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510(k) Data Aggregation
K Number
K103735Device Name
MEDILED MINI
Manufacturer
MEDIX I.C.S.A.
Date Cleared
2011-08-15
(236 days)
Product Code
LBI
Regulation Number
880.5700Why did this record match?
Applicant Name (Manufacturer) :
MEDIX I.C.S.A.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Medix MediLEDmini Phototherapy Lamp is intended for the treatment of neonatal hyperbilirubinemia. The device can be used with infants in a bassinet, incubator, open bed or radiant warmer. It emits a narrow band of blue light considered to be the most effective in the degradation of bilirubin.
Device Description
Medil EDmini is a LED Phototherapy lamp for neonatal use. It was specially crafted and designed to be used with incubators. Its small form size allows for great versatility without compromising powér, since it is one of the most powerful units in the market. LED technology is so advanced that its cold light avoids overheating in patients since it does not emit IR or UV radiation. Its high power and therapeutic efficacy reduces treatment costs, allowing the patient to be discharged in less time than with conventional phototherapy. lts small size and versatility is very useful in small environments and where space is a priority. The unit has 3 light intensities to choose: high-medium-low in order to answer different treatment needs
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K Number
K083179Device Name
MEDILED PHOTOTHERAPY LAMP
Manufacturer
MEDIX I.C.S.A.
Date Cleared
2009-02-27
(122 days)
Product Code
LBI
Regulation Number
880.5700Why did this record match?
Applicant Name (Manufacturer) :
MEDIX I.C.S.A.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
INDICATIONS FOR USE: The MediLED Phototherapy Lamp is intended for the treatment for neonatal hyperbilirubinemia. The device is intended for use by healthcare professionals in a clinical setting.
Device Description
The Medix MediLED is neonatal phototherapy equipment with blue and white LEDs, incorporating height and angle adjustments. The device is labeled and indicated for: treatment for neonatal hyperbilirubinemia. The device is intended for use in healthcare professionals in a clinical setting.
Fitted with a rolling base with brakes, column, and mobile head containing the equipment's electronics. The design allows the equipment to be used with incubators, infant warmers or cradles of all type and brand.
Features:
- Microprocessor mobile phototherapy equipment. (mobile stand with brakes) .
- Ideal for use in incubators, cribs and infant warmers .
- High brightness LED technology: led quantity 492 Blues ,108 whites. .
- Total Hour meter (LED useful life) and partial time (treatment). .
- Technical Service Indicator. .
- Examination light. .
- It is possible to maneuver with all LEDs on. .
- Continuous height shift by means of an actuator .
- Headlight positioning without the use of a tool .
Commands are found on the front of the equipment's head, consisting of three keys, two of which allow to operate separately blue from white LEDs, making it possible to check the patient's real skin color or perform interventions under white light. By turning on the blue LEDs, total and treatment counters are enabled. These indicate the total and treatment time of the phototherapy unit. The third key (reset) is used to restore the treatment counter. It also has two indicators; a green one showing the equipment is connected to the power supply and ready to be used, and a yellow one indicating the need of technical service assistance.
Blue LEDs do not emit significant ultraviolet (UV) neither infrared (IR) energy, resulting in no risk of UV, IR exposure nor excessive warming up for the patient.
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K Number
K070291Device Name
MEDIX NATAL CARE INTENSIVE CARE INCUBATOR, MODELS-NATAL CARE ST-MX/LX/BX
Manufacturer
MEDIX I.C.S.A.
Date Cleared
2007-09-21
(234 days)
Product Code
FMZ
Regulation Number
880.5400Why did this record match?
Applicant Name (Manufacturer) :
MEDIX I.C.S.A.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Medix Natal Care ST-MX/LX/BX Intensive Care Incubator provides a controlled thermal environment for neonates who are unable to provide their own thermoregulation. The Medix Natal Care ST-MX/LX/BX Intensive Care Incubator can be used in two operating modes: Air Control Mode and Skin Control Mode with two probes that can be used with twins or for a follow up of central/peripheral temperature variations in a patient as a tool for the early detection of thermal stress-effect on the newborn.
Device Description
The NATAL CARE ST-MX/LX/BX incubator is a new updated line of intensive care incubators with skin and air microprocessor temperature control. incorporating the latest technical and design advances for neonatal care.
The distinctive features of an intensive care incubator are offered: together with large displays showing skin and air temperature, with their respective control temperatures. A graphic display (electroluminescent or LCD) allows the selection of a conflagration options menu, and checks modular accessories that are optionally incorporated (pulse oximetry, humidity servo control, oxygen servo control, weighing scales).
NATAL CARE ST-MX/LX/BX incubator is comprised of three main elements: the clear hood, shell and stand. Together they measure H 53 in X W 41.3 in X D 23.5 in.
Two skin temperature probes are incorporated, allowing its use with twins or for a follow up of central/peripheral temperature variations in a patient as a tool for the early detection of thermal stress- effect on the newborn.
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