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The Precision CRF is a multi-functional general Radiography/ Fluoroscopy (R/F) system and includes
• Footrest
• Hand Grips
Radiation Protection Accessories
• Flexible Radiation Protection Apron
• Front Radiation Protection Apron
Additional Accessories (Optional)
• Monitor Trolley
• Monitor Ceiling Suspension
• Parking Frame for Accessories
• Shoulder Support
• Side bar
• Compression Belt
• Adjustable Lateral Cassette Holder
• Leg Supports
• Infusion Bottle Holder
• Arm Support for Catheterization
• Ankle Clamps
• Overhead Hand Grip
• Adult Headrest
• Mattress
• Rotatable Stool for Footrest
• Pediatric Micturition Set
• Stretch Grip for Wall Stand
• Bar Code Scanner
• Patient Support
• Stitching Ruler
Accessories for the SkyPlate Detector (Optional)
• Mobile Detector Holder
• Detector Holder Patient Bed
• Portable Panel Protector
• Detector Handle
• WPD Bags
• Grids for SkyPlate Detector large
Philips Medical Systems DMC GmbH
706400
In Commercial Distribution
- 00884838110588 ()
- Stationary general-purpose fluoroscopic x-ray system, digital
The ProxiDiagnost N90 is a multi-functional general Radiography/ Fluoroscopy (R/F) system and includes
• Footrest
• Hand Grips
Radiation Protection Accessories
• Flexible Radiation Protection Apron
• Front Radiation Protection Apron
Additional Accessories (Optional)
• Monitor Trolley
• Monitor Ceiling Suspension
• Parking Frame for Accessories
• Shoulder Support
• Side bar
• Compression Belt
• Adjustable Lateral Cassette Holder
• Leg Supports
• Infusion Bottle Holder
• Arm Support for Catheterization
• Ankle Clamps
• Overhead Hand Grip
• Adult Headrest
• Mattress
• Rotatable Stool for Footrest
• Pediatric Micturition Set
• Stretch Grip for Wall Stand
• Bar Code Scanner
• Patient Support
• Stitching Ruler
Accessories for the SkyPlate Detector (Optional)
• Mobile Detector Holder
• Detector Holder Patient Bed
• Portable Panel Protector
• Detector Handle
• WPD Bags
• Grids for SkyPlate Detector large
Philips Medical Systems DMC GmbH
706110
In Commercial Distribution
- 00884838103221 ()
- Stationary general-purpose fluoroscopic x-ray system, digital
The Piccolo® Kidney Check , used with the Piccolo Xpress chemistry analyzer, is intended to be used for the in vitro quantitative determination of creatinine and blood urea nitrogen (BUN) in heparinized whole blood, heparinized plasma, or serum in a clinical laboratory setting or point-of-care location.
The tests on this panel are waived under CLIA ’88 regulations. If a laboratory modifies the test system instructions, then the tests are considered high complexity and subject to all CLIA requirements. For CLIA waived labs, only lithium heparin whole blood may be tested. For use in moderate complexity labs, lithium heparinized whole blood, lithium heparinized plasma, or serum may be used.
ABAXIS, INC.
400-0033
In Commercial Distribution
- EABA40000331 ()
- EABA40000330 ()
400-0033
- Urea IVD, reagent
- Creatinine IVD, reagent
The IOPS (Intra-Operative Positioning System) is intended for the evaluation of vascular anatomy as captured using 3D modeling from previously acquired scan data. It is intended for real-time tip positioning and navigation using sensor-equipped, compatible catheters and guidewires used in endovascular interventions in the descending aorta. After the patient is placed on the OR table, a cone beam CT (CBCT) is acquired using fluoroscopy with a flat panel detector (FPD). The scan is uploaded to the hospital’s PACS. The CBCT is registered to the initial CT using the IOPS software and the 3D renderings. The system is indicated for use as an adjunct to fluoroscopy. The IOPS does not make a diagnosis.
Centerline Biomedical, Inc.
SW-1
In Commercial Distribution
- 00843152104000 ()
SW-1
- Electromagnetic surgical navigation device tracking system
The IOPS (Intra-Operative Positioning System) is intended for the evaluation of vascular anatomy as captured using 3D modeling from previously acquired scan data. It is intended for real-time tip positioning and navigation using sensor-equipped, compatible catheters and guidewires used in endovascular interventions in the descending aorta. After the patient is placed on the OR table, a cone beam CT (CBCT) is acquired using fluoroscopy with a flat panel detector (FPD). The scan is uploaded to the hospital’s PACS. The CBCT is registered to the initial CT using the IOPS software and the 3D renderings. The system is indicated for use as an adjunct to fluoroscopy. The IOPS does not make a diagnosis.
Centerline Biomedical, Inc.
MC-1
In Commercial Distribution
- 00843152100002 ()
MC-1
- Electromagnetic surgical navigation device tracking system
MOCACuff (HL168KF) uses the oscillometric method to automatically measure systolic and diastolic blood pressure as well as heart rate. The measurement position is at human being’s wrist. All values can be read out in one LD panel. The device is designed for home use and recommended for use by adults aged 18 years and older with wrist circumference ranging approx. 5.3~7.7 inch.
The user is able to set the personal target value and the device will flash the value when the measured blood pressure value exceeds the target one. Further, HL168KF feature a built-in Bluetooth Data Transmission function, which enables the device automatically transmit measuring results to paired Bluetooth device after measurement.
MOCACARE CORP.
White (HL168KF)
In Commercial Distribution
- 00850842006063 ()
- Automatic-inflation electronic sphygmomanometer, portable, arm/wrist
MRCP+ v2 is a standalone software medical device. The purpose of the MRCP+ v2 device is to assist a trained operator with the quantitative evaluation of biliary system structures acquired from magnetic resonance (MR) images from a single time-point (a patient visit). A Perspectum-trained operator loads previously acquired magnetic resonance cholangiopancreatography (MRCP) data as input into the MRCP+ v2 device. A structured summary report is generated as output by the device, which includes quantitative analysis results and geometric characteristics of the biliary system and pancreatic ducts. The MRCP+ v2 report is intended to facilitate reporting by a radiologist for subsequent interpretation and to aid diagnosis by a physician as part of a panel of testing, including conventional radiological tools.
PERSPECTUM LTD
2.0.0
In Commercial Distribution
- B554MRCP2000 ()
- Radiology DICOM image processing application software
UNIT CART PREMIUM-ELEC. 100-120VAC Universal device cart with reinforced bridge for mounting swivel arms, incl. rear panel and integrated cable duct. 3 shelf units (width 370 mm), 2 of which continuously adjustable. 4 double casters, 2 of which with dual-function locking (directional locking/freewheeling/full locking), 2 electrically conductive casters. Interfaces for mounting swivel arms and attaching comprehensive accessories. color: white, RAL 9016, side profiles made of aluminum. dimensions (WxHxD): 720 x 1,518 x 700 mm. Cart including PREMIUM ELECTRICS 100-120V, consisting of: basic housing (premium version) with integrated isolating transformer 100- 120V, insulation monitoring unit and shutdown module, socket strip with main switch module, insulation monitor display and 12 sockets, 6 device connection cables.
Richard Wolf GmbH
32116013
In Commercial Distribution
- 04055207025024 ()
32116013
- Medical device integration rack
The Cydar EV software produces automated 3D overlays for use in endovascular surgery. The software detects vertebral anatomical information present in live X-ray images and matches ('registers') it to an existing CT scan of the patient in order to determine their precise position. This match then allows a 3D overlay to be generated in the correct position and projection. The Cydar EV software is hosted on cloud high-performance computers in order to accelerate performance
Cydar EV works with both flat panel detectors and image intensifiers on fixed and mobile X-ray sets. The Cydar EV Instructions for Use remain the same for all types of X-ray set.
Note: Federal law (US) restricts this device to sale by or on the order of a physician.
CYDAR LIMITED
EV-2
In Commercial Distribution
- 05060508110002 ()
- Angiographic x-ray system application software
The portable x-ray system, DHX-70H is an x-ray generating device which is mainly designed for dental examination. So the device can be used in a hospital and a dental clinic as required. And with the advantage of the portability, it can be used for the military field or the people who have mobility difficulties. Users (operators) of the device should be at the skilled and well trained level of dentist, hygienist, radiologist, nurse, or a dental technician. Since the device generates radiation, it should be prescription use only. The device consists of control panel, high voltage generator, x-ray tube, rechargeable battery, charger, and software.
And the device can be used with dental x-ray film, digital intraoral sensor, or phosphor plate to capture x-ray images.
DigiMed Co., Ltd.
1
In Commercial Distribution
- 18800021800134 ()
- 08800021800137 ()
- 28800021800131 ()
- 38800021800138 ()
- 48800021800135 ()
- 58800021800132 ()
- 68800021800139 ()
- 78800021800136 ()
- 88800021800133 ()
- Diagnostic x-ray system generator, portable
The portable x-ray system, HYBRID Pro is an x-ray generating device which is mainly designed for dental examination. So the device can be used in a hospital and a dental clinic as required. And with the advantage of the portability, it can be used for the military field or the people who have mobility difficulties. Users (operators) of the device should be at the skilled and well trained level of dentist, hygienist, radiologist, nurse, or a dental technician. Since the device generates radiation, it should be prescription use only. The device consists of control panel, high voltage generator, x-ray tube, rechargeable battery, charger, and software.
And the device can be used with dental x-ray film, digital intraoral sensor, or phosphor plate to capture x-ray images.
DigiMed Co., Ltd.
HYBRID Pro
In Commercial Distribution
- 18800021800127 ()
- 08800021800120 ()
- 28800021800124 ()
- 38800021800121 ()
- 48800021800128 ()
- 58800021800125 ()
- 68800021800122 ()
- 78800021800129 ()
- 88800021800126 ()
- Diagnostic x-ray system generator, portable
The portable x-ray system, HYBRID C70 is an x-ray generating device which is mainly designed for dental examination. So the device can be used in a hospital and a dental clinic as required. And with the advantage of the portability, it can be used for the military field or the people who have mobility difficulties. Users (operators) of the device should be at the skilled and well trained level of dentist, hygienist, radiologist, nurse, or a dental technician. Since the device generates radiation, it should be prescription use only. The device consists of control panel, high voltage generator, x-ray tube, rechargeable battery, charger, and software.
And the device can be used with dental x-ray film, digital intraoral sensor, or phosphor plate to capture x-ray images.
DigiMed Co., Ltd.
HYBRID C70
In Commercial Distribution
- 18800021800110 ()
- 08800021800113 ()
- 28800021800117 ()
- 38800021800114 ()
- 48800021800111 ()
- 58800021800118 ()
- 68800021800115 ()
- 78800021800112 ()
- 88800021800119 ()
- Diagnostic x-ray system generator, portable
The portable x-ray system, HYBRID S70 is an x-ray generating device which is mainly designed for dental examination. So the device can be used in a hospital and a dental clinic as required. And with the advantage of the portability, it can be used for the military field or the people who have mobility difficulties. Users (operators) of the device should be at the skilled and well trained level of dentist, hygienist, radiologist, nurse, or a dental technician. Since the device generates radiation, it should be prescription use only. The device consists of control panel, high voltage generator, x-ray tube, rechargeable battery, charger, and software.
And the device can be used with dental x-ray film, digital intraoral sensor, or phosphor plate to capture x-ray images.
DigiMed Co., Ltd.
1
In Commercial Distribution
- 18800021800103 ()
- 08800021800106 ()
- 28800021800100 ()
- 38800021800107 ()
- 48800021800104 ()
- 58800021800101 ()
- 68800021800108 ()
- 78800021800105 ()
- 88800021800102 ()
- Diagnostic x-ray system generator, portable
The portable x-ray system, BIOX is an x-ray generating device which is mainly designed for dental examination. So the device can be used in a hospital and a dental clinic as required. And with the advantage of the portability, it can be used for the military field or the people who have mobility difficulties. Users (operators) of the device should be at the skilled and well trained level of dentist, hygienist, radiologist, nurse, or a dental technician. Since the device generates radiation, it should be prescription use only. The device consists of control panel, high voltage generator, x-ray tube, rechargeable battery, charger, and software.
And the device can be used with dental x-ray film, digital intraoral sensor, or phosphor plate to capture x-ray images.
DigiMed Co., Ltd.
1
In Commercial Distribution
- 18800021800042 ()
- 08800021800045 ()
- 28800021800049 ()
- 38800021800046 ()
- 48800021800043 ()
- 58800021800040 ()
- 68800021800047 ()
- 78800021800044 ()
- 88800021800041 ()
- Diagnostic x-ray system generator, portable
The Piccolo® General Chemistry 6 , used with the Piccolo® blood chemistry analyzer or the Piccolo Xpress® chemistry analyzer, is intended to be used for the in vitro quantitative determination of alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine, gamma glutamyltransferase (GGT), glucose, and blood urea nitrogen (BUN) in heparinized whole blood, heparinized plasma, or serum in a clinical laboratory setting or point-of-care location.
The tests on this panel are waived under CLIA ’88 regulations. If a laboratory modifies the test system instructions, then the tests are considered high complexity and subject to all CLIA requirements. For CLIA waived labs, only lithium heparin whole blood may be tested. For use in moderate complexity labs, lithium heparinized whole blood, lithium heparinized plasma, or serum may be used.
ABAXIS, INC.
400-0006
In Commercial Distribution
- EABA40000061 ()
- EABA40000060 ()
400-0006
- Gamma-glutamyltransferase (GGT) IVD, reagent
- Alanine aminotransferase (ALT) IVD, reagent
- Urea IVD, reagent
- Creatinine IVD, reagent
- Glucose IVD, reagent
- Total aspartate aminotransferase (AST) IVD, reagent
Visaris Avanse® is a digital radiography imaging, control and management software (for imaging consoles) that works with DR flat panel detectors technology. Visaris Avanse® PACS provides functionality for digital radiography examinations from patient search and entry, generator control,image acquisition and processing to DICOM data archiving and export. Visaris Avanse® PACS can also include a number of Digital Radiology modules such as network DICOM archive (PACS module), DICOM modality worklist module and diagnostic workstation software to turn it into digital radiology department on a PC for small clinics. Visaris Avanse ® is autonomous software and involves no hardware. It runs under the MS Windows XP/7/8 operating system on any hardware platform meeting the minimum system requirements.
VISARIS DOO
Avanse DR
In Commercial Distribution
- 08606102809033 ()
- Radiological PACS software
The ophthalmic YAG laser system YC-1800 emits Nd: YAG laser (hereafter called “YAG laser”) pulse beam by Q-switching. The YC-1800 allows the safe and bloodless treatment of intraocular diseases for outpatients by mechanical disruption caused by energy of the YAG laser pulses. The main purposes
of the YC-1800 are posterior capsulotomy for secondary cataract, iridotomy for acute angle-closure glaucoma, and for pupillary membranectomy for traction retinal detachment. The YC-1800 has a slit lamp for observation that includes the YAG laser and its controlling mechanism. The YC-1800 is also equipped with an operation panel and knobs that facilitate operation. The compact and lightweight power supply box is installed separately for lightness and compactness of the system. In addition, a motorized table for the YC-1800 is available optionally.
NIDEK CO.,LTD.
YC-1800
In Commercial Distribution
- 04987669100073 ()
- Ophthalmic solid-state laser system, photodisruption
Duo kit
HYGITECH
Reference: HY-09011
The DUO kit is the kit needed for dressing both the surgeon and his assistant. some environment protection is also included, which makes this kit perfect for all kinds of procedures. The kit is composed of 32 items.
4 Polyethylene gloves
1 surgical drape (29.5"x 29.5"/ 75x75cm)
2 Elastic cap handle covers
2 Protective sleeves for tubing (3.5"x 47"/ 8x120cm)
3 non-latex elastic bands
1 Adhesive protective cover for control panel (6.3"x 8.9"/ 16x22cm)
1 surgical cap
2 Bouffant caps
2 tie-on masks
2 Pairs of overshoes
1 surgical brush with nail cleaner
4 Paper hand-towels
1 assistant gown with cotton cuffs
1 surgical gown with cotton cuffs
1 U-shaped surgical drape with adhesive (31.5"x 39"/ 80x100cm)
1 Wrapping paper
HYGITECH
HY-09011
In Commercial Distribution
- 03615140005302 ()
- 03615140005296 ()
HY-09011
- Denture repair kit, professional
The PROTECT kit is HYGITECH’s best selling kit, designed to meet all needs for any type of implant surgery.
The kit is composed of 45 items:
4 Polyethylene gloves
1 Instrument table cover (bridge) (90x120cm)
1 Surgical drape (75x75cm)
2 Protective sleeves for tubing (8cmx120cm)
1 Tube support with adhesive
2 Elastic cap handle covers
1 Protective PVC X-ray cover
2 Adhesive protective covers for control panel
3 Non-latex elastic bands
1 Adhesive film 5x80cm
1 Surgical hat
2 Bouffant caps
2 Tie-on masks
3 Pairs of overshoes
2 Sterile brushes with nail cleaner
6 Paper hand-towels
1 Surgical gown with cotton cuffs
1 Assistant gown with cotton cuffs
1 Patient gown with cotton cuffs
1 Surgical drape with aperture and adhesive (70x100cm)
1 U-shaped surgical drape with adhesive (100x150cm)
1 impermeable wrapping paper
HYGITECH
HY-0871
In Commercial Distribution
- 03615140005265 ()
- 03615140005258 ()
HY-0871
- Surgical dressing/drape kit, single-use
The Youha, Bebebao, and Yiyadodo electric breast pumps are single-user, powered breast pump intended to be used by lactating women to express and collect milk from their breasts. THE ONE, YH-8012, BB-5020 and YY-5030 have both single (pumping from one breast) and double pumping (pumping from both breasts) configurations. YY-8011 and YH-8019 have a single pumping configuration only.
A reciprocating diaphragm vacuum pump, driven by a microprocessor, generates the suction to extract the milk at vacuum levels up to 280 mmHg. The user interface for the THE ONE, YH-8012, BB-5020 and YY-5030 models consists of a front panel keypad and LCD display or LED display in which the user switches between modes and controls the vacuum pressure. The YY-5030 model does not have any visual indicators on the pump housing.
Ningbo Youhe Electrical Appliance Technology Co., Ltd
YH-8015
In Commercial Distribution
- 16957031400044 ()
- 06957031400047 ()
- Breast pump, electric
The Youha, Bebebao, and Yiyadodo electric breast pumps are single-user, powered breast pump intended to be used by lactating women to express and collect milk from their breasts. THE ONE, YH-8012, BB-5020 and YY-5030 have both single (pumping from one breast) and double pumping (pumping from both breasts) configurations. YY-8011 and YH-8019 have a single pumping configuration only.
A reciprocating diaphragm vacuum pump, driven by a microprocessor, generates the suction to extract the milk at vacuum levels up to 280 mmHg. The user interface for the THE ONE, YH-8012, BB-5020 and YY-5030 models consists of a front panel keypad and LCD display or LED display in which the user switches between modes and controls the vacuum pressure. The YY-5030 model does not have any visual indicators on the pump housing.
Ningbo Youhe Electrical Appliance Technology Co., Ltd
YH-8006IV
In Commercial Distribution
- 16957031400037 ()
- 06957031400030 ()
- Breast pump, electric
The Youha, Bebebao, and Yiyadodo electric breast pumps are single-user, powered breast pump intended to be used by lactating women to express and collect milk from their breasts. THE ONE, YH-8012, BB-5020 and YY-5030 have both single (pumping from one breast) and double pumping (pumping from both breasts) configurations. YY-8011 and YH-8019 have a single pumping configuration only.
A reciprocating diaphragm vacuum pump, driven by a microprocessor, generates the suction to extract the milk at vacuum levels up to 280 mmHg. The user interface for the THE ONE, YH-8012, BB-5020 and YY-5030 models consists of a front panel keypad and LCD display or LED display in which the user switches between modes and controls the vacuum pressure. The YY-5030 model does not have any visual indicators on the pump housing.
Ningbo Youhe Electrical Appliance Technology Co., Ltd
YH-8016
In Commercial Distribution
- 16957031400020 ()
- 06957031400023 ()
- Breast pump, electric
The Youha, Bebebao, and Yiyadodo electric breast pumps are single-user, powered breast pump intended to be used by lactating women to express and collect milk from their breasts. THE ONE, YH-8012, BB-5020 and YY-5030 have both single (pumping from one breast) and double pumping (pumping from both breasts) configurations. YY-8011 and YH-8019 have a single pumping configuration only.
A reciprocating diaphragm vacuum pump, driven by a microprocessor, generates the suction to extract the milk at vacuum levels up to 280 mmHg. The user interface for the THE ONE, YH-8012, BB-5020 and YY-5030 models consists of a front panel keypad and LCD display or LED display in which the user switches between modes and controls the vacuum pressure. The YY-5030 model does not have any visual indicators on the pump housing.
Ningbo Youhe Electrical Appliance Technology Co., Ltd
YH-8004
In Commercial Distribution
- 16957031400013 ()
- 06957031400016 ()
- Breast pump, electric
The Piccolo® General Chemistry 13 used with the Piccolo blood chemistry analyzer or the Piccolo Xpress® chemistry analyzer, is intended to be used for the in vitro quantitative determination of alanine aminotransferase (ALT), albumin, alkaline phosphatase (ALP), amylase, aspartate aminotransferase (AST), calcium, creatinine, gamma glutamyltransferase (GGT), glucose, total bilirubin, total protein, blood urea nitrogen (BUN), and uric acid in heparinized whole blood, heparinized plasma, or serum in a clinical laboratory setting or point-of-care location.
The tests on this panel are waived under CLIA ’88 regulations. If a laboratory modifies the test system instructions, then the tests are considered high complexity and subject to all CLIA requirements. For CLIA waived labs, only lithium heparin whole blood may be tested. For use in moderate complexity labs, lithium heparinized whole blood, lithium heparinized plasma, or serum may be used.
ABAXIS, INC.
400-0029
In Commercial Distribution
- EABA40000291 ()
- EABA40000290 ()
400-0029
- Total aspartate aminotransferase (AST) IVD, reagent
- Glucose IVD, reagent
- Total bilirubin IVD, reagent
- Total protein IVD, reagent
- Uric acid IVD, reagent
- Creatinine IVD, reagent
- Urea IVD, reagent
- Alanine aminotransferase (ALT) IVD, reagent
- Total alkaline phosphatase (ALP) IVD, reagent
- Total amylase IVD, reagent
- Calcium (Ca2+) IVD, reagent
- Gamma-glutamyltransferase (GGT) IVD, reagent
- Albumin IVD, reagent
Mains powered, infrared phototherapy device emitting up to 9 W at 980 nm. The LightForce PRO (LTC-900) is indicated for emitting energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for temporary relief of minor muscle and joint pain, muscle spasm, pain and stiffness associated with arthritis and promoting. relaxation of the muscle tissue and to temporarily increase local blood circulation.
The PRO is a compact, portable medical laser therapy system. The laser light delivery system consists of a flexible optical fiber threaded through a lightweight hand piece. Activation occurs when the operator enables the laser and presses the finger switch. Depending on laser system configuration, the finger switch can function as an on/off switch. A touch-screen display panel allows the operator to adjust or set laser output level. The laser can operate in continuous wave mode or controlled pulse mode.
LITECURE LLC
LTC-900
In Commercial Distribution
- 00854103007004 ()
- Musculoskeletal infrared phototherapy unit, non-wearable
AI Metrics is a thin client software application used with general purpose computing hardware for the display and visualization of medical image data, supporting images and anatomical datasets, such as CT and MR. AI Metrics is designed as a workflow automation application with analytical tools to help the user assess, categorize and document the extent of a disease and/or tumor response to therapy in accordance with user selected standards (e.g. RECIST 1.1) and assess changes in imaging findings over multiple time-points. AI Metrics supports the interpretation and evaluation of examinations and follow up documentation of findings within healthcare institutions, for example, in Radiology, Oncology, and other Medical Imaging environments. AI Metrics functionality provides for communication, storage, processing, rendering, and display of DICOM compliant image data derived from various sources, navigation through images, selection of regions of interest, generation of information from those regions, evaluation in accordance with user selected standards, and generation of a structured report. The user controls these functions with a system of interactive menus and semi-automated or manual workflow automation tools, including:
• Manual annotation tools for users to select regions of interest (ROIs),
• Semi-automatic lesion segmentation suggestions for user-selected ROIs,
• Automatic measurement and display of long and short axis of segmented lesions,
• Automatic tabulation and summation of measurements,
• Semi-automatic lesion labelling suggestions for anatomical location (organ, body region, and laterality),
• Automatic calculation of quantitative and qualitative metrics using annotation data in accordance with the selected criteria, and
• Automatic generation of a structured report that includes the annotation data and calculated quantitative and qualitative metrics presented in a graph, table, key images, and structured text report.
Ai Metrics, LLC
1
In Commercial Distribution
- G090AIM11 ()
AIM1
- Radiological PACS software
The Genadyne UNO is a single use Negative Pressure Wound Therapy (NPWT) Unit designed for moderate to low severity wounds. The Genadyne UNO NPWT Unit has a pre-determined lifespan. The unit features an interface panel which provides alert and information signals and selectable therapy options. This unit provides negative pressure at either 80 mmHg or 125 mmHg, and offers selections of Continuous Mode at 80mmHg / 30mmHg or 125mmHg / 30mmHg in Variable Mode. The Genadyne UNO Therapy Kits include a therapy unit, 70 cc canisters, USB charger, USB cable and sterile dressing kits. Dressing kits and canisters for the Genadyne UNO could be provided separately. Dressing should be changed in line with standard wound dressing guidelines, typically every 3 days. More frequent changes may be required depending on level of exudate, condition of dressing, wound type/sizes, orientation of the dressing, environmental considerations or other patient considerations; e.g. when UNO is used on infected wounds.
GENADYNE BIOTECHNOLOGIES INC.
U-S2525-6
In Commercial Distribution
- 00849405011699 ()
- Negative-pressure wound therapy system, electric, single-use
The Genadyne UNO is a single use Negative Pressure Wound Therapy (NPWT) Unit designed for moderate to low severity wounds. The Genadyne UNO NPWT Unit has a pre-determined lifespan. The unit features an interface panel which provides alert and information signals and selectable therapy options. This unit provides negative pressure at either 80 mmHg or 125 mmHg, and offers selections of Continuous Mode at 80mmHg / 30mmHg or 125mmHg / 30mmHg in Variable Mode. The Genadyne UNO Therapy Kits include a therapy unit, 70 cc canisters, USB charger, USB cable and sterile dressing kits. Dressing kits and canisters for the Genadyne UNO could be provided separately. Dressing should be changed in line with standard wound dressing guidelines, typically every 3 days. More frequent changes may be required depending on level of exudate, condition of dressing, wound type/sizes, orientation of the dressing, environmental considerations or other patient considerations; e.g. when UNO is used on infected wounds.
GENADYNE BIOTECHNOLOGIES INC.
U-S2025-6
In Commercial Distribution
- 00849405011682 ()
- Negative-pressure wound therapy system, electric, single-use
The Genadyne UNO is a single use Negative Pressure Wound Therapy (NPWT) Unit designed for moderate to low severity wounds. The Genadyne UNO NPWT Unit has a pre-determined lifespan. The unit features an interface panel which provides alert and information signals and selectable therapy options. This unit provides negative pressure at either 80 mmHg or 125 mmHg, and offers selections of Continuous Mode at 80mmHg / 30mmHg or 125mmHg / 30mmHg in Variable Mode. The Genadyne UNO Therapy Kits include a therapy unit, 70 cc canisters, USB charger, USB cable and sterile dressing kits. Dressing kits and canisters for the Genadyne UNO could be provided separately. Dressing should be changed in line with standard wound dressing guidelines, typically every 3 days. More frequent changes may be required depending on level of exudate, condition of dressing, wound type/sizes, orientation of the dressing, environmental considerations or other patient considerations; e.g. when UNO is used on infected wounds.
GENADYNE BIOTECHNOLOGIES INC.
U-S2020-6
In Commercial Distribution
- 00849405011675 ()
- Negative-pressure wound therapy system, electric, single-use
The Genadyne UNO is a single use Negative Pressure Wound Therapy (NPWT) Unit designed for moderate to low severity wounds. The Genadyne UNO NPWT Unit has a pre-determined lifespan. The unit features an interface panel which provides alert and information signals and selectable therapy options. This unit provides negative pressure at either 80 mmHg or 125 mmHg, and offers selections of Continuous Mode at 80mmHg / 30mmHg or 125mmHg / 30mmHg in Variable Mode. The Genadyne UNO Therapy Kits include a therapy unit, 70 cc canisters, USB charger, USB cable and sterile dressing kits. Dressing kits and canisters for the Genadyne UNO could be provided separately. Dressing should be changed in line with standard wound dressing guidelines, typically every 3 days. More frequent changes may be required depending on level of exudate, condition of dressing, wound type/sizes, orientation of the dressing, environmental considerations or other patient considerations; e.g. when UNO is used on infected wounds.
GENADYNE BIOTECHNOLOGIES INC.
U-S1530-6
In Commercial Distribution
- 00849405011668 ()
- Negative-pressure wound therapy system, electric, single-use
The Genadyne UNO is a single use Negative Pressure Wound Therapy (NPWT) Unit designed for moderate to low severity wounds. The Genadyne UNO NPWT Unit has a pre-determined lifespan. The unit features an interface panel which provides alert and information signals and selectable therapy options. This unit provides negative pressure at either 80 mmHg or 125 mmHg, and offers selections of Continuous Mode at 80mmHg / 30mmHg or 125mmHg / 30mmHg in Variable Mode. The Genadyne UNO Therapy Kits include a therapy unit, 70 cc canisters, USB charger, USB cable and sterile dressing kits. Dressing kits and canisters for the Genadyne UNO could be provided separately. Dressing should be changed in line with standard wound dressing guidelines, typically every 3 days. More frequent changes may be required depending on level of exudate, condition of dressing, wound type/sizes, orientation of the dressing, environmental considerations or other patient considerations; e.g. when UNO is used on infected wounds.
GENADYNE BIOTECHNOLOGIES INC.
U-S1520-6
In Commercial Distribution
- 00849405011651 ()
- Negative-pressure wound therapy system, electric, single-use
The Genadyne UNO is a single use Negative Pressure Wound Therapy (NPWT) Unit designed for moderate to low severity wounds. The Genadyne UNO NPWT Unit has a pre-determined lifespan. The unit features an interface panel which provides alert and information signals and selectable therapy options. This unit provides negative pressure at either 80 mmHg or 125 mmHg, and offers selections of Continuous Mode at 80mmHg / 30mmHg or 125mmHg / 30mmHg in Variable Mode. The Genadyne UNO Therapy Kits include a therapy unit, 70 cc canisters, USB charger, USB cable and sterile dressing kits. Dressing kits and canisters for the Genadyne UNO could be provided separately. Dressing should be changed in line with standard wound dressing guidelines, typically every 3 days. More frequent changes may be required depending on level of exudate, condition of dressing, wound type/sizes, orientation of the dressing, environmental considerations or other patient considerations; e.g. when UNO is used on infected wounds.
GENADYNE BIOTECHNOLOGIES INC.
U-S1515-6
In Commercial Distribution
- 00849405011644 ()
- Negative-pressure wound therapy system, electric, single-use
The Genadyne UNO is a single use Negative Pressure Wound Therapy (NPWT) Unit designed for moderate to low severity wounds. The Genadyne UNO NPWT Unit has a pre-determined lifespan. The unit features an interface panel which provides alert and information signals and selectable therapy options. This unit provides negative pressure at either 80 mmHg or 125 mmHg, and offers selections of Continuous Mode at 80mmHg / 30mmHg or 125mmHg / 30mmHg in Variable Mode. The Genadyne UNO Therapy Kits include a therapy unit, 70 cc canisters, USB charger, USB cable and sterile dressing kits. Dressing kits and canisters for the Genadyne UNO could be provided separately. Dressing should be changed in line with standard wound dressing guidelines, typically every 3 days. More frequent changes may be required depending on level of exudate, condition of dressing, wound type/sizes, orientation of the dressing, environmental considerations or other patient considerations; e.g. when UNO is used on infected wounds.
GENADYNE BIOTECHNOLOGIES INC.
U-S1040-6
In Commercial Distribution
- 00849405011637 ()
- Negative-pressure wound therapy system, electric, single-use
The Genadyne UNO is a single use Negative Pressure Wound Therapy (NPWT) Unit designed for moderate to low severity wounds. The Genadyne UNO NPWT Unit has a pre-determined lifespan. The unit features an interface panel which provides alert and information signals and selectable therapy options. This unit provides negative pressure at either 80 mmHg or 125 mmHg, and offers selections of Continuous Mode at 80mmHg / 30mmHg or 125mmHg / 30mmHg in Variable Mode. The Genadyne UNO Therapy Kits include a therapy unit, 70 cc canisters, USB charger, USB cable and sterile dressing kits. Dressing kits and canisters for the Genadyne UNO could be provided separately. Dressing should be changed in line with standard wound dressing guidelines, typically every 3 days. More frequent changes may be required depending on level of exudate, condition of dressing, wound type/sizes, orientation of the dressing, environmental considerations or other patient considerations; e.g. when UNO is used on infected wounds.
GENADYNE BIOTECHNOLOGIES INC.
U-S1030-6
In Commercial Distribution
- 00849405011620 ()
- Negative-pressure wound therapy system, electric, single-use
The Genadyne UNO is a single use Negative Pressure Wound Therapy (NPWT) Unit designed for moderate to low severity wounds. The Genadyne UNO NPWT Unit has a pre-determined lifespan. The unit features an interface panel which provides alert and information signals and selectable therapy options. This unit provides negative pressure at either 80 mmHg or 125 mmHg, and offers selections of Continuous Mode at 80mmHg / 30mmHg or 125mmHg / 30mmHg in Variable Mode. The Genadyne UNO Therapy Kits include a therapy unit, 70 cc canisters, USB charger, USB cable and sterile dressing kits. Dressing kits and canisters for the Genadyne UNO could be provided separately. Dressing should be changed in line with standard wound dressing guidelines, typically every 3 days. More frequent changes may be required depending on level of exudate, condition of dressing, wound type/sizes, orientation of the dressing, environmental considerations or other patient considerations; e.g. when UNO is used on infected wounds.
GENADYNE BIOTECHNOLOGIES INC.
U-S1020-6
In Commercial Distribution
- 00849405011613 ()
- Negative-pressure wound therapy system, electric, single-use
The Genadyne UNO is a single use Negative Pressure Wound Therapy (NPWT) Unit designed for moderate to low severity wounds. The Genadyne UNO NPWT Unit has a pre-determined lifespan. The unit features an interface panel which provides alert and information signals and selectable therapy options. This unit provides negative pressure at either 80 mmHg or 125 mmHg, and offers selections of Continuous Mode at 80mmHg / 30mmHg or 125mmHg / 30mmHg in Variable Mode. The Genadyne UNO Therapy Kits include a therapy unit, 70 cc canisters, USB charger, USB cable and sterile dressing kits. Dressing kits and canisters for the Genadyne UNO could be provided separately. Dressing should be changed in line with standard wound dressing guidelines, typically every 3 days. More frequent changes may be required depending on level of exudate, condition of dressing, wound type/sizes, orientation of the dressing, environmental considerations or other patient considerations; e.g. when UNO is used on infected wounds.
GENADYNE BIOTECHNOLOGIES INC.
U-S0006
In Commercial Distribution
- 00849405011606 ()
- Negative-pressure wound therapy system, electric, single-use
The Genadyne UNO is a single use Negative Pressure Wound Therapy (NPWT) Unit designed for moderate to low severity wounds. The Genadyne UNO NPWT Unit has a pre-determined lifespan. The unit features an interface panel which provides alert and information signals and selectable therapy options. This unit provides negative pressure at either 80 mmHg or 125 mmHg, and offers selections of Continuous Mode at 80mmHg / 30mmHg or 125mmHg / 30mmHg in Variable Mode. The Genadyne UNO Therapy Kits include a therapy unit, 70 cc canisters, USB charger, USB cable and sterile dressing kits. Dressing kits and canisters for the Genadyne UNO could be provided separately. Dressing should be changed in line with standard wound dressing guidelines, typically every 3 days. More frequent changes may be required depending on level of exudate, condition of dressing, wound type/sizes, orientation of the dressing, environmental considerations or other patient considerations; e.g. when UNO is used on infected wounds.
GENADYNE BIOTECHNOLOGIES INC.
U-S00R5
In Commercial Distribution
- 00849405001614 ()
- Negative-pressure wound therapy system, electric, single-use
The Genadyne UNO is a single use Negative Pressure Wound Therapy (NPWT) Unit designed for moderate to low severity wounds. The Genadyne UNO NPWT Unit has a pre-determined lifespan. The unit features an interface panel which provides alert and information signals and selectable therapy options. This unit provides negative pressure at either 80 mmHg or 125 mmHg, and offers selections of Continuous Mode at 80mmHg / 30mmHg or 125mmHg / 30mmHg in Variable Mode. The Genadyne UNO Therapy Kits include a therapy unit, 70 cc canisters, USB charger, USB cable and sterile dressing kits. Dressing kits and canisters for the Genadyne UNO could be provided separately. Dressing should be changed in line with standard wound dressing guidelines, typically every 3 days. More frequent changes may be required depending on level of exudate, condition of dressing, wound type/sizes, orientation of the dressing, environmental considerations or other patient considerations; e.g. when UNO is used on infected wounds.
GENADYNE BIOTECHNOLOGIES INC.
U-S1010-6
In Commercial Distribution
- 00849405001478 ()
- Negative-pressure wound therapy system, electric, single-use
The Genadyne UNO is a single use Negative Pressure Wound Therapy (NPWT) Unit designed for moderate to low severity wounds. The Genadyne UNO NPWT Unit has a pre-determined lifespan. The unit features an interface panel which provides alert and information signals and selectable therapy options. This unit provides negative pressure at either 80 mmHg or 125 mmHg, and offers selections of Continuous Mode at 80mmHg / 30mmHg or 125mmHg / 30mmHg in Variable Mode. The Genadyne UNO Therapy Kits include a therapy unit, 70 cc canisters, USB charger, USB cable and sterile dressing kits. Dressing kits and canisters for the Genadyne UNO could be provided separately. Dressing should be changed in line with standard wound dressing guidelines, typically every 3 days. More frequent changes may be required depending on level of exudate, condition of dressing, wound type/sizes, orientation of the dressing, environmental considerations or other patient considerations; e.g. when UNO is used on infected wounds.
GENADYNE BIOTECHNOLOGIES INC.
U-S1010-5
In Commercial Distribution
- 00849405000532 ()
- Negative-pressure wound therapy system, electric, single-use
The Genadyne UNO is a single use Negative Pressure Wound Therapy (NPWT) Unit designed for moderate to low severity wounds. The Genadyne UNO NPWT Unit has a pre-determined lifespan. The unit features an interface panel which provides alert and information signals and selectable therapy options. This unit provides negative pressure at either 80 mmHg or 125 mmHg, and offers selections of Continuous Mode at 80mmHg / 30mmHg or 125mmHg / 30mmHg in Variable Mode. The Genadyne UNO Therapy Kits include a therapy unit, 70 cc canisters, USB charger, USB cable and sterile dressing kits. Dressing kits and canisters for the Genadyne UNO could be provided separately. Dressing should be changed in line with standard wound dressing guidelines, typically every 3 days. More frequent changes may be required depending on level of exudate, condition of dressing, wound type/sizes, orientation of the dressing, environmental considerations or other patient considerations; e.g. when UNO is used on infected wounds.
GENADYNE BIOTECHNOLOGIES INC.
U-S2525-5
In Commercial Distribution
- 00849405011590 ()
- Negative-pressure wound therapy system, electric, single-use