No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 00850681007191 | NA-DSP2 | NA-DSP2 | The NovaKit contains the following single use items; probe pod covers, head crad The NovaKit contains the following single use items; probe pod covers, head cradle comfort padding, head stabilizer comfort padding, and registration dots. | ITX,IYN,OQQ | Transducer, Ultrasonic, Diagnostic,System, Imaging, Pulsed Doppler, Ultrasonic,D Transducer, Ultrasonic, Diagnostic,System, Imaging, Pulsed Doppler, Ultrasonic,Diagnostic Ultrasonic Transducer, Robotic | 2 | NovaKit Exam Pack (NovaKit) |
2 | 00850681007122 | 1.x | NA-RBT1 | The NeuralBot System is a cart mounted, robotic transcranial Doppler (TCD) probe The NeuralBot System is a cart mounted, robotic transcranial Doppler (TCD) probe positioning accessory for the previously cleared Lucid M1 System (K160442) which assists the user in the acquisition of cerebral blood flow velocity (CBFV) and the occurrence of transient emboli within the blood stream, via the patient’s temporal acoustic windows. | IYN,ITX,OQQ | System, Imaging, Pulsed Doppler, Ultrasonic,Transducer, Ultrasonic, Diagnostic,D System, Imaging, Pulsed Doppler, Ultrasonic,Transducer, Ultrasonic, Diagnostic,Diagnostic Ultrasonic Transducer, Robotic | 2 | NeuralBot |
3 | 00850681007023 | 40-00009 | NA - PRB2 | The monitoring transducer is a 2 MHz single-element ultrasound transducer design The monitoring transducer is a 2 MHz single-element ultrasound transducer designed for mounting on a headset to perform velocity measurements.The transducer has the following specifications:• 2MHz ± 0.1MHz center frequency• 46mm ± 5mm focal length• 16mm active diameter• Fractional 6dB pulse-echo bandwidth = 60% to 80%• Round-trip insertion loss < 6dB• Impedance 22 ohm +/- 5 ohms, real 0°+/- 15° phase | ITX | Transducer, Ultrasonic, Diagnostic | 2 | 2-MHz Headset/Monitoring Transducer |
4 | 00850681007221 | NA-LUCM1 | NA-LUCM1 | The Lucid TCD is a medical ultrasound system intended for use as an adjunct to t The Lucid TCD is a medical ultrasound system intended for use as an adjunct to the standard clinical practices for measuring and displaying cerebral blood flow velocity (CBFV) within the major conducting arteries and veins of the head and neck. Additionally, the Lucid TCD measures the occurrence of transient emboli signals within the blood stream.The device is not intended to replace other means of evaluating vital patient physiological processes, is not intended to be used in fetal applications, and is not intended to be used inside the sterile field. | ITX,IYN | Transducer, Ultrasonic, Diagnostic,System, Imaging, Pulsed Doppler, Ultrasonic | 2 | Lucid Transcranial Doppler Ultrasound System (Lucid TCD) |
5 | 00850681007184 | NA-RBT1 | NA-RBT1 | NovaBot Automated Headset accessory for the Lucid TCD. When connected to the Luc NovaBot Automated Headset accessory for the Lucid TCD. When connected to the Lucid TCD, the combined device is referred to as the NovaGuide.The NovaBot is a cart mounted, robotic transcranial Doppler (TCD) probe positioning accessory for the previously cleared Lucid TCD (K160442) which assists the user in the acquisition of cerebral blood flow velocity (CBFV) and the occurrence of transient emboli within the blood stream, via the patient's temporal acoustic windows. | IYN,ITX,OQQ | System, Imaging, Pulsed Doppler, Ultrasonic,Transducer, Ultrasonic, Diagnostic,D System, Imaging, Pulsed Doppler, Ultrasonic,Transducer, Ultrasonic, Diagnostic,Diagnostic Ultrasonic Transducer, Robotic | 2 | NovaBot Automated Headset |
6 | 00850681007177 | NA-DSP3 | NA-DSP3 | Procedural set that includes replacement foam for the monitoring headframe. | ITX | Transducer, Ultrasonic, Diagnostic | 2 | Monitoring Headframe Foam Procedural Set |
7 | 00850681007047 | 10-00002 | NA-ACC2 | The Remote Control Accessory is an optional accessory device designed to replica The Remote Control Accessory is an optional accessory device designed to replicate the touch screen interface for commonly used commands during exams. | ITX | Transducer, Ultrasonic, Diagnostic | 2 | Remote Control Accessory |
8 | 00850681007160 | NA-MOUNT2 | NA-MOUNT2 | ITX | Transducer, Ultrasonic, Diagnostic | 2 | Temporal Monitoring Headframe | |
9 | 00850681007283 | 25-00004 | NSC-NVK | IYN,ITX | System, Imaging, Pulsed Doppler, Ultrasonic,Transducer, Ultrasonic, Diagnostic | 2 | NovaKit™ 2 Exam Pack | |
10 | 00850681007153 | NA-PRB3 | NA-PRB3 | The monitoring transducer is a 2 MHz single-element ultrasound transducer design The monitoring transducer is a 2 MHz single-element ultrasound transducer designed for mounting on a headset to perform velocity measurements.The transducer has the following specifications:• 2MHz ± 0.1MHz center frequency• 46mm ± 5mm focal length• 16mm active diameter• Fractional 6dB pulse-echo bandwidth = 60% to 80%• Round-trip insertion loss < 6dB• Impedance 22 ohm +/- 5 ohms, real 0°+/- 15° phase | ITX | Transducer, Ultrasonic, Diagnostic | 2 | 2Mhz Monitoring Transducer - 8 foot |
11 | 00850681007443 | 05-00019 | NA-RBTSYS1 | IYN,ITX,OQQ | System, Imaging, Pulsed Doppler, Ultrasonic,Transducer, Ultrasonic, Diagnostic,D System, Imaging, Pulsed Doppler, Ultrasonic,Transducer, Ultrasonic, Diagnostic,Diagnostic Ultrasonic Transducer, Robotic | 2 | NovaGuide™ Intelligent Ultrasound System | |
12 | 00850681007115 | 1.x | NA-DSP2 | The NeuralBot procedural set contains the following single use items; probe pod The NeuralBot procedural set contains the following single use items; probe pod covers, head cradle comfort padding, head stabilizer comfort padding, and registration dots. | ITX,OQQ,IYN | Transducer, Ultrasonic, Diagnostic,Diagnostic Ultrasonic Transducer, Robotic,Sys Transducer, Ultrasonic, Diagnostic,Diagnostic Ultrasonic Transducer, Robotic,System, Imaging, Pulsed Doppler, Ultrasonic | 2 | NeuralBot Procedural Set (Single Use) |
13 | 00850681007399 | 05-00030 | NSC-NVGSYS2 | IYN,ITX | System, Imaging, Pulsed Doppler, Ultrasonic,Transducer, Ultrasonic, Diagnostic | 2 | NovaGuide™ 2 Intelligent Ultrasound System | |
14 | 00850681007016 | 40-00008 | NA – PRB1 | The handheld transducer is a 2 MHz single-element ultrasound transducer designed The handheld transducer is a 2 MHz single-element ultrasound transducer designed to be held by hand to perform velocity measurements.The transducer has the following specifications:• 2MHz ± 0.1MHz center frequency• 46mm ± 5mm focal length• 16mm active diameter• Fractional 6dB pulse-echo bandwidth = 60% to 80%• Round-trip insertion loss < 6dB• Impedance 22 ohm +/- 5 ohms, real 0°+/- 15° phase | ITX | Transducer, Ultrasonic, Diagnostic | 2 | 2-MHz Transducer, Handheld |
15 | 00850681007009 | M1 | NA – LUCM1 | ITX,IYN | Transducer, Ultrasonic, Diagnostic,System, Imaging, Pulsed Doppler, Ultrasonic | 2 | Lucid Transcranial Doppler System | |
16 | 00850681007405 | NSC-TCDNG2 | NSC-TCDNG2 | IYN,ITX | System, Imaging, Pulsed Doppler, Ultrasonic,Transducer, Ultrasonic, Diagnostic | 2 | NovaGuide™ 2 Traditional Ultrasound System | |
17 | 00850681007030 | 40-00010 | NA – MOUNT1 | ITX | Transducer, Ultrasonic, Diagnostic | 2 | Temporal Monitoring Headset |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 00857042007999 | 900000 | 900000 | AcQMap System | AcQMap | ACUTUS MEDICAL, INC. |
2 | 00857042007920 | 900100 | 900100 | AcQMap System Console 2.0 | AcQMap | ACUTUS MEDICAL, INC. |
3 | 00857042007876 | 800727 | 800727 | AcQMap to DiamondTemp Generator Adapter | DiamondTemp Generator Adapter | ACUTUS MEDICAL, INC. |
4 | 00857042007562 | 800605 | 800605 | AcQMap Patient Electrode Kit | AcQMap | ACUTUS MEDICAL, INC. |
5 | 00857042007425 | 800604 | 800604 | AcQMap Auxiliary Interface Box, Console 2.0 | AcQMap | ACUTUS MEDICAL, INC. |
6 | 00857042007418 | 800530 | 800530 | AcQMap Catheter Interface Cable | AcQMap | ACUTUS MEDICAL, INC. |
7 | 00857042007401 | 900009 | 900009 | AcQMap 3D Imaging & Mapping Catheter | AcQMap | ACUTUS MEDICAL, INC. |
8 | 00857042007388 | 800531 | 800531 | Cable, AcQMap Surface ECG Output (AHA) Packaged | AcQMap | ACUTUS MEDICAL, INC. |
9 | 00857042007364 | 800405 | 800405 | POAG Cable MC-POAG-EC6/2 | AcQMap | ACUTUS MEDICAL, INC. |
10 | 00857042007357 | 800255 | 800255 | Workstation Cable | AcQMap | ACUTUS MEDICAL, INC. |
11 | 00857042007333 | 800601 | 800601 | Power Cord, Console 2.0 | AcQMap | ACUTUS MEDICAL, INC. |
12 | 00854763006249 | MS-05-0257 | Field generator clamp assembly that connects the Planar Field generator to the h Field generator clamp assembly that connects the Planar Field generator to the hospital bed | Acessa ProVu PFG Table Clamp | ACESSA HEALTH INC. | |
13 | 00854763006232 | 7100 | Acessa ProVu System, Power Cord, Foot Pedal Assembly, Video Cable | Acessa ProVu System | ACESSA HEALTH INC. | |
14 | 00854763006195 | 8100 | Acessa ProVu Planar Field Generator (PFG), connects to the ProVu Console | Acessa ProVu Planar Field Generator (PFG) | ACESSA HEALTH INC. | |
15 | 00854763006157 | 7400 | Acessa ProVu Handpiece Cable, Reusable, Connects to the Acessa ProVu Console | Acessa ProVu Handpiece Cable | ACESSA HEALTH INC. | |
16 | 00854763006140 | 7300 | Disposable Handpiece connects to Acessa ProVu Console | Acessa ProVu Handpiece | ACESSA HEALTH INC. | |
17 | 00854763006126 | 5200 | Acessa Table Top Field Generator (TTFG), connects to the Acessa ProVu Console. I Acessa Table Top Field Generator (TTFG), connects to the Acessa ProVu Console. Includes TTFG Pad Set | Acessa Table Top Field Generator | ACESSA HEALTH INC. | |
18 | 00854763006119 | 4300 | Acessa Pad Cable, Reusable, connects to the Acessa ProVu ConsoleLegacy DI #854763006072 | Acessa Pad Cable | ACESSA HEALTH INC. | |
19 | 00854763006102 | 3000 | Acessa Pads, disposable dispersive pad, connects to the Acessa ProVu ConsoleLega Acessa Pads, disposable dispersive pad, connects to the Acessa ProVu ConsoleLegacy #854763006010 | Acessa Pads | ACESSA HEALTH INC. | |
20 | 00853386006285 | US0000 | LIGHTSonic B UBM | LIGHTMED USA INC | ||
21 | 00852698007508 | uSmart3200T Plus | Terason uSmart3200T PLUS ultrasound system | Terason | TERATECH CORPORATION | |
22 | 00852698007508 | uSmart3200T Plus | Terason uSmart3200T PLUS ultrasound system | Terason | TERATECH CORPORATION | |
23 | 00852698007416 | uSmart3200T | The Terason uSmart3200T Cart is used to provide a portable solution-On-Wheels fo The Terason uSmart3200T Cart is used to provide a portable solution-On-Wheels for the Terason uSmart3200T Ultrasound Imaging System. | Terason | TERATECH CORPORATION | |
24 | 00852698007416 | uSmart3200T | The Terason uSmart3200T Cart is used to provide a portable solution-On-Wheels fo The Terason uSmart3200T Cart is used to provide a portable solution-On-Wheels for the Terason uSmart3200T Ultrasound Imaging System. | Terason | TERATECH CORPORATION | |
25 | 00852698007409 | 8BP4 | The Terason 8BP4 is an endocavity ultrasound transducer. Bi-planar: Curve and Li The Terason 8BP4 is an endocavity ultrasound transducer. Bi-planar: Curve and Linear array with a trans-rectal application. | Terason | TERATECH CORPORATION | |
26 | 00852698007386 | uSmart3200T | Triple Programmable USB Foot Switch with Freeze, Save, Store Functions | Terason | TERATECH CORPORATION | |
27 | 00852698007300 | uSmart3200T | AC/DC Medical Grade Power Adapter with AC Cord | Terason | TERATECH CORPORATION | |
28 | 00852698007218 | uSmart3200T | Terason uSmart3200T R2/Nexgen ultrasound system | Terason | TERATECH CORPORATION | |
29 | 00852698007218 | uSmart3200T | Terason uSmart3200T R2/Nexgen ultrasound system | Terason | TERATECH CORPORATION | |
30 | 00852698007188 | uSmart3200T MUX | The Terason uSmart3200T MUX is an electronic device intended to be used with an The Terason uSmart3200T MUX is an electronic device intended to be used with an ultrasound (US) imaging system to enable the simultaneous connection of multiple hand-held ultrasound transducers so the user can conveniently switch between transducers as required. The unit with multiple transducer ports and is attached to the Terason uSmart3200T Cart. | Terason | TERATECH CORPORATION | |
31 | 00852698007188 | uSmart3200T MUX | The Terason uSmart3200T MUX is an electronic device intended to be used with an The Terason uSmart3200T MUX is an electronic device intended to be used with an ultrasound (US) imaging system to enable the simultaneous connection of multiple hand-held ultrasound transducers so the user can conveniently switch between transducers as required. The unit with multiple transducer ports and is attached to the Terason uSmart3200T Cart. | Terason | TERATECH CORPORATION | |
32 | 00852698007171 | uSmart3300 Roller Bag | The Terason uSmart3300 Roller Bag is a self-contained suitcase on wheels. The Te The Terason uSmart3300 Roller Bag is a self-contained suitcase on wheels. The Terason uSmart3300 and associated transducers neatly fit inside the suitcase for easy transportation. | Terason | TERATECH CORPORATION | |
33 | 00852698007171 | uSmart3300 Roller Bag | The Terason uSmart3300 Roller Bag is a self-contained suitcase on wheels. The Te The Terason uSmart3300 Roller Bag is a self-contained suitcase on wheels. The Terason uSmart3300 and associated transducers neatly fit inside the suitcase for easy transportation. | Terason | TERATECH CORPORATION | |
34 | 00852698007164 | uSmart3200T Roller Bag | The Terason uSmart3200T Roller Bag is a self-contained suitcase on wheels. The T The Terason uSmart3200T Roller Bag is a self-contained suitcase on wheels. The Terason uSmart3200T Tablet and associated transducers neatly fit inside the suitcase for easy transportation. | Terason | TERATECH CORPORATION | |
35 | 00852698007164 | uSmart3200T Roller Bag | The Terason uSmart3200T Roller Bag is a self-contained suitcase on wheels. The T The Terason uSmart3200T Roller Bag is a self-contained suitcase on wheels. The Terason uSmart3200T Tablet and associated transducers neatly fit inside the suitcase for easy transportation. | Terason | TERATECH CORPORATION | |
36 | 00852698007157 | uSmart3200T Cart | The Terason uSmart3200T Cart is used to provide a portable-solution-on-wheels fo The Terason uSmart3200T Cart is used to provide a portable-solution-on-wheels for the Terason uSmart3200T ultrasound imaging system. | Terason | TERATECH CORPORATION | |
37 | 00852698007157 | uSmart3200T Cart | The Terason uSmart3200T Cart is used to provide a portable-solution-on-wheels fo The Terason uSmart3200T Cart is used to provide a portable-solution-on-wheels for the Terason uSmart3200T ultrasound imaging system. | Terason | TERATECH CORPORATION | |
38 | 00852698007140 | 15L4A | The Terason 15L4A is a general-purpose high-frequency linear transducer. The int The Terason 15L4A is a general-purpose high-frequency linear transducer. The intended uses include: ophthalmic, abdominal, pediatric, small organ, musculoskeletal (conventional and superficial), and peripheral vascular ultrasound imaging. | Terason | TERATECH CORPORATION | |
39 | 00852698007133 | uSmart3300 MUX | The Terason uSmart3300 MUX is an electronic device intended to be used with an u The Terason uSmart3300 MUX is an electronic device intended to be used with an ultrasound (US) imaging system to enable the simultaneous connection of multiple hand-held ultrasound transducers so the user can conveniently switch between transducers as required. The unit with multiple transducer ports and is attached to the Terason uSmart3300 Cart. | Terason | TERATECH CORPORATION | |
40 | 00852698007133 | uSmart3300 MUX | The Terason uSmart3300 MUX is an electronic device intended to be used with an u The Terason uSmart3300 MUX is an electronic device intended to be used with an ultrasound (US) imaging system to enable the simultaneous connection of multiple hand-held ultrasound transducers so the user can conveniently switch between transducers as required. The unit with multiple transducer ports and is attached to the Terason uSmart3300 Cart. | Terason | TERATECH CORPORATION | |
41 | 00852698007126 | uSmart3300 Cart | The Terason uSmart3300 Cart is used to provide a portable-solution-on-wheels for The Terason uSmart3300 Cart is used to provide a portable-solution-on-wheels for the Terason uSmart3300 ultrasound imaging system. | Terason | TERATECH CORPORATION | |
42 | 00852698007126 | uSmart3300 Cart | The Terason uSmart3300 Cart is used to provide a portable-solution-on-wheels for The Terason uSmart3300 Cart is used to provide a portable-solution-on-wheels for the Terason uSmart3300 ultrasound imaging system. | Terason | TERATECH CORPORATION | |
43 | 00852698007119 | uSmart3200T | The Terason uSmart3200T is a general purpose Ultrasound System intended for use The Terason uSmart3200T is a general purpose Ultrasound System intended for use by a qualified physician for evaluation by ultrasound imaging or fluid flow analysis of the human body. Specific clinical applications and exam types include: Ophthalmic, Fetal, Abdominal, Intraoperative (Spec. and Neuro.), Pediatrics, Small Organ (Thyroid, Breast, Testes); Neonatal and Adult Cephalic, Trans-rectal, Trans-vaginal, Trans-esophageal (non-cardiac), Musculoskeletal (Conventional and Superficial), Cardiac (Adult & Pediatric), Trans-esophageal (cardiac), and Peripheral Vascular. | Terason | TERATECH CORPORATION | |
44 | 00852698007119 | uSmart3200T | The Terason uSmart3200T is a general purpose Ultrasound System intended for use The Terason uSmart3200T is a general purpose Ultrasound System intended for use by a qualified physician for evaluation by ultrasound imaging or fluid flow analysis of the human body. Specific clinical applications and exam types include: Ophthalmic, Fetal, Abdominal, Intraoperative (Spec. and Neuro.), Pediatrics, Small Organ (Thyroid, Breast, Testes); Neonatal and Adult Cephalic, Trans-rectal, Trans-vaginal, Trans-esophageal (non-cardiac), Musculoskeletal (Conventional and Superficial), Cardiac (Adult & Pediatric), Trans-esophageal (cardiac), and Peripheral Vascular. | Terason | TERATECH CORPORATION | |
45 | 00852698007102 | uSmart3300 | The Teratech Corporation Terason uSmart3300 is a general purpose Ultrasound Syst The Teratech Corporation Terason uSmart3300 is a general purpose Ultrasound System intended for use by a qualified physician for evaluation by ultrasound imaging or fluid flow analysis of the human body. Specific clinical applications and exam types include: Ophthalmic, Fetal, Abdominal, Intraoperative (Spec. and Neuro.), Pediatrics, Small Organ (Thyroid, Breast, Testes); Neonatal and Adult Cephalic, Trans-rectal, Trans-vaginal, Trans-esophageal (non-cardiac), Musculoskeletal (Conventional and Superficial); Cardiac (Adult & Pediatric); Trans-esophageal (cardiac) Peripheral Vascular. | Terason | TERATECH CORPORATION | |
46 | 00852698007102 | uSmart3300 | The Teratech Corporation Terason uSmart3300 is a general purpose Ultrasound Syst The Teratech Corporation Terason uSmart3300 is a general purpose Ultrasound System intended for use by a qualified physician for evaluation by ultrasound imaging or fluid flow analysis of the human body. Specific clinical applications and exam types include: Ophthalmic, Fetal, Abdominal, Intraoperative (Spec. and Neuro.), Pediatrics, Small Organ (Thyroid, Breast, Testes); Neonatal and Adult Cephalic, Trans-rectal, Trans-vaginal, Trans-esophageal (non-cardiac), Musculoskeletal (Conventional and Superficial); Cardiac (Adult & Pediatric); Trans-esophageal (cardiac) Peripheral Vascular. | Terason | TERATECH CORPORATION | |
47 | 00852698007096 | 12L5A | The Terason 12L5A is a general-purpose, high-frequency linear transducer array. The Terason 12L5A is a general-purpose, high-frequency linear transducer array. The intended uses include: ophthalmic, abdominal, pediatric, small organ, musculoskeletal (conventional and superficial) and peripheral vascular ultrasound imaging. | Terason | TERATECH CORPORATION | |
48 | 00852698007089 | PDOF | The Terason PDOF is a general-purpose Doppler transducer. The intended uses incl The Terason PDOF is a general-purpose Doppler transducer. The intended uses include: adult and pediatric cardiac ultrasound Doppler imaging. | Terason | TERATECH CORPORATION | |
49 | 00852698007072 | 16HL7 | The Terason 16HL7 is a hockey-stick, linear array transducer. The intended uses The Terason 16HL7 is a hockey-stick, linear array transducer. The intended uses include: intra-operative (spec.), small organ, musculo-skeletal (conventional and superficial), and peripheral vascular ultrasound imaging. | Terason | TERATECH CORPORATION | |
50 | 00852698007065 | 9MC3 | The Terason 9MC3 is a micro-convex transducer array. The intended uses include: The Terason 9MC3 is a micro-convex transducer array. The intended uses include: fetal, pediatric, small organ, neonatal and adult cephalic, adult and pediatric cardiac, and peripheral vascular ultrasound imaging. | Terason | TERATECH CORPORATION |