Devices

CDI 101

  • 모델명 / 제조번호(시리얼번호)
    1070-1839
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution, including USA, Australia, Barbados, BELGIUM, BRAZIL, CANADA, Chile, Colombia, Costa Rica, Dominican Republic, ECUADOR, El Salvador, France, Germany, Guatemala, Holland, Honduras, Hong Kong, India, Indonesia, Japan, Jordan, Korea, Libya, MALAYSIA, MEXICO, PAKISTAN, PANAMA, Paraguay, Saudi Arabia, SINGAPORE, South Africa, Spain, TAIWAN, THAILAND, The Phillipines, TRINIDAD, UNITED ARAB EMIRATES, Uruguay, Venezuela and Vietnam.
  • 제품 설명
    Terumo Cardiovascular Systems, CDI 101 Hematocrit/Oxygen saturation monitoring system, catalog 101.
  • 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

유사한 이름을 가진 의료기기 1건 유사한 이름을 가진 의료기기 5 건

데이터에 대해 더 자세히 알아보기 여기

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
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
CDI 101 BLOOD HCT/OXYGENATION- MONITOR
  • 모델명 / 제조번호(시리얼번호)
    Model Catalog: 101 (Lot serial: sn 1070 to 1697); Model Catalog: 100 (Lot serial: sn 100-001 to 100-1687)
  • 제품 설명
    CDI 101
  • Manufacturer
    RYAN MEDICAL DISTRIBUTORS INC.
CDI 101 BLOOD HCT/OXYGENATION- MONITOR
  • 모델명 / 제조번호(시리얼번호)
    Model Catalog: 101 (Lot serial: 1000 TO 5556)
  • 제품 설명
    CDI 101 BLOOD HCT/OXYGENATION- MONITOR
  • Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
Device Recall CDI 101
  • 모델명 / 제조번호(시리얼번호)
    CDI 101 1070-1697
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    US, India, Colombia, Taiwan, Venezuela, Vietnam, Puerto Rico, Malaysia, Sri Lanka, Brazil, Indonesia, Pakistan, Chile, Germany, Hong Kong, Japan, AE, Singapore, Austria, Belgium and Thailand.
  • 제품 설명
    Terumo Cardiovascular Systems Corporations, CDI 101 Hematocrit/Oxygen Saturation Monitoring System. In-line blood-gas sensor used in cardiopulmonary bypass.
  • Manufacturer
    Terumo Cardiovascular Systems Corporation