Devices

Device Recall CDI 101 Hematocrit/Oxygen Saturation Monitoring System

  • 모델명 / 제조번호(시리얼번호)
    Catalog number: 101 and Serial Numbers: 0503, 1000, 1017, 1070, 1071, 1073, 1074, 1076, 1077, 1080, 1082, 1083, 1107-1110, 1115-1117,1124,1126-1134, 1136, 1137, 1139-1146, 1148-1152, 1154-1156, 1159-1162, 1164-1166, 1168-1177, 1182, 1185-1190, 1192,1193, 1195, 1197, 1198, 1225, 1228, 1229, 1237, 1239-1241,1243-1245,1247, 1249-1326, 1332-1339, 1344-1347, 1349, 1350-1363, 1365-1409, 1411-1436,1438, 1440-1447, 1449-1453, 1455-1463,1465-1482,1484-1492,1494-1552,1555-1565, 1567-1600,1602,1605-1607,1609-1611,1613-1623,1625-1629,1632-1651,1653, 1655-1660, 1662-1664, 1666, 1667,1669-1679,1681-1684,1686,1689-1691, 1693-1710,1712-1715,1717-1750,1752-1757,1759-1771,1773-1785,1787,1788,1790-1809, 1811-1831,1833,1838,1839,1855-1858,1866, and TK001-TK011.
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution.
  • 제품 설명
    Terumo CDI 101 Hematocrit/Oxygen Saturation Monitoring System. Monitors blood/oxygen saturation, hematocrit and hemoglobin levels.
  • Manufacturer
    Terumo Cardiovascular Systems Corporation
  • 1 Event

제조사

Terumo Cardiovascular Systems Corporation
  • 제조사 주소
    Terumo Cardiovascular Systems Corporation, 6200 Jackson Road, Ann Arbor MI 48103-9586
  • 제조사 모회사 (2017)
    Terumo Corp.
  • Source
    USFDA

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Device Recall CDI 101 Hematocrit/Oxygen Saturation Monitoring System
  • 모델명 / 제조번호(시리얼번호)
    Catalog number :101; Serial Numbers: 1070, 1071, 1076, 1077, 1080, 1083, 1104, 1107, 1108, 1115-1117, 1124, 1127, 1128, 1132-1134, 1136, 1137, 1139-1144, 1148, 1151, 1152, 1154-1156, 1160-1162, 1166, 1168-1173, 1182,1185,1186,1190,1192, 1193, 1195, 1239-1241, 1243-1245, 1247, 1249-1257,1261, 1264-1266, 1268-1277,1279, 1280, 1282-1289, 1297,1299-1301, 1306-1311, 1313-1318, 1321-1324, 1337-1339, 1350-1355, 1357-1363, 1365-1377, 1382, 1386, 1406-1409, 1411, 1413,1414, 1417-1422, 1428-1436, 1440, 1441, 1443-1447, 1450-1453, 1455-1458, 1460, 1463, 1469-1482, 1484, 1486, 1488, 1492,1503-1511 ,1513, 1515-1520, 1532-1534, 1537, 1540, 1542, 1543, 1547, 1548, 1550, 1551, 1555, 1560-1563, 1568-1574, 1578, 1579, 1585-1596, 1598, 1614, 1615, 1617-1622, 1625-1629, 1632-1647, 1653, 1655, 1660, 1666, 1667, 1669-1676, 1679, 1681, 1682, 1690, 1693, 1694, 1696, 1699, 1705-1709, 1713, 1714, 1726, 1729-1734,1738, 1745-1750,1752-1756,1760, 1764-1768, 1771, 1773-1777,1785,1787,1788,1790-1794,1797-1799,1801-1808,1816,1818-1821, 1823, 1826, and 1839.
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution - Including the states of: NV, MO, SC, WA, MI, FL, GA, NY, CT, IL, VA, NY, TN, IN, HI, TX, AL, OH, MD, AZ, CA, KS, MD, PA, and NM.
  • 제품 설명
    CDI 101 Hematocrit/Oxygen Saturation Monitoring System. The CDI 101 Hematocrit/Oxygen Saturation Monitoring System is intended for use during cardiopulmonary bypass procedures where continuous monitoring of the blood's oxygen saturation, hematocrit and hemoglobin levels is needed.
  • Manufacturer
    Terumo Cardiovascular Systems Corporation