No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 09353278000250 | P006105 | Kosmos Binaural Headset, ECG Patient Cable, Bridge Stand | DQD,DPS | Stethoscope, Electronic,Electrocardiograph | 2 | Kosmos Accessories - International | |
2 | 09353278000229 | P006200 | Radiological imaging system transport kit | IYO,IYN | System, Imaging, Pulsed Echo, Ultrasonic,System, Imaging, Pulsed Doppler, Ultrasonic | 2 | AI Station 2 | |
3 | 09353278000588 | P006576 | Ultrasound imaging system application software | IYO,IYN | System, Imaging, Pulsed Echo, Ultrasonic,System, Imaging, Pulsed Doppler, Ultrasonic | 2 | Kosmos OTS | |
4 | 09353278000519 | P006709 | Ultrasound imaging transducer, hand-held | ITX | Transducer, Ultrasonic, Diagnostic | 2 | Kosmos Lexsa | |
5 | 09353278000458 | R006030 | IYO,IYN,DQD,DPS | System, Imaging, Pulsed Echo, Ultrasonic,System, Imaging, Pulsed Doppler, Ultras System, Imaging, Pulsed Echo, Ultrasonic,System, Imaging, Pulsed Doppler, Ultrasonic,Stethoscope, Electronic,Electrocardiograph | 2 | Kosmos Bridge - Refurbished | ||
6 | 09369999064099 | P003994 | Extracorporeal ultrasound imaging system transducer, hand-held | ITX | Transducer, Ultrasonic, Diagnostic | 2 | Uscan Sector Probe (Japan) | |
7 | 09353278000694 | P007465 | Kosmos on Android software application for ultrasound imaging | IYO,IYN | System, Imaging, Pulsed Echo, Ultrasonic,System, Imaging, Pulsed Doppler, Ultrasonic | 2 | Kosmos OTS Android Linear Color | |
8 | 09353278000168 | R005195 | General ultrasound imaging system, battery-powered | IYO | System, Imaging, Pulsed Echo, Ultrasonic | 2 | EchoNous System - Refurbished | |
9 | 09353278000212 | P006115 | Electronic stethoscope | DQD | Stethoscope, Electronic | 2 | Kosmos Binaural Headset | |
10 | 09353278000571 | R006632 | Ultrasound imaging transducer, hand-held | ITX | Transducer, Ultrasonic, Diagnostic | 2 | Kosmos Torso-One - USB | |
11 | 09353278000540 | R006705 | General ultrasound imaging system, battery-powered | IYO | System, Imaging, Pulsed Echo, Ultrasonic | 2 | EchoNous System (Refurbished) | |
12 | 09353278000526 | R006210 | General ultrasound imaging system, battery-powered | IYO | System, Imaging, Pulsed Echo, Ultrasonic | 2 | EchoNous System (Refurbished) | |
13 | 09353278000502 | P006632 | ITX | Transducer, Ultrasonic, Diagnostic | 2 | Kosmos Torso-One - USB | ||
14 | 09353278000038 | P005195 | General ultrasound imaging system, battery-powered | IYO | System, Imaging, Pulsed Echo, Ultrasonic | 2 | Uscan System | |
15 | 09353278000403 | R003994 | Extracorporeal ultrasound imaging system transducer, hand-held | ITX | Transducer, Ultrasonic, Diagnostic | 2 | Uscan Sector Probe - Refurbished (Japan) | |
16 | 09353278000441 | R006025 | ITX,DQD | Transducer, Ultrasonic, Diagnostic,Stethoscope, Electronic | 2 | Kosmos Torso - Refurbished | ||
17 | 09353278000687 | P007213 | Kosmos on Android software application for ultrasound imaging | IYO,IYN | System, Imaging, Pulsed Echo, Ultrasonic,System, Imaging, Pulsed Doppler, Ultrasonic | 2 | Kosmos OTS Android Linear | |
18 | 09353278000007 | P003965 | General ultrasound imaging system, battery-powered | IYO | System, Imaging, Pulsed Echo, Ultrasonic | 2 | Uscan System | |
19 | 09353278000243 | P006186 | Electrocardiograph, professional, single-channelElectrocardiographic lead set, reusable | DPS | Electrocardiograph | 2 | Kosmos ECG Patient Cable - International | |
20 | 09353278000137 | P006025 | Extracorporeal ultrasound imaging system transducer, hand-heldElectronic stethoscope | ITX,DQD | Transducer, Ultrasonic, Diagnostic,Stethoscope, Electronic | 2 | Kosmos Torso | |
21 | 09353278000595 | P006966 | Ultrasound imaging system multi-transducer connection unit | IYN | System, Imaging, Pulsed Doppler, Ultrasonic | 2 | Kosmos Hub | |
22 | 09353278000489 | R006115 | DQD | Stethoscope, Electronic | 2 | Binaural Headset - Refurbished | ||
23 | 09353278000465 | R006208 | Kosmos Binaural Headset, ECG Patient Cable, Bridge Stand | DQD,DPS | Stethoscope, Electronic,Electrocardiograph | 2 | Kosmos Accessories - US - Refurbished | |
24 | 09353278000618 | R006966 | Ultrasound imaging system multi-transducer connection unit | IYN | System, Imaging, Pulsed Doppler, Ultrasonic | 2 | Kosmos Hub (Refurbished) | |
25 | 09353278000267 | P006208 | Kosmos Binaural Headset, ECG Patient Cable, Bridge Stand | DQD,DPS | Stethoscope, Electronic,Electrocardiograph | 2 | Kosmos Accessories - US | |
26 | 09353278000236 | P006210 | General ultrasound imaging system, battery-powered | IYO | System, Imaging, Pulsed Echo, Ultrasonic | 2 | EchoNous System | |
27 | 09353278000533 | P006705 | General ultrasound imaging system, battery-powered | IYO | System, Imaging, Pulsed Echo, Ultrasonic | 2 | EchoNous System | |
28 | 09353278000021 | P005194 | Extracorporeal ultrasound imaging system transducer, hand-held | ITX | Transducer, Ultrasonic, Diagnostic | 2 | Uscan Linear Probe | |
29 | 09353278000014 | R003951 | Extracorporeal ultrasound imaging system transducer, hand-held | ITX | Transducer, Ultrasonic, Diagnostic | 2 | Uscan Sector Probe - Refurbished | |
30 | 09353278000182 | R004104 | General ultrasound imaging system, battery-powered | IYO | System, Imaging, Pulsed Echo, Ultrasonic | 2 | Uscan System - Refurbished (Japan) | |
31 | 09353278000175 | R005600 | Extracorporeal ultrasound imaging system transducer, hand-held | ITX | Transducer, Ultrasonic, Diagnostic | 2 | EchoNous Bladder Probe - Refurbished | |
32 | 09353278000151 | R003965 | General ultrasound imaging system, battery-powered | IYO | System, Imaging, Pulsed Echo, Ultrasonic | 2 | Uscan System - Refurbished | |
33 | 09369999064082 | P003951 | Extracorporeal ultrasound imaging system transducer, hand-held | ITX | Transducer, Ultrasonic, Diagnostic | 2 | Uscan Sector Probe | |
34 | 09353278000410 | P006440 | ITX | Transducer, Ultrasonic, Diagnostic | 2 | Kosmos Torso-One | ||
35 | 09353278000656 | P006598 | LMD | System, Digital Image Communications, Radiological | 1 | Kosmos UP | ||
36 | 09353278000625 | R006709 | Ultrasound imaging transducer, hand-held | ITX | Transducer, Ultrasonic, Diagnostic | 2 | Kosmos Lexsa (Refurbished) | |
37 | 09353278000601 | R005194 | Extracorporeal ultrasound imaging system transducer, hand-held | ITX | Transducer, Ultrasonic, Diagnostic | 2 | Uscan Linear Probe | |
38 | 09353278000120 | P006030 | Diagnostic ultrasound system with integrated electronic stethoscope and electroc Diagnostic ultrasound system with integrated electronic stethoscope and electrocardiographUltrasound/ electrocardiograph/ stethoscope unit | IYO,IYN,DQD,DPS | System, Imaging, Pulsed Echo, Ultrasonic,System, Imaging, Pulsed Doppler, Ultras System, Imaging, Pulsed Echo, Ultrasonic,System, Imaging, Pulsed Doppler, Ultrasonic,Stethoscope, Electronic,Electrocardiograph | 2 | Kosmos Bridge | |
39 | 09353278000113 | P005600 | Extracorporeal ultrasound imaging system transducer, hand-held | ITX | Transducer, Ultrasonic, Diagnostic | 2 | EchoNous Bladder Probe | |
40 | 09353278000076 | P005425 | Radiological imaging system transport kit | IYO | System, Imaging, Pulsed Echo, Ultrasonic | 2 | Uscan Mobile Stand | |
41 | 09353278000205 | P006024 | Radiological imaging system transport kit | IYO | System, Imaging, Pulsed Echo, Ultrasonic | 2 | Uscan Mobile Stand | |
42 | 09353278000144 | P005779 | Electrocardiograph, professional, single-channelElectrocardiographic lead set, reusable | DPS | Electrocardiograph | 2 | Kosmos ECG Patient Cable - US | |
43 | 09353278000069 | P005324 | An electronic unit that supports switching between multiple transducers, and cha An electronic unit that supports switching between multiple transducers, and charging of the display tablet and transducers. | IYO | System, Imaging, Pulsed Echo, Ultrasonic | 2 | Hub | |
44 | 09353278000434 | R006440 | ITX | Transducer, Ultrasonic, Diagnostic | 2 | Kosmos Torso-One - Refurbished | ||
45 | 09353278000199 | R005324 | An electronic unit that supports switching between multiple transducers, and cha An electronic unit that supports switching between multiple transducers, and charging of the display tablet and transducers. | IYO | System, Imaging, Pulsed Echo, Ultrasonic | 2 | Hub - Refurbished | |
46 | 09353278000052 | P005149 | Radiological imaging system transport kit | IYO | System, Imaging, Pulsed Echo, Ultrasonic | 2 | Mobile Stand |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | B616UVXS0 | XS | General Purpose Diagnostic Medical Ultrasonic Imaging System | UltraVision | ULTRAVISION CORPORATION | |
2 | B616UVXR0 | XR | General Purpose Diagnostic Medical Ultrasonic Imaging System | UltraVision | ULTRAVISION CORPORATION | |
3 | B616UVXP0 | XP | General Purpose Diagnostic Medical Ultrasonic Imaging System | UltraVision | ULTRAVISION CORPORATION | |
4 | B510DUS70000 | DUS-7000 | ADVANCED ULTRASOUND | ADVANCED INSTRUMENTATIONS, INC. | ||
5 | B510DUS5000A1 | DUS-5000 | ADVANCED ULTRASOUND | ADVANCED INSTRUMENTATIONS, INC. | ||
6 | B510DUS30001 | DUS-3000 | ADVANCED ULTRASOUND | ADVANCED INSTRUMENTATIONS, INC. | ||
7 | B377GMD61VASUS40 | Vascular V4 | GMD61VASUS4 | USB ultrasound probe, general purpose/vascular | ClearProbe | GLOBALMEDIA GROUP, LLC |
8 | B377GMD61ENDUS40 | Endocavity V4 | GMD61ENDUS4 | USB ultrasound probe, general purpose/endocavity. | ClearProbe | GLOBALMEDIA GROUP, LLC |
9 | B377GMD61ABDUS40 | Abdominal V4 | GMD61ABDUS4 | USB ultrasound probe, general purpose/abdominal | ClearProbe | GLOBALMEDIA GROUP, LLC |
10 | B377GMD6180NV010 | Neonatal | GMD6180NV01 | USB ultrasound probe, general purpose/neonatal | ClearProbe | GLOBALMEDIA GROUP, LLC |
11 | B377GMD6175VA010 | Vascular | GMD6175VA01 | USB ultrasound probe, general purpose/vascular | ClearProbe | GLOBALMEDIA GROUP, LLC |
12 | B377GMD6175RV010 | Endocavity | GMD6175RV01 | USB ultrasound probe, general purpose/endocavity | ClearProbe | GLOBALMEDIA GROUP, LLC |
13 | B377GMD6150AB010 | Abdominal 5 MHz | GMD6150AB01 | USB ultrasound probe, general use/abdominal | ClearProbe | GLOBALMEDIA GROUP, LLC |
14 | B377GMD6135AB020 | Abdominal 3 MHz | GMD6135AB02 | USB ultrasound probe, general purpose/abdominal | ClearProbe | GLOBALMEDIA GROUP, LLC |
15 | B377GMD6135AB010 | Abdominal 3.5-5 MHz | GMD6135AB01 | USB ultrasound probe, general purpose/abdominal | ClearProbe | GLOBALMEDIA GROUP, LLC |
16 | B377GMD6112EY01 | Ophthalmic | GMD6112EY01 | USB ultrasound probe, general purpose/ophthalmic | ClearProbe | GLOBALMEDIA GROUP, LLC |
17 | B3015017750001 | Model 201 | 501775000 | SonoCiné Image Acquisition Station Model 201, PN 501775000 is an accessory to ul SonoCiné Image Acquisition Station Model 201, PN 501775000 is an accessory to ultrasound imaging Systems facilitating their use as an adjunct to mammography for B-mode ultrasonic screening imaging of the breast when used with a linear array transducer consisting of the following components: Image Acquisition Station Model 201 – PN 501775-000, Image Acquisition Station Software Application V3.1.x, PN 501642, Reading Station Software Application, V3.1.x, PN 501973. | SonoCine Image Acquisition Station | SONOCINE, INC. |
18 | B201CGONE0 | CGONE | Clear Guide ONE | CLEAR GUIDE MEDICAL, INC. | ||
19 | B201CGOHM0 | CGOHM | CG-OH-M | The device is intended as an accessory hardware to provide input into medical de The device is intended as an accessory hardware to provide input into medical device software by capturing video and other sensory information from the operational field for purposes of future processing. The device facilitates rigid, needle-like surgical instrument tracking and guidance feedback for diagnostic and interventional procedures in a clinical setting. | Clear Guide Optical Head | CLEAR GUIDE MEDICAL, INC. |
20 | B201CGOH0 | CGOH | CG-OH | The device is intended as an accessory hardware to provide input into medical de The device is intended as an accessory hardware to provide input into medical device software by capturing video and other sensory information from the operational field for purposes of future processing. The device facilitates rigid, needle-like surgical instrument tracking and guidance feedback for diagnostic and interventional procedures in a clinical setting. | Clear Guide Optical Head | CLEAR GUIDE MEDICAL, INC. |
21 | B201CGCORE170 | CGCORE17 | CG-CORE17 | The device is intended as a computer platform to perform computation, display, c The device is intended as a computer platform to perform computation, display, connectivity and user input functions for CLEAR GUIDE image guidance software (e.g., Clear Guide SCENERGY). The device facilitates rigid, needle-like surgical instrument tracking and guidance feedback for diagnostic and interventional procedures in a clinical setting. The CG-CORE17 model is a panel PC with a 17" screen. | Clear Guide CORE | CLEAR GUIDE MEDICAL, INC. |
22 | B118314170 | Classic | Sonocubic 3D Ultrasound Software is a software intended to acquire, retrieve, an Sonocubic 3D Ultrasound Software is a software intended to acquire, retrieve, analyze and store ultrasound images for computerized three-dimensional image processing, from raw 2D ultrasound series. | Sonocubic 3D Ultrasound Software | MEDGE PLATFORMS INC | |
23 | B118314160 | Classic | Sonocubic 3D Ultrasound Software is a software intended to acquire, retrieve, an Sonocubic 3D Ultrasound Software is a software intended to acquire, retrieve, analyze and store ultrasound images for computerized three-dimensional image processing, from raw 2D ultrasound series. | Sonocubic 3D Ultrasound Software | MEDGE PLATFORMS INC | |
24 | B017ED102 | EyeSeal Disposable | ED1 | ArcScan Insight 100 | ARCSCAN, INC. | |
25 | B017AS100 | AS100 | AS100-120 | ArcScan Insight 100 | ARCSCAN, INC. | |
26 | B015000010 | 00001 | Accuro | RIVANNA MEDICAL, LLC | ||
27 | 90814277020127 | 21-05012-01 | Sterile Transducer Cover - individual cover in envelope | Sonic Window Sterile Transducer Cover | ANALOGIC CORPORATION | |
28 | 90814277020028 | 10-73868-02 | Replacement unit for Sonic Window Handheld Ultrasound System | Sonic Window Handheld Ultrasound Unit | ANALOGIC CORPORATION | |
29 | 90814277020011 | 10-73869-01 | Docking Station for Sonic Window Handheld Ultrasound System | Sonic Window Docking Station | ANALOGIC CORPORATION | |
30 | 90814277020004 | 10-73690-02 | The Sonic Window is intended for the visualization of vessels and vascular acces The Sonic Window is intended for the visualization of vessels and vascular access guidance of needles and catheters (Insertion of Peripheral Intra Venous (PIV) Catheters, as an example). The Sonic Window is not indicated for use by a layperson and shall be used by prescription only. | Sonic Window Handheld Ultrasound System | ANALOGIC CORPORATION | |
31 | 60889971738837 | Touch Prime Ultrasound System | 1738830 | XE Edition | Touch Prime Ultrasound System | CARESTREAM HEALTH, INC. |
32 | 60889971738820 | Touch Prime Ultrasound System | 1738822 | Touch Prime Ultrasound System | Touch Prime Ultrasound System | CARESTREAM HEALTH, INC. |
33 | 58051887042642 | THD HRStation | 800299 | THD HRStation is an integrated proctological station mainly dedicated to the dia THD HRStation is an integrated proctological station mainly dedicated to the diagnosis of pathologies of the anal canal and specifically to the diagnosis of precancerous lesions.Thanks to the THD Procto Software, it allows the proctologist to have a unique, modular and expandable diagnostic system that, in addition to the realization of high resolution anoscopy, can also allow further diagnostic investigations such as anorectal manometry and Transanal ultrasound. | THD Procto Software System | THD SPA |
34 | 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 | ACIST HDi® HD IVUS System | ACIST MEDICAL SYSTEMS, INC. | |
35 | 30856724004357 | 06-050-030 | Clear Image Singles Lite | NEXT MEDICAL PRODUCTS, LLC | ||
36 | 30856724004340 | 17903 | Ultrasound Gel, High Viscosity | ClearWave | NEXT MEDICAL PRODUCTS, LLC | |
37 | 30856724004333 | 17000 | Ultrasound Gel, Medium Viscosity | ClearWave | NEXT MEDICAL PRODUCTS, LLC | |
38 | 30856724004326 | 02-050-030 | Clear Image Singles | NEXT MEDICAL PRODUCTS, LLC | ||
39 | 30856724004203 | 05-812 | Clear Image Ultrasound Gel, Medium Viscosity, 8 oz. | Clear Image | NEXT MEDICAL PRODUCTS, LLC | |
40 | 30856724004197 | 02-812 | Clear Image Ultrasound Gel, High Viscosity, 8 oz. bottle | Clear Image | NEXT MEDICAL PRODUCTS, LLC | |
41 | 30856724004166 | 04-048-020 | Clear Image Sterile Ultrasound Gel, 20ml | Clear Image Singles Sterile | NEXT MEDICAL PRODUCTS, LLC | |
42 | 30856724004159 | 11-405 | LithoClear | NEXT MEDICAL PRODUCTS, LLC | ||
43 | 30856724004142 | 11-601 | LithoClear | NEXT MEDICAL PRODUCTS, LLC | ||
44 | 30856724004135 | 06-400-030 | Clear Image Singles Lite | NEXT MEDICAL PRODUCTS, LLC | ||
45 | 30856724004128 | 06-400B-030 | Clear Image Singles Lite | NEXT MEDICAL PRODUCTS, LLC | ||
46 | 30856724004104 | 02-400-015 | Clear Image Singles, High Viscosity, 15ml | Clear Image Singles | NEXT MEDICAL PRODUCTS, LLC | |
47 | 30856724004098 | 02-400B-015 | Clear Image Singles, High Viscosity, 15ml | Clear Image Singles | NEXT MEDICAL PRODUCTS, LLC | |
48 | 30856724004074 | 02-400-030 | Clear Image Singles, High Viscosity | Clear Image Singles | NEXT MEDICAL PRODUCTS, LLC | |
49 | 30856724004067 | 02-400B-030 | Clear Image Singles, High Viscosity | Clear Image Singles | NEXT MEDICAL PRODUCTS, LLC | |
50 | 30856724004043 | 05-405 | Clear Image Ultrasound Gel, Medium Viscosity, 5L | Clear Image | NEXT MEDICAL PRODUCTS, LLC |