No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 00850027837192 | 800698 | 800698 | SmartAblate™ Adapter Cable AcQMap to Catheter | DQK,IYO,ITX | Computer, Diagnostic, Programmable,System, Imaging, Pulsed Echo, Ultrasonic,Tran Computer, Diagnostic, Programmable,System, Imaging, Pulsed Echo, Ultrasonic,Transducer, Ultrasonic, Diagnostic | 2 | AcQMap |
2 | 00857042007999 | 900000 | 900000 | AcQMap System | DQK,IYO,ITX | Computer, Diagnostic, Programmable,System, Imaging, Pulsed Echo, Ultrasonic,Tran Computer, Diagnostic, Programmable,System, Imaging, Pulsed Echo, Ultrasonic,Transducer, Ultrasonic, Diagnostic | 2 | AcQMap |
3 | 00857042007920 | 900100 | 900100 | AcQMap System Console 2.0 | DQK,IYO,ITX | Computer, Diagnostic, Programmable,System, Imaging, Pulsed Echo, Ultrasonic,Tran Computer, Diagnostic, Programmable,System, Imaging, Pulsed Echo, Ultrasonic,Transducer, Ultrasonic, Diagnostic | 2 | AcQMap |
4 | 00857042007562 | 800605 | 800605 | AcQMap Patient Electrode Kit | DQK,IYO,ITX | Computer, Diagnostic, Programmable,System, Imaging, Pulsed Echo, Ultrasonic,Tran Computer, Diagnostic, Programmable,System, Imaging, Pulsed Echo, Ultrasonic,Transducer, Ultrasonic, Diagnostic | 2 | AcQMap |
5 | 00857042007425 | 800604 | 800604 | AcQMap Auxiliary Interface Box, Console 2.0 | DQK,IYO,ITX | Computer, Diagnostic, Programmable,System, Imaging, Pulsed Echo, Ultrasonic,Tran Computer, Diagnostic, Programmable,System, Imaging, Pulsed Echo, Ultrasonic,Transducer, Ultrasonic, Diagnostic | 2 | AcQMap |
6 | 00857042007418 | 800530 | 800530 | AcQMap Catheter Interface Cable | MTD,ITX | Catheter, Intracardiac Mapping, High-Density Array,Transducer, Ultrasonic, Diagnostic | 2 | AcQMap |
7 | 00857042007401 | 900009 | 900009 | AcQMap 3D Imaging & Mapping Catheter | MTD,ITX | Catheter, Intracardiac Mapping, High-Density Array,Transducer, Ultrasonic, Diagnostic | 2 | AcQMap |
8 | 00857042007364 | 800405 | 800405 | POAG Cable MC-POAG-EC6/2 | DQK,IYO,ITX | Computer, Diagnostic, Programmable,System, Imaging, Pulsed Echo, Ultrasonic,Tran Computer, Diagnostic, Programmable,System, Imaging, Pulsed Echo, Ultrasonic,Transducer, Ultrasonic, Diagnostic | 2 | AcQMap |
9 | 00857042007357 | 800255 | 800255 | Workstation Cable | DQK,ITX,IYO | Computer, Diagnostic, Programmable,Transducer, Ultrasonic, Diagnostic,System, Im Computer, Diagnostic, Programmable,Transducer, Ultrasonic, Diagnostic,System, Imaging, Pulsed Echo, Ultrasonic | 2 | AcQMap |
10 | 00857042007333 | 800601 | 800601 | Power Cord, Console 2.0 | DQK,IYO,ITX | Computer, Diagnostic, Programmable,System, Imaging, Pulsed Echo, Ultrasonic,Tran Computer, Diagnostic, Programmable,System, Imaging, Pulsed Echo, Ultrasonic,Transducer, Ultrasonic, Diagnostic | 2 | AcQMap |
11 | 00857042007326 | 800505 | 800505 | AcQMap Ablation Reference Cable | DQK | Computer, Diagnostic, Programmable | 2 | AcQMap |
12 | 00857042007319 | 800508 | 800508 | AcQMap Ablation Electrogram Cable | DQK | Computer, Diagnostic, Programmable | 2 | AcQMap |
13 | 00857042007302 | 800422 | 800422 | AcQMap Auxiliary Interface Box | DQK | Computer, Diagnostic, Programmable | 2 | AcQMap |
14 | 00857042007296 | 800500 | 800500 | AcQMap Console | DQK | Computer, Diagnostic, Programmable | 2 | AcQMap |
15 | 00857042007289 | 800520 | 800520 | AcQMap Workstation | DQK | Computer, Diagnostic, Programmable | 2 | AcQMap |
16 | 00857042007272 | 800523 | 800523 | AcQMap 2mm Pin Jumper St | DQK | Computer, Diagnostic, Programmable | 2 | AcQMap |
17 | 00857042007265 | 800522 | 800522 | AcQMap ECG w/Snaps Cable | DQK | Computer, Diagnostic, Programmable | 2 | AcQMap |
18 | 00857042007258 | 800524 | 800524 | AcQMap ECG POST Cable | DQK | Computer, Diagnostic, Programmable | 2 | AcQMap |
19 | 00857042007241 | 800421 | 800421 | AcQMap ECG Input Cable | DQK | Computer, Diagnostic, Programmable | 2 | AcQMap |
20 | 00857042007234 | 800424 | 800424 | AcQMap ECG Output Cable | DQK | Computer, Diagnostic, Programmable | 2 | AcQMap |
21 | 00857042007135 | 800431 | 800431 | Ampere® Adapter Cable AcQMap®→ Ampere | DQK | Computer, Diagnostic, Programmable | 2 | AcQMap |
22 | 00857042007128 | 800407 | 800407 | AcQMap® Surface ECG Cable | DQK | Computer, Diagnostic, Programmable | 2 | AcQMap |
23 | 00857042007111 | 800109 | 800109 | AcQMap® Auxiliary Catheter Cable | DQK | Computer, Diagnostic, Programmable | 2 | AcQMap |
24 | 00857042007104 | 800112 | 800112 | AcQMap® Ablation Interface Unit Cable | DQK | Computer, Diagnostic, Programmable | 2 | AcQMap |
25 | 00857042007098 | 800113 | 800113 | AcQMap® Patient Interface Unit Cable | DQK | Computer, Diagnostic, Programmable | 2 | AcQMap |
26 | 00857042007081 | 800229 | 800229 | AcQMap® Patient Interface Unit | DQK | Computer, Diagnostic, Programmable | 2 | AcQMap |
27 | 00857042007074 | 800430 | 800430 | Ampere® Adapter CableAcQMap® → Ablation Catheter | DQK | Computer, Diagnostic, Programmable | 2 | AcQMap |
28 | 00857042007067 | 800244-001 | 800244-001 | AcQMap® Ablation Interface Unit | DQK | Computer, Diagnostic, Programmable | 2 | AcQMap |
29 | 00857042007050 | 800254 | 800254 | AcQMap® Workstation | DQK | Computer, Diagnostic, Programmable | 2 | AcQMap |
30 | 00857042007043 | 800258 | 800258 | AcQMap® Console | DQK | Computer, Diagnostic, Programmable | 2 | AcQMap |
31 | 00857042007036 | 800365-002 | 800365-002 | AcQMap® Patient Electrode Kit | DRX | Electrode, Electrocardiograph | AcQMap | |
32 | 00857042007029 | 900003 | 900003 | AcQMap® 3D Imaging & Mapping Catheter | MTD | Catheter,Intracardiac Mapping,High-Density Array | 2 | AcQMap |
33 | 00857042007005 | 800426 | 800426 | North America Power Cord | DQK | Computer, Diagnostic, Programmable | 2 | AcQMap |
34 | 00850027837482 | 800748 | 800748 | Maestro Adapter Cable, AcQMap to Catheter | DQK,ITX,IYO | Computer, Diagnostic, Programmable,Transducer, Ultrasonic, Diagnostic,System, Im Computer, Diagnostic, Programmable,Transducer, Ultrasonic, Diagnostic,System, Imaging, Pulsed Echo, Ultrasonic | 2 | AcQMap |
35 | 00850027837475 | 800745 | 800745 | Maestro Adapter Cable, AcQMap to Generator | DQK,IYO,ITX | Computer, Diagnostic, Programmable,System, Imaging, Pulsed Echo, Ultrasonic,Tran Computer, Diagnostic, Programmable,System, Imaging, Pulsed Echo, Ultrasonic,Transducer, Ultrasonic, Diagnostic | 2 | AcQMap |
36 | 00850027837468 | 800742 | 800742 | Adapter Cable-Long, Ablation Adapter to AcQMap | DQK,IYO,ITX | Computer, Diagnostic, Programmable,System, Imaging, Pulsed Echo, Ultrasonic,Tran Computer, Diagnostic, Programmable,System, Imaging, Pulsed Echo, Ultrasonic,Transducer, Ultrasonic, Diagnostic | 2 | AcQMap |
37 | 00850027837451 | 800739 | 800739 | Adapter Cable-Short, Ablation Adapter to AcQMap | DQK,ITX,IYO | Computer, Diagnostic, Programmable,Transducer, Ultrasonic, Diagnostic,System, Im Computer, Diagnostic, Programmable,Transducer, Ultrasonic, Diagnostic,System, Imaging, Pulsed Echo, Ultrasonic | 2 | AcQMap |
38 | 00850027837444 | 800710 | 800710 | Carto Force Adapter Cable Shipping Assembly | DQK,IYO,ITX | Computer, Diagnostic, Programmable,System, Imaging, Pulsed Echo, Ultrasonic,Tran Computer, Diagnostic, Programmable,System, Imaging, Pulsed Echo, Ultrasonic,Transducer, Ultrasonic, Diagnostic | 2 | AcQMap |
39 | 00850027837246 | 800697 | 800697 | AcQMap to Maestro Generator Adapter | DQK,IYO,ITX | Computer, Diagnostic, Programmable,System, Imaging, Pulsed Echo, Ultrasonic,Tran Computer, Diagnostic, Programmable,System, Imaging, Pulsed Echo, Ultrasonic,Transducer, Ultrasonic, Diagnostic | 2 | AcQMap |
40 | 00850027837239 | 800696 | 800696 | AcQMap to SmartAblate Generator Adapter | DQK,IYO,ITX | Computer, Diagnostic, Programmable,System, Imaging, Pulsed Echo, Ultrasonic,Tran Computer, Diagnostic, Programmable,System, Imaging, Pulsed Echo, Ultrasonic,Transducer, Ultrasonic, Diagnostic | 2 | AcQMap |
41 | 00850027837222 | 800695 | 800695 | AcQMap to SmartAblate Generator Adapter | DQK,IYO,ITX | Computer, Diagnostic, Programmable,System, Imaging, Pulsed Echo, Ultrasonic,Tran Computer, Diagnostic, Programmable,System, Imaging, Pulsed Echo, Ultrasonic,Transducer, Ultrasonic, Diagnostic | 2 | AcQMap |
42 | 00857042007517 | 222852 | 222852 | AcQGuide Flex RF 65 cm Med Curl | DYB | Introducer, Catheter | 2 | AcQGuide Flex |
43 | 00857042007500 | 012852 | 012852 | AcQGuide Mini-S, 65cm - L2 with AcQCross QX | DYB | Introducer, Catheter | 2 | AcQGuide Mini-S |
44 | 00850027837161 | 900305 | 900305 | AcQCross Qx - MAX 70cm | DYB | Introducer, Catheter | 2 | AcQCross Qx |
45 | 00850027837147 | 900304 | 900304 | AcQCross Qx - FC 65cm | DYB | Introducer, Catheter | 2 | AcQCross Qx |
46 | 00850027837123 | 900303 | 900303 | AcQCross Qx - VZ 71cm | DYB | Introducer, Catheter | 2 | AcQCross Qx |
47 | 00850027837659 | 900218 | 900218 | StabilICE | HYA,DWS | Forceps, Wire Holding,Instruments, Surgical, Cardiovascular | 1 | StabilICE |
48 | 00850027837642 | 900221 | 900221 | StabilICE | HYA,DWS | Forceps, Wire Holding,Instruments, Surgical, Cardiovascular | 1 | StabilICE |
49 | 00850027837611 | 900309 | DYB,DRE | Introducer, Catheter,Dilator, Vessel, For Percutaneous Catheterization | 2 | AcQCross Qx Integrated Transseptal Dilator/Needle | ||
50 | 00850027837598 | 900308 | DYB,DRE | Introducer, Catheter,Dilator, Vessel, For Percutaneous Catheterization | 2 | AcQCross Qx Integrated Transseptal Dilator/Needle |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | B995LI10050 | LI-1005 | Velacur is a portable ultrasonic elastography machine used to assess and monitor Velacur is a portable ultrasonic elastography machine used to assess and monitor chronic liver diseases. The device is comprised of a control unit, activation unit, and ultrasound probe. A carrying case is also provided. | Velacur | SONIC INCYTES MEDICAL CORP. | |
2 | B995LI10050 | LI-1005 | Velacur is a portable ultrasonic elastography machine used to assess and monitor Velacur is a portable ultrasonic elastography machine used to assess and monitor chronic liver diseases. The device is comprised of a control unit, activation unit, and ultrasound probe. A carrying case is also provided. | Velacur | SONIC INCYTES MEDICAL CORP. | |
3 | B972CCZ12050482050 | 4 | CCZ1205048205 | CER-S is stand-alone software medical device, providing advanced solutions for i CER-S is stand-alone software medical device, providing advanced solutions for importing, analyzing, editing, reviewing and generating clinical reports related to digital continuous ECG recordings (Holters). CER-S does not carry out an automated interpretation of the ECG data. | CER-S | CARDIO CALM SRL |
4 | B972CCZ12050482030 | 4 | CER-S is stand-alone software medical device, providing advanced solutions for i CER-S is stand-alone software medical device, providing advanced solutions for importing, analyzing, editing, reviewing and generating clinical reports related to digital continuous ECG recordings (Holters). CER-S does not carry out an automated interpretation of the ECG data. | CER-S | CARDIO CALM SRL | |
5 | B748AR350050DUS0 | AR-3500-50D-US | Sterile ultrasound probe cover and ultrasound gel. | Synergy MSK Ultrasound Strl Cover & Parker Gel | SAFERSONIC MEDIZINPRODUKTE HANDELS GMBH | |
6 | B748AR350050DEU0 | AR-3500-50D-US | Sterile ultrasound probe cover and ultrasound gel. | Synergy MSK Ultrasound Strl Cover & Parker Gel | SAFERSONIC MEDIZINPRODUKTE HANDELS GMBH | |
7 | B616UVXS0 | XS | General Purpose Diagnostic Medical Ultrasonic Imaging System | UltraVision | ULTRAVISION CORPORATION | |
8 | B616UVXR0 | XR | General Purpose Diagnostic Medical Ultrasonic Imaging System | UltraVision | ULTRAVISION CORPORATION | |
9 | B616UVXP0 | XP | General Purpose Diagnostic Medical Ultrasonic Imaging System | UltraVision | ULTRAVISION CORPORATION | |
10 | B616UVTKL1440 | Konica Linear Probe L14-4 | n/a | Linear Ultrasonic Transducer | UltraVision | ULTRAVISION CORPORATION |
11 | B616UVTKHL1840 | Konica Hockey Stick Linear 18-4 | n/a | Linear Ultrasonic Transducer | UltraVision | ULTRAVISION CORPORATION |
12 | B616UVTKCC520 | Konica Curved Probe C5-2 | n/a | Curved Ultrasonic Transducer | UltraVision | ULTRAVISION CORPORATION |
13 | B546VENDYS1 | JK-001V | VENDYS II | ENDOTHELIX, INC. | ||
14 | B510DUS70000 | DUS-7000 | ADVANCED ULTRASOUND | ADVANCED INSTRUMENTATIONS, INC. | ||
15 | B510DUS70000 | DUS-7000 | ADVANCED ULTRASOUND | ADVANCED INSTRUMENTATIONS, INC. | ||
16 | B510DUS5000A1 | DUS-5000 | ADVANCED ULTRASOUND | ADVANCED INSTRUMENTATIONS, INC. | ||
17 | B510DUS5000A1 | DUS-5000 | ADVANCED ULTRASOUND | ADVANCED INSTRUMENTATIONS, INC. | ||
18 | B510DUS30001 | DUS-3000 | ADVANCED ULTRASOUND | ADVANCED INSTRUMENTATIONS, INC. | ||
19 | B510DUS30001 | DUS-3000 | ADVANCED ULTRASOUND | ADVANCED INSTRUMENTATIONS, INC. | ||
20 | B41278000 | 1 | 7800 | The Varia Transcranial Doppler Ultrasound (TCD) device provides precision measur The Varia Transcranial Doppler Ultrasound (TCD) device provides precision measurements of cerebrovascular blood flow. Designed to exacting standards, Varia delivers excellent signal quality with minimal ambient noise, allowing clinicians to easily locate vessels and obtain high-quality measurements. When attached to an external MS Windows-based computer, Varia presents the clinician with an intuitive interface including clear displays and easy-to-use input parameters to facilitate a quality exam.Utilized with software only device accessory Varia-NCI. | Varia TCD | NEUROCHAOS SOLUTIONS INC |
21 | B377GMD61VASUS40 | Vascular V4 | GMD61VASUS4 | USB ultrasound probe, general purpose/vascular | ClearProbe | GLOBALMEDIA GROUP, LLC |
22 | B377GMD61VASUS40 | Vascular V4 | GMD61VASUS4 | USB ultrasound probe, general purpose/vascular | ClearProbe | GLOBALMEDIA GROUP, LLC |
23 | B377GMD61ENDUS40 | Endocavity V4 | GMD61ENDUS4 | USB ultrasound probe, general purpose/endocavity. | ClearProbe | GLOBALMEDIA GROUP, LLC |
24 | B377GMD61ENDUS40 | Endocavity V4 | GMD61ENDUS4 | USB ultrasound probe, general purpose/endocavity. | ClearProbe | GLOBALMEDIA GROUP, LLC |
25 | B377GMD61ABDUS40 | Abdominal V4 | GMD61ABDUS4 | USB ultrasound probe, general purpose/abdominal | ClearProbe | GLOBALMEDIA GROUP, LLC |
26 | B377GMD61ABDUS40 | Abdominal V4 | GMD61ABDUS4 | USB ultrasound probe, general purpose/abdominal | ClearProbe | GLOBALMEDIA GROUP, LLC |
27 | B377GMD6180NV010 | Neonatal | GMD6180NV01 | USB ultrasound probe, general purpose/neonatal | ClearProbe | GLOBALMEDIA GROUP, LLC |
28 | B377GMD6180NV010 | Neonatal | GMD6180NV01 | USB ultrasound probe, general purpose/neonatal | ClearProbe | GLOBALMEDIA GROUP, LLC |
29 | B377GMD6175VA010 | Vascular | GMD6175VA01 | USB ultrasound probe, general purpose/vascular | ClearProbe | GLOBALMEDIA GROUP, LLC |
30 | B377GMD6175VA010 | Vascular | GMD6175VA01 | USB ultrasound probe, general purpose/vascular | ClearProbe | GLOBALMEDIA GROUP, LLC |
31 | B377GMD6175RV010 | Endocavity | GMD6175RV01 | USB ultrasound probe, general purpose/endocavity | ClearProbe | GLOBALMEDIA GROUP, LLC |
32 | B377GMD6175RV010 | Endocavity | GMD6175RV01 | USB ultrasound probe, general purpose/endocavity | ClearProbe | GLOBALMEDIA GROUP, LLC |
33 | B377GMD6150AB010 | Abdominal 5 MHz | GMD6150AB01 | USB ultrasound probe, general use/abdominal | ClearProbe | GLOBALMEDIA GROUP, LLC |
34 | B377GMD6150AB010 | Abdominal 5 MHz | GMD6150AB01 | USB ultrasound probe, general use/abdominal | ClearProbe | GLOBALMEDIA GROUP, LLC |
35 | B377GMD6135AB020 | Abdominal 3 MHz | GMD6135AB02 | USB ultrasound probe, general purpose/abdominal | ClearProbe | GLOBALMEDIA GROUP, LLC |
36 | B377GMD6135AB020 | Abdominal 3 MHz | GMD6135AB02 | USB ultrasound probe, general purpose/abdominal | ClearProbe | GLOBALMEDIA GROUP, LLC |
37 | B377GMD6135AB010 | Abdominal 3.5-5 MHz | GMD6135AB01 | USB ultrasound probe, general purpose/abdominal | ClearProbe | GLOBALMEDIA GROUP, LLC |
38 | B377GMD6135AB010 | Abdominal 3.5-5 MHz | GMD6135AB01 | USB ultrasound probe, general purpose/abdominal | ClearProbe | GLOBALMEDIA GROUP, LLC |
39 | B377GMD6112EY01 | Ophthalmic | GMD6112EY01 | USB ultrasound probe, general purpose/ophthalmic | ClearProbe | GLOBALMEDIA GROUP, LLC |
40 | B377GMD6112EY01 | Ophthalmic | GMD6112EY01 | USB ultrasound probe, general purpose/ophthalmic | ClearProbe | GLOBALMEDIA GROUP, LLC |
41 | B371P1002 | 1 | The Perineologic PrecisionPoint™ Transperineal Access System is a sterile, singl The Perineologic PrecisionPoint™ Transperineal Access System is a sterile, single use, disposable, needle guide consisting, of aCarriage and a Rail Clamp Assembly and Access Needle, that is intended for use with a cylindrical style trans-rectal ultrasoundtransducer (0.7” to .85” diameter BK #8658 or equivalent) associated with a BK ProFocus ultrasound system and a biopsy needle.The PrecisionPoint™ Transperineal Access System is designed to stabilize a Perineologic Access Needle on the anatomy as ameans to properly guide the anatomical placement of a biopsy needle into the prostate or other soft tissues through the use ofultrasound-assisted guidance. | Perineologic | CORBIN CLINICAL RESOURCES, LLC | |
42 | B371P1001 | 1 | The Perineologic PrecisionPoint™ Transperineal Access System is a sterile, singl The Perineologic PrecisionPoint™ Transperineal Access System is a sterile, single use, disposable, needle guide consisting, of a Carriage and a Rail Clamp Assembly and Access Needle, that is intended for use with a cylindrical style trans-rectal ultrasound transducer (0.7” to .85” diameter BK #8658 or equivalent) associated with a BK ProFocus ultrasound system and a biopsy needle. The PrecisionPoint™ Transperineal Access System is designed to stabilize a Perineologic Access Needle on the anatomy as a means to properly guide the anatomical placement of a biopsy needle into the prostate or other soft tissues through the use of ultrasound-assisted guidance. | Perineologic | CORBIN CLINICAL RESOURCES, LLC | |
43 | B369MUS05185 | P3-A | MUS05185 | Medisono | MEDISONO, LLC | |
44 | B369MUS05184 | MC3-A | MUS05184 | Medisono | MEDISONO, LLC | |
45 | B369MUS05183 | R7-A | MUS05183 | Medisono | MEDISONO, LLC | |
46 | B369MUS05182 | V6-A | MUS05182 | Medisono | MEDISONO, LLC | |
47 | B369MUS05181 | L7S-A | MUS05181 | Medisono | MEDISONO, LLC | |
48 | B369MUS05179 | MC6-A | MUS05179 | Medisono | MEDISONO, LLC | |
49 | B369MUS05178 | L7M-A | MUS05178 | Medisono | MEDISONO, LLC | |
50 | B369MUS05177 | C3-A | MUS05177 | Medisono | MEDISONO, LLC |