No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 06944904099781 | DC-25 | IYN | System, Imaging, Pulsed Doppler, Ultrasonic | 2 | DC-25 | ||
2 | 06944904097954 | 115-049881-00 | IYN | System, Imaging, Pulsed Doppler, Ultrasonic | 2 | L11-3U Sensor Holder Package | ||
3 | 06944904099088 | DC-80 PRO | IYN | System, Imaging, Pulsed Doppler, Ultrasonic | 2 | DC-80 PRO | ||
4 | 06944904099064 | 115-051014-00 | IYN | System, Imaging, Pulsed Doppler, Ultrasonic | 2 | UltraView Disk | ||
5 | 06944904098630 | 115-050194-00 | IYN | System, Imaging, Pulsed Doppler, Ultrasonic | 2 | USB three-button foot switch Kit | ||
6 | 06944904098500 | 115-044872-00 | KOI | Stimulator, Nerve, Peripheral, Electric | 2 | NMT Module (Package/no accessory) | ||
7 | 06944904089898 | 115-030623-00 | IYN | System, imaging, pulsed doppler, ultrasonic | 2 | Wireless Footswitch | ||
8 | 06944904090061 | 115-042844-00 | IYN | System, imaging, pulsed doppler, ultrasonic | 2 | pen probe cable package | ||
9 | 06944904098487 | 120-005596-00 | OIJ | Biopsy Needle Guide Kit | 2 | NGB-035 Needle-guided Bracket | ||
10 | 06944904086903 | 115-022518-00 | JGS | ELECTRODE, ION SPECIFIC, SODIUM | 2 | Drainage Unit | ||
11 | 06944904063171 | 115-030430-00 | IYN | System, imaging, pulsed doppler, ultrasonic | 2 | BNC head ECG Lead(FDA ) | ||
12 | 06944904018676 | BS-200 | JGS | ELECTRODE, ION SPECIFIC, SODIUM | 2 | Auto Chemistry Analyzer BS-200 | ||
13 | 06944904089980 | 115-006988-00 | IYN | System, imaging, pulsed doppler, ultrasonic | 2 | Trolley VCR-wire Package | ||
14 | 06944904098654 | 115-050190-00 | IYN | System, Imaging, Pulsed Doppler, Ultrasonic | 2 | 3-Lead,ECG,Univ,Pinch,36",AAMI Kit | ||
15 | 06944904098647 | 115-050191-00 | IYN | System, Imaging, Pulsed Doppler, Ultrasonic | 2 | DC-IN CABLE(MIC)Kit | ||
16 | 06944904097947 | 120-005524-00 | IYN | System, Imaging, Pulsed Doppler, Ultrasonic | 2 | UMT-500Plus Mobile Cart | ||
17 | 06944904099071 | DC-80 EXP | IYN | System, Imaging, Pulsed Doppler, Ultrasonic | 2 | DC-80 EXP | ||
18 | 06944904098531 | 115-050198-00 | IYN | System, Imaging, Pulsed Doppler, Ultrasonic | 2 | Wheeled Boarding Bag | ||
19 | 06944904098104 | 115-044346-00 | IYN | System, Imaging, Pulsed Doppler, Ultrasonic | 2 | 4D Module Kit | ||
20 | 06944904097992 | 040-003528-00 | DRW | Adaptor, Lead Switching, Electrocardiograph | 2 | 12Pin 12-Lead Host Cable | ||
21 | 06944904096773 | 115-046900-00 | DXG | Computer, Diagnostic, Pre-Programmed, Single-Function | 2 | ScvO2 function upgrade kit | ||
22 | 06944904089706 | 115-010085-00 | IYN | System, imaging, pulsed doppler, ultrasonic | Rechargeable Li-ion Battery Pack | |||
23 | 06944904098470 | 115-050570-00 | MHX | Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | 2 | IBP_CO_AG Module(with 02)(FDA)II | ||
24 | 06944904098371 | 115-051375-00 | MSX | System, Network And Communication, Physiological Monitors | 2 | 0155 Signal Converter Pack(LED Adapter) | ||
25 | 06944904098326 | M6 Exp | IYN | System, Imaging, Pulsed Doppler, Ultrasonic | 2 | M6 Exp | ||
26 | 06944904097138 | Z108-08 | ITX | Transducer, Ultrasonic, Diagnostic | 2 | P4-1c Phased Array Tranducer 84004-30 | ||
27 | 06944904097107 | 120-005534-00 | ITX | Transducer, Ultrasonic, Diagnostic | 2 | L20-5s Ultrasonic Probe(SMS) | ||
28 | 06944904096759 | 115-046928-00 | CCJ | Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase | 2 | ORIDION CO2(Package/no accessory) | ||
29 | 06944904092973 | 115-046285-00 | IYN | System, Imaging, Pulsed Doppler, Ultrasonic | 2 | Konica Table Mount | ||
30 | 06944904092942 | 120-004749-00 | ITX | Transducer, Ultrasonic, Diagnostic | 2 | 7L4s Ultrasonic Probe Konica(FDA) | ||
31 | 06944904092829 | 120-004652-00 | ITX | Transducer, Ultrasonic, Diagnostic | 2 | L16-4HU Ultrasonic Probe(FDA) | ||
32 | 06944904092775 | 120-004613-00 | ITX | Transducer, Ultrasonic, Diagnostic | 2 | P10-4U Ultrasonic Probe(FDA) | ||
33 | 06944904092690 | z.one pro | IYN | System, Imaging, Pulsed Doppler, Ultrasonic | 2 | z.one pro Diagnostic Ultrasound System | ||
34 | 06944904092614 | Z125-00 | ITX | Transducer, Ultrasonic, Diagnostic | 2 | L20-5 Linear Array Tranducer 87222-00 | ||
35 | 06944904092553 | Z108-30 | ITX | Transducer, Ultrasonic, Diagnostic | 2 | P4-1c Phased Array Tranducer 84004-30 | ||
36 | 06944904092515 | 120-004576-00 | ITX | Transducer, Ultrasonic, Diagnostic | 2 | P8-3Ts Ultrasonic Probe(FDA) | ||
37 | 06944904091969 | 045-003255-00 | MHX | Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | 2 | N12 roll stands(With iPM/iMEC adapter) | ||
38 | 06944904090603 | 040-002258-00 | KOI | Stimulator, Nerve, Peripheral, Electric | 2 | Bandage for NMT sensor | ||
39 | 06944904089850 | 115-003486-00 | IYN | System, imaging, pulsed doppler, ultrasonic | 2 | IO Extend Module(FDA) | ||
40 | 06944904089621 | 115-023072-00 | IYN | System, imaging, pulsed doppler, ultrasonic | M9 Li-ion battery FRU(FDA) | |||
41 | 06944904089607 | 115-035885-00 | IYN | System, imaging, pulsed doppler, ultrasonic | 2 | ECG Module | ||
42 | 06944904089430 | PR3A-30-90482 | ITX | Transducer, ultrasonic, diagnostic | 2 | XDUCER ENDOCAVITY,65EC10EB,FDA | ||
43 | 06944904089249 | PR1F-30-91138 | ITX | Transducer, ultrasonic, diagnostic | 2 | 3C1 Ultrasonic Transducer(FDA) | ||
44 | 06944904089096 | PL2J-30-90996 | ITX | Transducer, ultrasonic, diagnostic | 2 | 75LT38EA Ultrasonic Transducer(FDA) | ||
45 | 06944904089089 | PL2F-30-90823 | ITX | Transducer, ultrasonic, diagnostic | 2 | 65EL60EA Ultrasonic Transducer(FDA) | ||
46 | 06944904088921 | PL1J-30-90759 | ITX | Transducer, ultrasonic, diagnostic | 2 | 7L4A Ultrasonic Transducer(FDA) | ||
47 | 06944904088488 | 120-003623-00 | ITX | Transducer, ultrasonic, diagnostic | 2 | L10-3s Ultrasonic Probe(FDA) | ||
48 | 06944904088457 | 120-003605-00 | ITX | Transducer, ultrasonic, diagnostic | 2 | DE10-3U Ultrasonic Probe(FDA) | ||
49 | 06944904088280 | 120-003462-00 | ITX | Transducer, ultrasonic, diagnostic | 2 | SC5-1E Ultrasonic Probe(FDA) | ||
50 | 06944904087405 | 120-001112-01 | ITX | Transducer, ultrasonic, diagnostic | 2 | L14-6Ns Ultrasonic Transducer(FDA) |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 00184360000709 | 806302012 | s5i Control Console | VOLCANO CORPORATION | ||
2 | 00184360000686 | 807401001 | s5i Imaging System Workstation | VOLCANO CORPORATION | ||
3 | 00184360000525 | 807301001 | s5 PC Module | VOLCANO CORPORATION | ||
4 | 00083059012071 | 1207 | The Aware™ Pad is intended to be used as an aid for performing breast self-examination. | Aware Breast Self-Exam Pad | BIOMERICA, INC. | |
5 | 00083059012033 | 1203 | The Aware™ Pad is intended to be used as an aid for performing breast self-examination. | Aware Breast Self-Exam Pad | BIOMERICA, INC. | |
6 | 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. | |
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 | B510DUS70000 | DUS-7000 | ADVANCED ULTRASOUND | ADVANCED INSTRUMENTATIONS, INC. | ||
11 | B510DUS5000A1 | DUS-5000 | ADVANCED ULTRASOUND | ADVANCED INSTRUMENTATIONS, INC. | ||
12 | B510DUS30001 | DUS-3000 | ADVANCED ULTRASOUND | ADVANCED INSTRUMENTATIONS, INC. | ||
13 | B377GMD61VASUS40 | Vascular V4 | GMD61VASUS4 | USB ultrasound probe, general purpose/vascular | ClearProbe | GLOBALMEDIA GROUP, LLC |
14 | B377GMD61ENDUS40 | Endocavity V4 | GMD61ENDUS4 | USB ultrasound probe, general purpose/endocavity. | ClearProbe | GLOBALMEDIA GROUP, LLC |
15 | B377GMD61ABDUS40 | Abdominal V4 | GMD61ABDUS4 | USB ultrasound probe, general purpose/abdominal | ClearProbe | GLOBALMEDIA GROUP, LLC |
16 | B377GMD6180NV010 | Neonatal | GMD6180NV01 | USB ultrasound probe, general purpose/neonatal | ClearProbe | GLOBALMEDIA GROUP, LLC |
17 | B377GMD6175VA010 | Vascular | GMD6175VA01 | USB ultrasound probe, general purpose/vascular | ClearProbe | GLOBALMEDIA GROUP, LLC |
18 | B377GMD6175RV010 | Endocavity | GMD6175RV01 | USB ultrasound probe, general purpose/endocavity | ClearProbe | GLOBALMEDIA GROUP, LLC |
19 | B377GMD6150AB010 | Abdominal 5 MHz | GMD6150AB01 | USB ultrasound probe, general use/abdominal | ClearProbe | GLOBALMEDIA GROUP, LLC |
20 | B377GMD6135AB020 | Abdominal 3 MHz | GMD6135AB02 | USB ultrasound probe, general purpose/abdominal | ClearProbe | GLOBALMEDIA GROUP, LLC |
21 | B377GMD6135AB010 | Abdominal 3.5-5 MHz | GMD6135AB01 | USB ultrasound probe, general purpose/abdominal | ClearProbe | GLOBALMEDIA GROUP, LLC |
22 | B377GMD6112EY01 | Ophthalmic | GMD6112EY01 | USB ultrasound probe, general purpose/ophthalmic | ClearProbe | GLOBALMEDIA GROUP, LLC |
23 | 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. |
24 | B201CGONE0 | CGONE | Clear Guide ONE | CLEAR GUIDE MEDICAL, INC. | ||
25 | 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. |
26 | 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. |
27 | 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. |
28 | 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 | |
29 | 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 | |
30 | B017ED102 | EyeSeal Disposable | ED1 | ArcScan Insight 100 | ARCSCAN, INC. | |
31 | B017AS100 | AS100 | AS100-120 | ArcScan Insight 100 | ARCSCAN, INC. | |
32 | B015000010 | 00001 | Accuro | RIVANNA MEDICAL, LLC | ||
33 | 90814277020127 | 21-05012-01 | Sterile Transducer Cover - individual cover in envelope | Sonic Window Sterile Transducer Cover | ANALOGIC CORPORATION | |
34 | 90814277020028 | 10-73868-02 | Replacement unit for Sonic Window Handheld Ultrasound System | Sonic Window Handheld Ultrasound Unit | ANALOGIC CORPORATION | |
35 | 90814277020011 | 10-73869-01 | Docking Station for Sonic Window Handheld Ultrasound System | Sonic Window Docking Station | ANALOGIC CORPORATION | |
36 | 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 | |
37 | 60889971738837 | Touch Prime Ultrasound System | 1738830 | XE Edition | Touch Prime Ultrasound System | CARESTREAM HEALTH, INC. |
38 | 60889971738820 | Touch Prime Ultrasound System | 1738822 | Touch Prime Ultrasound System | Touch Prime Ultrasound System | CARESTREAM HEALTH, INC. |
39 | 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 |
40 | 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. | |
41 | 30856724004357 | 06-050-030 | Clear Image Singles Lite | NEXT MEDICAL PRODUCTS, LLC | ||
42 | 30856724004340 | 17903 | Ultrasound Gel, High Viscosity | ClearWave | NEXT MEDICAL PRODUCTS, LLC | |
43 | 30856724004333 | 17000 | Ultrasound Gel, Medium Viscosity | ClearWave | NEXT MEDICAL PRODUCTS, LLC | |
44 | 30856724004326 | 02-050-030 | Clear Image Singles | NEXT MEDICAL PRODUCTS, LLC | ||
45 | 30856724004203 | 05-812 | Clear Image Ultrasound Gel, Medium Viscosity, 8 oz. | Clear Image | NEXT MEDICAL PRODUCTS, LLC | |
46 | 30856724004197 | 02-812 | Clear Image Ultrasound Gel, High Viscosity, 8 oz. bottle | Clear Image | NEXT MEDICAL PRODUCTS, LLC | |
47 | 30856724004166 | 04-048-020 | Clear Image Sterile Ultrasound Gel, 20ml | Clear Image Singles Sterile | NEXT MEDICAL PRODUCTS, LLC | |
48 | 30856724004159 | 11-405 | LithoClear | NEXT MEDICAL PRODUCTS, LLC | ||
49 | 30856724004142 | 11-601 | LithoClear | NEXT MEDICAL PRODUCTS, LLC | ||
50 | 30856724004135 | 06-400-030 | Clear Image Singles Lite | NEXT MEDICAL PRODUCTS, LLC |