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BIOLIS 50i Superior is discrete photometric clinical chemistry analyzer. The device is intended to duplicate manual analytical procedures by automating various steps such as pipetting, heating, measuring color intensity, and reporting results. The device is intended to be used with certain materials to measure various analytes of diagnostic interest including glucose. An optional Ion Selective Electrode Module is intended to measure sodium, potassium and chloride.
BIOLIS 50i Superior with glucose hexokinase assay are intended to measure glucose quantitatively in human serum. Additionally, BIOLIS 50i Superior with Ion-Selective Elective modules additionally measure the concentration of the electrolytes, sodium, potassium and chloride in serum, using indirect potentiometry.
TOKYO BOEKI MEDISYS INC.
50-01-0000
Not in Commercial Distribution
- 04580262040014 ()
50-01-0000
- Multiple clinical chemistry analyser IVD, laboratory
Biolis 24i Premium is discrete photometric clinical chemistry analyzer. The device is intended to duplicate manual analytical procedures by automating various steps such as pipetting, heating, measuring color intensity, and reporting results. The device is intended to be used with certain materials to measure various analytes of diagnostic interest including glucose. An optional Ion Selective Electrode Module is intended to measure sodium, potassium and chloride.
Biolis 24i Premium with glucose hexokinase assay are intended to measure glucose quantitatively in human serum. Additionally, Biolis 24i Premium with Ion-Selective Elective modules additionally measure the concentration of the electrolytes, sodium, potassium and chloride in serum, using indirect potentiometry.
TOKYO BOEKI MEDISYS INC.
23-01-0000
Not in Commercial Distribution
- 04580262020016 ()
23-01-0000
- Multiple clinical chemistry analyser IVD, laboratory
RevLight is a device that utilizes Light Emitting Diodes to provide LED light to the body. The base unit contains the power supplies, the control unit, and sets of Pulsators that deliver the light to the skin. The output of the Pulsators ranges from 420-940nm. RevLight is intended for use to provide LED light to the body. Depending on the wavelength(s) of light delivered by the Pulsators, RevLight is:
1. generally indicated to treat dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris (Blue Pulsators); and
2. generally indicated to provide topical heating to promote increased blood flow, relaxation of muscle and relief of pain (Amber/Red Pulsators).
SUBCON MANUFACTURING CORP
1030
Not in Commercial Distribution
- B82110300 ()
1030
- Cosmetic red-light phototherapy system, professional
RevLight is a device that utilizes Light Emitting Diodes to provide LED light to the body. The base unit contains the power supplies, the control unit, and sets of Pulsators that deliver the light to the skin. The output of the Pulsators ranges from 420-940nm. RevLight is intended for use to provide LED light to the body. Depending on the wavelength(s) of light delivered by the Pulsators, RevLight is:
1. generally indicated to treat dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris (Blue Pulsators); and
2. generally indicated to provide topical heating to promote increased blood flow, relaxation of muscle and relief of pain (Amber/Red Pulsators).
SUBCON MANUFACTURING CORP
1000
Not in Commercial Distribution
- B82110000 ()
1000
- Cosmetic red-light phototherapy system, professional
The lnMode RF System generating RF energy with integral temperature and impedance feedback mechanism for procedures requiring electrocoagulation/contraction of soft tissue and hemostasis. The InMode RF System constantly monitors the temperature and impedance of the target treatment tissue, automatically adjusting energy delivery to maintain effective and safe tissue heating.
The lnMode RF System consists of an AC/DC power supply unit, RF generator, controller and user interface including touch screen. The RF handpiece is connected to the console via a cable and a foot switch activates the energy delivery to the hand piece. The handpiece is comprised of a disposable, single use plastic handle with internal and external electrodes.
INMODE M.D LTD
AG604881A
In Commercial Distribution
- 07290016633368 ()
AG606972A
- Multi-modality skin surface treatment system
The Geri Embryo Incubator is a benchtop incubator with six modular incubation chambers each with its own temperature control capability and separate gas inlet feed. Each chamber contains heating elements in its lid and base, together with an orange light source (591 nm) and camera with integrated optics that
take time-lapse images of embryos and allows operators to view embryos without removing them from the incubation chamber. Inside each chamber is a filter used to filter the gas mixture entering the incubation chamber from the gas supply. The gas is supplied from standard premixed medical gas cylinders.
The Geri Embryo Incubator includes firmware to control the incubator settings, and software to control patient information and settings.
GENEA BIOMEDX PTY LTD
GERI-INS-01
In Commercial Distribution
- 09348265003000 ()
- Assisted reproduction heater/incubator
The LaserShot M is a static laser system where the embryo is moved to the laser by moving the stage of the microscope. The LaserShot M components include a laser module (1.48 microm infrared diode laser, class 1M), laser adapter to connect to the microscope, mirror block, laser objective (25 times), USB camera, Eye Ware Software, and an optional target pointer and foot switch. The EyeWare software controls the device components, operates the laser, and takes images and records videos of embryo undergoing laser procedures. The software determines how many holes are drilled along this line and controls/restricts laser firing parameters to minimize localized heating of the embryo during these procedures. These laser devices have been designed to be fitted to compatible inverted microscopes.
Octax Microscience GmbH
19310/0148M
In Commercial Distribution
- 04260604170011 ()
19310/0148M
- Assisted reproduction laser system
RevLight is a device that utilizes Light Emitting Diodes to provide LED light to the body. The base unit contains the power supplies and the control unit. Attachable to the base unit are three sets of Pulsators that deliver the light to the skin as they are moved over the skin surface. The output of the Pulsators ranges from 420-940nm. RevLight is intended for use to provide LED light to the body. Depending on the wavelength(s) of light delivered by the detachable Pulsators that are connected to the base unit, RevLight is:
1. generally indicated to treat dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris (Blue Pulsators); and
2. generally indicated to provide topical heating to promote increased blood flow, relaxation of muscle and relief of pain (Amber/Red Pulsators).
SUBCON MANUFACTURING CORP
1029
Not in Commercial Distribution
- B82110290 ()
1029
- Cosmetic red-light phototherapy system, professional
Additional heating unit for AquaA water purification system.
AquaHT for:
AquaA 900H & AquaHT
AquaA 1800H & AquaA2 900H & AquaHT
AquaA 1800H & AquaHT
AquaA 1800H & AquaA2 1800H & AquaHT
AquaA 2700H & AquaHT
AquaA 2700H & AquaA2 2700H & AquaHT
AquaA 3600H & AquaHT
AquaA 3600H & AquaA2 3600H & AquaHT
The AquaA water purification system is a modular reverse osmosis unit intended for use with hemodialysis systems to remove organic and inorganic substances and microbial contaminants from the water used for treating hemodialysis patients or related therapies. This device is intended to be a component in a complete water purification system and is not a complete water treatment system.
The reverse osmosis unit must be preceded by pre-treatment devices and may need to be followed by post-treatment devices as well, to meet current AAMI/ANSI/ISO and Federal (U.S.) standards.
VIVONIC GmbH
AquaHT
In Commercial Distribution
- 04251285200470 ()
- Reverse-osmosis water purification system
The Reference Viscosity Oil QC test is a simple means of verifying proper operation of the Sonoclot Analyzer.
This test consists of a two point verification of the electromechanical oscillator and also ensures that the heating control is operating accurately. The two verification points are: 1) Probe-In-Air, and 2) Probe-In-Oil. The Probe-In-Air is the response of the electromechanical oscillator to air. The Probe-In-Oil is the response of the electromechanical oscillator to the reference viscosity liquid. Since the viscosity of the reference viscosity fluid is significantly temperature dependent, the Probe-In-Oil test point also verifies the temperature regulation.
The QC test should be run each day the Sonoclot Analyzer is used or as required by your institution.
Each Reference Viscosity Quality Control Kit contains 24 cuvettes, 24 probes, 1 vial of reference viscosity oil with end cap, and these instructions. These supplies provide 24 QC tests for the analyzer.
SIENCO, INC.
900-1302
In Commercial Distribution
- B55890013020 ()
- B55890013021 ()
900-1302
- Multiple coagulation factor IVD, control