 10439236 10439236 SOUNDSTAR BIOSENSE WEBSTER INC
33 10846835008852 10439011 10439011 SOUNDSTAR BIOSENSE WEBSTER INC
34 10846835008845 10439072 10439072 SOUNDSTAR BIOSENSE WEBSTER INC
35 10846835008838 10438577 10438577 SOUNDSTAR BIOSENSE WEBSTER INC
36 10846835000153 SNDSTR10G SNDSTR10G SOUNDSTAR BIOSENSE WEBSTER INC
37 10846835000139 SNDSTR10 SNDSTR10 SOUNDSTAR BIOSENSE WEBSTER INC
38 10841716102148 017987 HDi System Console, p/n 701460-006 ACIST HDi® System Console ACIST MEDICAL SYSTEMS, INC.
39 10841716101851 017987 HDi System Console, p/n 701460-005 ACIST HDi® System Console ACIST MEDICAL SYSTEMS, INC.
40 10841716101592 017989 HDi PIM, p/n 701446-004 ACIST HDi® Patient Interface Module (PIM) ACIST MEDICAL SYSTEMS, INC.
41 10841716101332 018196 HDi Bed Rail Mount, p/n 701575-002 ACIST HDi® Bed Rail Mount ACIST MEDICAL SYSTEMS, INC.
42 10841716101202 017991 HDi Cart, p/n 205046-005 ACIST HDi® Cart ACIST MEDICAL SYSTEMS, INC.
43 10841716101172 017990 HDi Power Supply, p/n 701560-002 ACIST HDi® Power Supply ACIST MEDICAL SYSTEMS, INC.
44 10841716101165 017988 HDi LTS, p/n 701457-003 ACIST HDi® Linear Translation System (LTS) ACIST MEDICAL SYSTEMS, INC.
45 10841716101158 017989 HDi PIM, p/n 701446-003 ACIST HDi® Patient Interface Module (PIM) ACIST MEDICAL SYSTEMS, INC.
46 10841716101141 017986 HDi System Console, p/n 701460-003 ACIST HDi® System Console ACIST MEDICAL SYSTEMS, INC.
47 10841716100779 018196 HDi Bed Rail Mount, p/n 701575-001 ACIST HDi® Bed Rail Mount ACIST MEDICAL SYSTEMS, INC.
48 10841716100755 017788 Kodama Catheter, p/n 701470-001Contents: Imaging catheter, 3 mL syringe, 10 mL s Kodama Catheter, p/n 701470-001Contents: Imaging catheter, 3 mL syringe, 10 mL syringe, Extension set, Sterile bag, IFU ACIST Kodama® Coronary Imaging Catheter ACIST MEDICAL SYSTEMS, INC.
49 10841716100694 017988 HDi LTS, p/n 701457-004 ACIST HDi® Linear Translation System (LTS) ACIST MEDICAL SYSTEMS, INC.
50 10841716100250 017986 HDi System Console, p/n 701460-004 ACIST HDi® System Console ACIST MEDICAL SYSTEMS, INC.