ICU Medical, Inc.

데이터베이스에서 발견된 의료기기 1건 데이터베이스에서 발견된 의료기기 2 건

  • 모델명 / 제조번호(시리얼번호)
    Catalog # : Lot # B7825: 253026-SC, 253046-SC, 253069-SC, 253073-SC, 253081-SC, 253103, 253112, 253120, 253125, 253130, 253144, 253183, 253199, 253216, 253226,  253234, 253245, 253258, 253269, 253281, 253294, 253300, 253301, 253313, 253326, 253341, 253348, 253363. B7837: 233068-SC, 253037-SC, 253041-SC, 253049-SC, 253053-SC, 253057-SC, 253060-SC, 253064-SC, 253074-SC, 253080-SC, 253084-SC, 253087, 253088, 253097, 253100, 253104, 253109, 253113, 253121, 253126, 253133, 253136, 253140, 253146, 253149, 253152, 253159, 253168, 253171,  253177, 253181, 253187, 253188, 253190, 253194, 253196 253198, 253200,  253205, 253207, 253208, 253210, 253214, 253219, 253223, 253227, 253231, 253235, 253238, 253243, 253246, 253251, 253254, 253255, 253257, 253262,  253264, 253272, 253273, 253275, 253278, 253280, 253283, 253288, 253292, 253295, 253299, 253307, 253311, 253315, 253318, 253319, 253324-SC, 253328, 253331, 253336, 253338, 253342, 253350, 253351, 253356, 253358,  253366, 253370, 253372, 253374, 253381, 253384-SC, 253388, 253390, 253392, 253396, 253399, 253401, 253406, 253409, 253411, 253413, 253417, 253421, 253422, 253426, 253432, 253435, 253437, 253439, 253444, 253451, 253452, 253457, 253466, 253470, 253473, 253475, 253476, 253479, 253485, 253491, 253495, 253496, 253500, 253502, 253505, 253512, 253519, 857-SC4. B7841: 233163, 253028-SC, 253033-SC, 253052-SC, 253056-SC, 253065-SC, 253070-SC, 253078-SC, 253091, 253099, 253101, 253106, 253115, 253119, 253124, 253128, 253141, 253147, 253153, 253156, 253169, 253172, 253180, 253191, 253204, 253211, 253222, 253228, 253236, 253242, 253247,  253253, 253261, 253271, 253274, 253279, 253282, 253289, 253297, 253302, 253304, 253308, 253316, 253322, 253327, 253329, 253333, 253339, 253343, 253346, 253352, 253357, 253367, 253369, 253375 800 253379 , 253383-SC, 253391, 253397, 253402, 253410, 253414, 253418, 253420, 253425, 253430, 253438, 253440, 253453, 253455, 253458, 253468, 253469, 253477, 253480, 253486, 253492, 253504, 253506, 253511, 253515,  253521, 253530. B7842: 20600, 253036-SC, 253040-SC, 253062-SC, 253079-SC, 253107, 253116, 253142, 253157, 253166, 253175, 253192, 253195, 253212, 253224, 253240, 253249, 253276, 253286, 253305, 253320, 253332, 253344, 253364, 253376, 253380, 253385, 253407, 253415, 253423, 253436, 253441, 253459, 253462, 253481, 253487, 253493, 253503, 253535. B7844: 253047-SC. B7846: 253513. B7905: 2010928, 2010955, 2010956, 2026848, 2026849, 2026852, 2066860, 2010928, 2010955, 2010956, 2026848, 2026849, 2026852, 2066860, 2098782, 2145226, 253009-SC, 253035-SC, 253066-SC, 253089, 253123, 253139, 253160, 253178, 253197, 253213, 253241, 253265, 253285, 253303,, 253310, 253325, 253337, 253360, 253386, 253403, 253405, 253427, 253449, 253463, 857-SC1. B7928: 213167, 233061-SC, 253045-SC, 253055-SC, 253059-SC, 253077-SC, 253082-SC, 253086, 253093, 253095, 253102, 253111, 253118, 253129, 253137, 253145, 253151, 253158, 253173, 253176, 253186, 253193, 253201,  253206, 253209, 253218, 253220, 253230, 253232, 253239, 253248, 253252, 253256, 253260, 253268, 253277, 253287, 253291, 253296, 253306, 253312,  253317, 253323, 253330, 253334, 253340, 253345, 253349, 253353, 253359,  253368, 253371, 253382, 253389, 253393, 253398, 253404253408, 253416, 253424, 253429, 253433, 253442, 253448, 253454, 253460, 253464, 253471,  253478, 253483, 253488, 253494, 253497, 253501, 253507. B7932: 2010961, 2012567, 2012965, 2022800.  B7937: 253355, 253362, 253377, 253394.  B7938: 253354, 253361, 253378, 253395.  Z0125: 78-458-YJ.  Z8015: 59-941-SN, 61-164-LA, 61-898-LA, 62-799-R5, 63-307-YJ, 64-027-2A, 64-245-K4, 65-616-K4, 66-136-R5, 67-582-YJ, 67-803-2A, 69-758-R5, 70-155-K4, 71-538-LA, 73-027-YJ, 73-736-YJ, 74-402-K4, 74-962-R5, 76-203-2A, 77-360-R5, 80-869-R5, 80-957-K4, 85-657-LA, 88-569-2A, 89-613-SN, 92-782-R5, 94-196.2A, 94-196-2A  Z8017: 61-577-K4, 63-347-SN, 64-194-2A, 64-407-K4, 68-446-K4, 70-351-2A, 72-636-YJ, 73-735-YJ, 74-585-K4, 78-846-2A, 81-540-2A, 84-591-YJ, 86-016-SN, 89-540-LA, 91-210-LA, 92-295-YJ, 92-781-R5, 93-166-LA.  Z8028: 57-112-R5, 58-440-LA, 62-236-R5, 62-239-R5, 63-308-YJ, 64-028-2A, 65-333-LA, 65-617-K4, 66-352-R5.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution: USA (Nationwide) and countries of: Austria, Belgium, Chile, Cyprus, CZ, France, Germany, Great Britain, Greece, Israel, Italy, Lithuania, Netherland, Poland, Russia, Saudi Arabia, Sweden, and Switzerland.
  • 제품 설명
    IV Start Kits || Convenience kit for starting IVs. Triad wipes are packaged within the sterile barrier and would require compromising the barrier to replace the wipe.
  • 모델명 / 제조번호(시리얼번호)
    Catalog # Lot # B7905: 2010928, 2010955, 2010956, 2026848, 2026849, 2026852. B7932: 2010961, 2012567, 2012965, 2022800. M1861: 1724481 M2461: 1701070. M2491: 1706450. M3060: 1711976. M3091: 1701069. M4261: 1711981. P1005: 1992939. P1850: 1887213. P1851: 1646310, 1646311, 1750036, 1863485, 1887212, 1972548, 2013176. P1861: 1385494, 1711980, 1752814. P1881: 2027824. P1891: 1471913. P2450: 1800862. P2451: 1598200, 1598201, 1598206, 1750038, 1800860, 1815008, 1851423, 1887209, 1887216, 1972553. P2460: 1470415, 1722014. P2461: 1087509, 1385394, 1598097, 1774378, 1803640, 1848045, 1971554, 2022098. P2481: 1999027, 1999484, 2022794, 2027826. P2491: 1363050, 1557296, 1692396, 1782845. P3051: 1366012, 1646308, 1646312, 1660580, 1660581, 1800858, 1841693, 1853574, 1887208, 1887215, 1887217, 1972556, 2027827. P3061: 1062302, 1087495, 1686643. P3081: 1919294, 1972551, 1978024, 2027828. P3091: 1244139, 1244140, 1244141, 1363051, 1598101, 1598102, 1686641, 1686644. P4251: 1646309, 1646313, 1871643, 2022795. P4260: 1439395. P4261: 1363053, 1722015. P4281: 2027825, 2045107. P4290: 1439397. P4291: 1363049, 1722019, 1761743, 1774372, 1774374, 1774375, 1774376, 1774377, 1774379, 1774380, 1782841, 1782842, 1782843, 1782844, 1799794, 1799795, 1799796, 1799797, 1799798, 1814994, 1848046, 1855183, 1972546, 2007344, 2027816. P4291M: 1863467, 186468, 1863469, 18687998, 1887999, 1888000, 1888001, 1888002, 1888003, 1888004, 1888005, 1888006, 1972538, 1972539, 1972542, 1975233, 1990393, 1990395, 1991948, 2006952, 2006953, 2006954, 2006955, 2007432, 2022118, 2026307, 2026308, 2026309, 2027903, 2027904, 2028415.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution: USA (Nationwide) and countries of: Austria, Belgium, Chile, Cyprus, CZ, France, Germany, Great Britain, Greece, Israel, Italy, Lithuania, Netherland, Poland, Russia, Saudi Arabia, Sweden, and Switzerland.
  • 제품 설명
    Orbit and Orbit Micro || Subcutaneous infusion set Triad alcohol wipes are co-packaged with the Orbit devices. Our device is within its own separate sterile package and the wipes are packaged with our devices within an outer container. Removal of the wipes will not compromise the sterile barrier of our device and can easily be identified and replaced.

유사한 이름을 가진 의료기기 1건 유사한 이름을 가진 의료기기 3 건

데이터에 대해 더 자세히 알아보기 여기

  • 제조사 주소
    ICU Medical, Inc., 951 Calle Amanecer, San Clemente CA 92673-6212
  • 제조사 모회사 (2017)
  • Source
    USFDA