Device Recall Pulse Oximeter

  • 모델명 / 제조번호(시리얼번호)
    Catalog Number 9190 9193 9191 9192 9212 9213 9218 9219 9224 9282 9285 2883 9194
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA (nationwide) including the countries of Africa, Asia, Australia/New Zealand, Europe, Canada, Latin America, and Middle East / SW Asia.
  • 제품 설명
    Rad-8 Pulse Oximeters || The Rad-8 family of pulse oximeters and accessories are indicated for the continuous, noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor).
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Masimo Corporation, Forty Parker, Irvine CA 92618
  • 제조사 모회사 (2017)
  • Source
    USFDA

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  • 모델명 / 제조번호(시리얼번호)
    Device Listing Numbers: D111075, E448552, E448553, D111073, E653295  Catalog Numbers and Description: 2468-Rainbow 4D DC Sensor, 10 Spot Checks, US, 1/Box, Masimo, 2468-OU-Rainbow 4D DC Sensor, 10 Spot Checks, International, 1/Box, Masimo, 2482-4D DC Sensor, 500 Spot Checks, US, Refurbished, 1/Box, Masimo, 2920-4D DC Sensor, US, 1/Box, Masimo, 2920-OU-4D DC Sensor, International, 1/Box, Masimo, 2952-4D DC Sensor, 360 Spot Checks, US, 1/Box, Masimo, 2952-OU-4D DC Sensor, 360 Spot Checks, International, 1/Box, Masimo, 2953-4D DC Sensor, 500 Spot Checks, US, 1/Box, Masimo, 2953-OU-4D DC Sensor, 500 Spot Checks, International, 1/Box, Masimo, 2954-4D DC Sensor, 1000 Spot Checks, US, 1/Box, Masimo, 2954-OU-4D DC Sensor, 1000 Spot Checks, International, 1/Box, Masimo, 9147-4D DC Sensor, 1-10,000 Spot Checks, US, 1/Box, Masimo, 9147-OU-4D DC Sensor, 1-10,000 Spot Checks, International, 1/Box, Masimo
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - Nationwide in the US and worldwide to Argentina, Austria, Bahrain, Belgium, Benin, Canada, Chile, China, Costa Rica, Croatia, Czech Republic, Egypt, Finland, France, Germany, Ghana, Greece, Hong Kong, Hungary, India, Indonesia, Iraq, Ireland, Israel, Jordan, Kazakhstan, Kenya, Kuwait, Latvia, Lebaron, Libyan Arab, Jamahiriya, Malaysia, Malta, Mauritius, Morocco, Netherlands, New Zealand, Norway, Oman, Philippines, Poland, Portugal, Reunion, Romania, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, United Arab Emirates, United kingdom
  • 제품 설명
    Masimo Hemoglobin || Pronto-7 with Rainbow 40 Technology for || easy-to-use spot-check testing of hemoglobin (SpHb), || SpO2, pulse rate, and perfusion index || Pronto-7 rainbow 4D Reusable Sensors are an accessory to the Masimo Rainbow SET Pronto-7 Pulse CO-Oximeter. The Masimo Rainbow SET Pronto-7 Pulse CO-Oximeter (instrument) with Masimo Rainbow SET Technology is developed to simultaneously and non-invasively measure functional arterial oxygen saturation (SpO2), pulse rate (PR), total hemoglobin (SpHb) and perfusion index (PI). The instrument has a single on/off button and an interactive touchscreen for administering tests along with user selectable options.
  • Manufacturer