Device Recall Ultraview SL Capnography Module

  • 모델명 / 제조번호(시리얼번호)
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution--USA (nationwide) and countries of ALGERIA, ARGENTINA, AUSTRALIA, BAHRAIN, BANGLADESH, BELGIUM, BOLIVIA, BRAZIL, CANADA, CHILE, CHINA,COLOMBIA, CYPRUS, CZECH REPUBLIC, DOMINICAN REPUBLIC, ECUADOR, EGYPT, ESTONIA, FRANCE, GERMANY, GREECE, GUATEMALA, HONG KONG, INDIA, ISRAEL, ITALY, JORDAN, KUWAIT, LEBANON, MALAYSIA, MEXICO, MOROCCO, NEPAL, NETHERLANDS, NEW ZEALAND, NORWAY, PAKISTAN, PALESTINE, PANAMA, PERU, POLAND, PORTUGAL, ROMANIA, SAUDI ARABIA, SINGAPORE, SLOVAKIA, SOUTH AFRICA, SPAIN, SRI LANKA, SWEDEN, SWITZERLAND, SYRIAN ARAB REPUBLIC, TAIWAN, REPUBLIC OF CHINA, TRINIDAD AND TOBAGO, TUNISIA, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, VENEZUELA, and VIET NAM.
  • 제품 설명
    The Ultraview SL 91517 Capnography module is a mainstream and sidestream gas analyzer designed to measure the concentration of carbon dioxide in a gas mixture, to aid in determining the patient's ventilatory, circulatory, and metabolic status. || Mainstream monitoring uses a self-calibrating CO2 sensor to ensure continuous monitoring without interruption of connection. Reusable, lightweight (<14 grams), or single-use airway adapters are available for both adult and neonatal (low dead space) patients. || Respiration can be monitored via an airway adapter and endotracheal or tracheostomy tubes using the mainstream function of the module. || The intended use statement that apply to the 91517 are continuous monitoring of carbon dioxide and oxygen. The Model 95000-A Bedside/Transport Monitor is used at the patient's bedside to actively acquire, analyze, monitor and display a variety of clinical parameters (in clinically relevant formats) for adults, pediatric or neonatal patients. The Model 95000-A Bedside/Transport Monitor is designed for use by a healthcare professional in a hospital, healthcare facility (i.e., clinic), or intra-hospital transport. This product is not designed for home use or for use in transport vehicles.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Spacelabs Healthcare, Llc, 5150 220th Ave Se, Issaquah WA 98029-6834
  • 제조사 모회사 (2017)
  • Source
    USFDA

유사한 이름을 가진 의료기기 1건 유사한 이름을 가진 의료기기 1 건

데이터에 대해 더 자세히 알아보기 여기

  • 모델명 / 제조번호(시리얼번호)
    Model 91517 Lot BMP007559
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    8 units shipped to France, 1 unit to Brussels, Belgium, and 2 units to a medical center in WY.
  • 제품 설명
    Ultraview SL Capnography Module, Model 91517 || A mainstream and sidestream gas analyzer designed to measure the concentration of carbon dioxide in a gas mixture, to aid in determining the patient''s ventilatory, circulatory, and metabolic status.
  • Manufacturer