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The HeRO (Hemodialysis Reliable Outflow) Graft is a long-term access solution for access-challenged and catheter-dependent patients. HeRO Graft is a fully subcutaneous surgical implant. It provides arterial venous (AV) access with continuous outflow into the central venous system. HeRO Graft traverses central venous stenosis allowing for long-term hemodialysis access.
HeRO Graft consists of two primary components:
• A proprietary Venous Outflow Component
• A proprietary Arterial Graft Component
The HeRO Graft Venous Outflow Component has a 5mm inner diameter (ID), 19F outer diameter (OD), and is 40cm long. It consists of radiopaque silicone with braided nitinol reinforcement (for kink and crush resistance) and a radiopaque marker band at the tip.
Artivion, Inc.
HERO 1001
Not in Commercial Distribution
- 00877234000065 ()
- Outer Diamter: 19 French
- Lumen/Inner Diameter: 5 Millimeter
- Length: 40 Centimeter
HERO 1001
- Arteriovenous shunt
The Accelerate Pheno™ system is a fully-integrated in vitro diagnostic system comprised of one to four module(s), a Control PC, Analysis PC(s), touchscreen monitor and Accelerate Pheno system software for use with Accelerate PhenoTest™ kits. It is designed to perform identification (ID) and quantitation of bacterial and yeast cells in less than 90 minutes and antimicrobial susceptibility testing (AST) on average in less than 7 hours directly from patient samples.
Identification uses fluorescence in situ hybridization (FISH) and susceptibility testing uses microscopic observation of individual, live, growing bacterial cells in near real time (approximately every 10 minutes) in the presence of antimicrobial agents.
ACCELERATE DIAGNOSTICS, INC.
10301008
In Commercial Distribution
- 00862011000321 ()
- 10862011000328 ()
- Multiple-type bloodstream pathogen nucleic acid IVD, kit, nucleic acid amplification/mass spectrometry
The Accelerate Pheno™ system is a fully-integrated in vitro diagnostic system comprised of one to four module(s), a Control PC, Analysis PC(s), touchscreen monitor and Accelerate Pheno system software for use with Accelerate PhenoTest™ kits. It is designed to perform identification (ID) and quantitation of bacterial and yeast cells in less than 90 minutes and antimicrobial susceptibility testing (AST) on average in less than 7 hours directly from patient samples.
Identification uses fluorescence in situ hybridization (FISH) and susceptibility testing uses microscopic observation of individual, live, growing bacterial cells in near real time (approximately every 10 minutes) in the presence of antimicrobial agents.
ACCELERATE DIAGNOSTICS, INC.
10401008
In Commercial Distribution
- 00862011000314 ()
- 10862011000311 ()
- Multiple-type bloodstream pathogen nucleic acid IVD, kit, nucleic acid amplification/mass spectrometry
The Laerdal Silicone Resuscitator is a self-inflating manual resuscitator that is intended for patients requiring total or intermittent ventilatory support. The Laerdal Silicone Resuscitator provides positive pressure ventilation and allows spontaneous breathing either with a 22 mm ID (inner diameter) face - mask port, through an artificial airway or with a facemask that has a 15 mm OD (outer diameter) connection. The Preterm model is intended for patients below 2,5 kg (5,5 lb), the Paediatric model is intended for patients from 2,5 (5,5 lb) to 25 kg (55 lb), and the Adult model is intended for pati - ents over 25 kg (55 lb).
Commercial Distribution
Laerdal Medical AS
86005240
In Commercial Distribution
- 07045430045262 ()
86005240
- Pulmonary resuscitator, manual, reusable
The Pathfinder® CR System is a disposable endoscopy fluid management system for the 14mm ID Pathfinder®Endoscope Overtube. It is designed to evacuate retained blood, free-floating blood clots, and fluid from the stomach in adult patients (22 years of age or older). It also provides access for endoscopic device passage and exchange. The suction adapter is attached to the Overtube and connected to a foot pedal to control suction on/off functionality. The foot pedal is connected to a suction source with vacuum regulator that provides a range between 200 to 375 mmHg (26.7 to 50.0 kPa). It is for use only by medically licensed and trained gastroenterologists located in hospitals, clinics, and doctor offices.
NEPTUNE MEDICAL INC.
GI 014CR-1
In Commercial Distribution
- 00850006222322 ()
- Endoscope suction valve, single-use
The IntelliVue MX750 Patient Monitor has an optically-bonded 19 inch (469 mm) LCD (TFT) widescreen display with projected capacitive touch technology. It is compatible with various measurement modules and measurement servers. The monitor provides as standard a 100BaseT LAN port, an RS232 port, four USB ports, a basic nurse call relay, and an analog ECG sync output. MX750 also provides one MSL connector for connecting up to two FMX-4 module racks (in the case of two racks, the racks are connected to each other in series and then plugged in to the MSL connector). Built-in to the front of the display is a Contactless ID and Communication module using RFID technology. Please refer to technical data sheet for more information.
Philips Medizin Systeme Böblingen GmbH
IntelliVue Patient Monitor MX750
In Commercial Distribution
- 00884838083332 ()
866471
- Multiple vital physiological parameter monitoring system, clinical
The HeRO (Hemodialysis Reliable Outflow) Graft is a long-term access solution for access-challenged and catheter-dependent patients. HeRO Graft is a fully subcutaneous surgical implant. It provides arterial venous (AV) access with continuous outflow into the central venous system. HeRO Graft traverses central venous stenosis allowing for long-term hemodialysis access.
HeRO Graft consists of two primary components:
• A proprietary Venous Outflow Component
• A proprietary Arterial Graft Component
The HeRO Graft Arterial Graft Component has a 6mm ID, 7.4mm OD, and is 53cm long, inclusive of the connector. It consists of an ePTFE hemodialysis graft with PTFE beading to provide kink resistance near the titanium connector. The titanium connector attaches the Arterial Graft Component to the HeRO Graft Venous Outflow Component. The HeRO Graft Arterial Graft Component is cannulated using standard technique according to KDOQI guidelines.
Artivion, Inc.
HERO 1002
Not in Commercial Distribution
- 00877234000072 ()
- Outer Diameter: 7.4 Millimeter
- Lumen/Inner Diameter: 6 Millimeter
- Length: 53 Centimeter
HERO 1002
- Arteriovenous shunt
A manual surgical instrument that cuts cancellous bone by manual actuation of the
8mm cutting tip. The cap contains a barbed nozzle that connects to standard sized suction tubing (tube with an ID
of 6–10 mm) to connect to a vacuum source, wherein the vacuum source has a static maximum pressure
between 150 mmHg and 300 mmHg. The proposed device can be connected to a waste canister that leads to
standard operating room wall suction or to an external pump. With the device connected to a vacuum
source, when actuated in bone the cutting tip carves, scrapes and cuts cancellous bone and collects the bone
graft inside the handle. The suction pulls the bone and bone marrow from the cutting tip and into the bone
reservoir inside the handle. The cap contains a filter that prevents material from escaping the handle into the
suction system by utilizing a physical sieve to keep bone particulate in the handle. After harvesting, the bone
graft can be retrieved from the handle.
AVITUS ORTHOPAEDICS, INC.
BH8
In Commercial Distribution
- 00857373006005 ()
BH8
- Bone graft harvesting filter
- Neurosurgical curette, single-use
Light weight (~2.5 Kg.) and portable therapeutic medical laser device (measuring ~258.65mm x 238.43m x 88.86mm) disc shaped, indicated for temporary relief of minor muscle and joint pain, stiffness, minor arthritis pain, muscle spasm, temporary increase in local blood circulation, and temporary relaxation of muscles by means of topical elevated tissue temperature from infrared spectral emissions. The noninvasive laser treatments (Continuous Wave - CW power 28W and Intense Super Pulse - ISP power 30W) are in the form of non-ionizing radiation in which the invisible light wave doses (810nm +/- 10nm, 915nm +/- 10nm, 980nm +/- 10nm) and visible light wave aiming beam (650nm +/- 20nm) are not cumulative and do not create changes in cellular DNA. The presence of a temperature gradient generates an increased local blood circulation through the tissue to reduce inflammation and pain and to enhance the rate of tissue repair. The laser energy increases circulation, drawing water, oxygen, and nutrients to the target area. The increase in circulation provides a healing environment that reduces inflammation, swelling, muscle spasm, stiffness, and pain. The increased circulation of blood speeds up the process of respiratory cellular activity by stimulating an increase in hemoglobin and nutrients at the target cell and a decrease in cellular carbon dioxide and lactic acid waste. The laser light therapy promotes the transport of nutrients across the cell membrane to aid in the natural repair mechanism of the target cells by stimulating an increase in production of Adenosine Triphosphate (ATP) energy in the cell. The increase in ATP energy and the decrease in waste enhances cellular function and tissue repair.
SUMMUS MEDICAL LASER, LLC
P4H
In Commercial Distribution
- B679SLP4H0 ()
SLP4H
- Musculoskeletal/physical therapy laser, professional