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LungFit PH Product Description
The LungFit PH System generates nitric oxide (NO) from room air and delivers it to a mechanical ventilator breathing circuit in a controlled concentration from 0.1 to 80 ppm NO. The attached nitric oxide delivery module (NDM) measures the gas flow in the ventilator breathing circuit and delivers a controlled flow of nitric oxide enriched gas into the breathing circuit. The device also incorporates a gas monitoring system (with user-set alarms) for measuring the gas concentrations of nitric oxide, nitrogen dioxide (NO2) and oxygen (O2) in the ventilator breathing circuit just prior to inhalation by the patient, via a sampling line.
The system is comprised of three sub-systems: The NO Generator with the NO2 Filter, the Nitric Oxide Backup and Bagging System, and the Gas Sampling and Monitoring System.
Beyond Air, Inc.
90002
In Commercial Distribution
- B882900020 ()
- Nitric oxide delivery unit, system-based
Nevisense measures electrical impedance of skin lesions and provides an output called the electrical impedance spectroscopy (EIS) score.
Electrical impedance is a measure of a material’s overall resistance to the flow of alternating electric currents of various frequencies.
The principle is that electrical impedance is different in normal versus abnormal tissue.
Scibase AB
511-0001
In Commercial Distribution
- 07350094440071 ()
511-0001
- Neoplasm electrical impedance spectrometer
The Carl Zeiss Meditec MEL 90 Excimer Laser System is designed for refractive surgery based on the ablation of corneal tissue achieved with a short pulse excimer laser having a wavelength of 193 nanometers. The laser head emits 4 to 7 nanosecond pulses (FWHM nominal pulse duration) with a repetition rate of 500 Hz. The MEL 90 Excimer Laser is a spot-scanning laser that utilizes a Gaussian beam with a 0.7 mm spot diameter.
Indications for Use:
The MEL 90 is indicated for use in primary Laser-Assisted in situ Keratomileusis (LASIK) treatments for the reduction or elimination of:
• Myopia less in magnitude than -10.00 D sphere (in minus-cylinder notation), with and without cylinder up to -4.00 D, when MRSE is less in magnitude than -10.00 D;
• Hyperopia up to +4.00 D sphere (in plus-cylinder notation), with and without cylinder up to +3.00 D, when MRSE is up to +5.00 D; and
• Mixed astigmatism with cylinder from >1.00 D up to 4.00 D;
in patients who are 18 years of age or older with documentation of stable manifest refraction over the past year as demonstrated by a change in MRSE within +/- 0.50 D.
Carl Zeiss Meditec AG
1900-109
In Commercial Distribution
- 04049471095074 ()
- Weight: 295 Kilogram
- x W x H: 1.63 m x 0.73 m x 1.48 m to 1.70 m
- Ophthalmic excimer laser system
ID CORE XT (Reagents and Analysis Software) is a qualitative, polymerase chain reaction (PCR) and hybridization-based genotyping test for the simultaneous identification of multiple alleles encoding human erythrocyte antigens (HEAs) in genomic DNA extracted from whole blood specimens collected in EDTA. This test can be used to genotype 29 polymorphisms and predict 37 HEA phenotypes of blood group systems Rh (CW, C, c, E, e, VS, V, hrB, hrS), Kell (K, k, Kpa, Kpb, Jsa, Jsb), Kidd (Jka, Jkb), Duffy (Fya, Fyb), MNS (M, N, S, s, U, Mia), Diego (Dia, Dib), Dombrock (Doa, Dob, Hy, Joa), Colton (Coa, Cob), Cartwright (Yta, Ytb), and Lutheran (Lua, Lub) as an alternative to serology.
The ID CORE XT test relies on allele-specific probes attached to color-coded microspheres, which hybridize specifically to the labeled PCR products. A subsequent fluorescent labeling step allows detection and quantification of the hybridization signal. ID CORE XT generates a simultaneous multiplex reaction in a single well, avoiding the need to run separate methods in parallel. The software outcome is a polymorphism genotype, a predicted allele genotype and a predicted phenotype, bypassing any subjective interpretation of the results.
PROGENIKA BIOPHARMA, SA
v3
In Commercial Distribution
- 08437013457019 ()
1021720000
- Multiple blood group genotyping IVD, nucleic acid technique (NAT)
The EndoForce™ Connector for Endovascular Venous Anastomosis (herein referred to as the EndoForce™ System) includes an implantable component, the EndoForce™ Connector and a delivery system, EndoForce™ Connector Delivery System. The EndoForce Connector™ is a venous anastomosis implant used in conjunction with a 6 mm inner diameter expanded polytetrafluoroethylene (ePTFE) arteriovenous graft (not provided). The graft is sutured to the artery using a conventional anastomosis. The graft, and not the EndoForce™ Connector, is to be used for vascular access during hemodialysis in patients with end stage renal disease. The EndoForce™ Connector is provided pre-loaded within the EndoForce™ Connector Delivery System.
Phraxis Inc.
EFORCE-100
In Commercial Distribution
- 00860014060601 ()
- Stent Length: 66 Millimeter
- Synthetic vascular graft
Preveleak Surgical sealant is a sealant developed to seal suture holes formed during surgical repair of the circulatory system and to reinforce sutured anastomoses.
Baxter Healthcare Corporation
ADS201810
Not in Commercial Distribution
- 25413765583609 ()
- 05413765583605 ()
ADS201810
- Surgical internal adhesive/sealant, animal-derived
Preveleak Surgical sealant is a sealant developed to seal suture holes formed during surgical repair of the circulatory system and to reinforce sutured anastomoses.
Baxter Healthcare Corporation
ADS201809
Not in Commercial Distribution
- 25413765583593 ()
- 05413765583599 ()
ADS201809
- Surgical internal adhesive/sealant, animal-derived
Preveleak Surgical sealant is a sealant developed to seal suture holes formed during surgical repair of the circulatory system and to reinforce sutured anastomoses
Baxter Healthcare Corporation
ADS201808
In Commercial Distribution
- 25413765583586 ()
- 05413765583582 ()
ADS201808
- Surgical internal adhesive/sealant, animal-derived
DQA phantom (tissue mimic) gel for calibration prior neuro MR-guided FUS treatment.
a part of 1.5T neuro kit (SET000937) and 3T neuro kit (SET000936)
INSIGHTEC LTD
NEURO DQA PHANTOM GEL
In Commercial Distribution
- 07290015461207 ()
SET000932
- Therapeutic oncological/gynaecological ultrasound system
The Inspire® Respiratory Sensing Lead (Model 4340) is designed to detect respiratory effort. The lead features a pressure sensitive membrane that converts the mechanical energy of respiration into an electrical signal. The lead incorporates a standard connector for coupling to the Inspire implantable pulse generator (IPG) for treatment of obstructive sleep apnea.
Inspire Medical Systems, Inc.
900-014-005
In Commercial Distribution
- 10810098650301 ()
4340
- Implantable sleep apnoea treatment system, respiration-sensing