Devices

Medtronic Disposable Pressure Display Set

  • 모델명 / 제조번호(시리얼번호)
    Models 0K57R2, 0K82R15, 0M63R7, 0M68R6, 0N41R14, 0T50R5, 0V67R27, 0X52R3, 0Y35R, 0Y95R30, 0Z30R11, 1D41R16, 1F66R12, 1G59R1, 1J74R4, 1M90R8, 1P09R2, 2031R7, 2C88R8, 2C89R7, 2C90R7, 2C91R5, 2D61R2, 2D64R16, 2H08R3, 2K85R1, 2K87R1, 2K88R1, 2N90R9, 2T28R1, 3B74R2, 3T73R1, 3W29R, 4B42R5, 4C03R, 4D82R3, 4M55R, 4N04R, 4R43R, 5788R4, 5A45R3, 5B51R9, 5B94R, 5C33R2, 5C45R3, 5C92R9, 5D83R2, 5F68R1, 5G28R4, 5H65R, 5J00R2, 5P62R, 5W13R6, 5Z18R, 6G05R, 6J55R1, 6J88R4, 6J95R8, 6N12R, 6Q49R1, 6Q49R1, 6R08R, 6R09R, 6R44R2, 6S66R, 6S75R1, 6V25R, 6Y04R5, 6Y07R6, 6Y59R3, 7A69R4, 7A70R1, 7B56R1, CB0L44R16, CB0M02R5, CB0M79R8, CB1Q18R11, CB1S33R9, CB2D32R5, CB2W45R7, CB2W86R4, CB3K45R9, CB3K91R1, CB3M40R17, CB3Y46R9, CB3Y47R10, CB4800R18, CB4953R16, CB4958R16, CB4B68R8, CB4E78R7, CB4F45R15, CB4K64R6, CB4L83R4, CB4M60R2, CB4S43R9, CB4W10R10, CB4X84R, CB4Y71R14, CB4Z87R6, CB5A30R10, CB5F84R12, CB5J33R6, CB5L15R13, CB5L79R, CB5L90R16, CB5Q71R2, CB5Q74R1, CB5R04R1, CB5R46R5, CB5U81R, CB6A80R6, CB6G02R4, CB6H12R, CB6H45R4, CB6H76R, CB6H77R, CB6H78R, CB6J66R2, CB6J68R3, CB6J75R3, CB6L12R3, CB6L13R, CB6L14R, CB6L60R2, CB6M11R1, CB6Q15R, CB6Q16R1, CB6Q62R, CB6Q78R2, CB6S17R, CB6U12R, CB6U76R1, CB6X94R2, CB6X98R3, CB6Y02R6, CB6Y34R2, CB7C31R, DLP2X17R, HY0F32R17, HY2280R16, HY2U14R2, HY3U59R12, HY4A96R9, HY4V52R4, HY4V82R3, HY5D07R2, HY6B26R2, HY6G55R6, HY6G56R6, HY6H03R5, HY6H03R5, HY6J33R3, HY6J99R, HY6R36R1, HY6R36R1, HY6U70R2, HY6V34R2, HY6Z04R1, M331105H, M331105K, M336902L, M392810D, M392810E, M392811C, M392811D, M392811E, M440115G, M440115H, M440115J, M440115K, M440115L, M440129A, M440130A, M441002E, M443824F, M443825E, M492609A, M499301B, M530710A, M530710C, M530710D, M960208A, M960454B, P390806A, S330115A, SS6X67R1, SS6Z09R1, SSHY6E81R2, TL2H89R7, TL3Y45R1, TL3Z67R4, TL4E64R, TL4E66R10, TL4E66R10, TL5398R21, TL5C09R4, TL5M01R7, TL5R15R4, TL6A91R2, TL6C91R2, TL6D87R2, TL6H39R5, TL6W08R3, TL6X29R4, TL6X36R2, TL6X62R5, TL6Y92R, TL7A15R2.
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA (nationwide) including Puerto Rico, and Virgin Islands (U.S.) and the countries of: Argentina, Australia, Austria, Belarus, Belgium, Bulgaria, Canada, Chile, China, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, El Salvador, France, Georgia, Germany, Greece, Hong Kong, Hungary, Iceland, India, Indonesia, Israel, Italy, Jamaica, Japan, Korea, Kuwait, Latvia, Lebanon, Libya, Malaysia, Netherlands, New Zealand, Nicaragua, Norway, Pakistan, Poland, Portugal, Romania, Saudi Arabia, Singapore, Slovenia, Spain, Sweden, Switzerland, Taiwan, United Arab Emirates, United Kingdom, Venezuela, and Yemen.
  • 제품 설명
    Medtronic Intersept Custom Tubing Pack, which are designed as specified by the user. The following models contain a Pressure Display Set. Sterilized by Ethylene Oxide. Non-pyrogenic. Manufacturer: Medtronic, Inc. 710 Medtronic Parkway, Minneapolis, MN 55432-5604. || Product Usage: This product is intended for use in monitoring catheter, cannula, or line pressures associated with cardiopulmonary bypass equipment and/or related products.
  • Manufacturer
    Medtronic Perfusion Systems
  • 1 Event

제조사

Medtronic Perfusion Systems
  • 제조사 주소
    Medtronic Perfusion Systems, 7611 Northland Dr N, Brooklyn Park MN 55428-1088
  • 제조사 모회사 (2017)
    Medtronic plc
  • 제조사 의견
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    USFDA

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

데이터에 대해 더 자세히 알아보기 여기

Medtronic Disposable Pressure Display Set
  • 모델명 / 제조번호(시리얼번호)
    Lot numbers: 2008070788, 2008070792, 2008070793, 2008070955, 2008080357, 2008080359, 2008080385, 2008080426, 2008080441, 2008080525, 2008080545, 2008081109, 2008081195, 2008090080, 2008090244, 2008090980, 2008091122, 2008091123, 2008091125, 2008100001, 2008100531, 2008100583, 2008100605, 2008100607, 2008101323, 2008101324, 2008101325, 2008101368, 2008101375, 2008101379, 2008101380, 2008110008, 2008110173, 2008110287, 2008110301, 2008110530, 2008110531, 2008110612, 2008110720, 2008110876, 2008110877, 2008110878, 2008111157, 2008111209, 2008111210, 2008120149, 2008120150, 2008120478, 2008120848, 2008120849, 2008120850, 2008120851, 2008121107, 2009010121, 2009010122, 2009010603, 2009010604, 2009010605, 2009010953, 2009010954, 2009010955, 2009011280, 2009011281, 2009011282, 2009011283, 2009011284, 2009020119, 2009020581, 2009020841, 2009020842, 2009020843, 2009030102, 2009030327, 2009030328, 2009030329, 2009030330, 2009030626, 2009030955, 2009031171, 2009031172, 2009040538, 2009040539, 2009040540, 2009040541, 2009040834, 2009041092, 2009041093, 2009041094, 2009050183, 2009050527, 2009050528, 2009050529, 2009050867, 2009050868, 2009050975, 2009050976, 2009060054, 2009060381, 2009060382, 2009060383, 2009060633, 2009060640, 2009060641, 2009060642, 2009060696, 2009061139, 2009070210, 2009070487, 2009070488, 2009070912, 2009071231, 2009080403, 2009080404, 2009080405, 2009080406, 2009080407, 2009081128, 2009081129, 2009081130, 2009081131, 2009081851, 2009090137, 2009090589, 2009090590, 2009090591, 2009091085, 2009100116, 2009100118, 2009100443, 2009100444, 2009100445, 2009100446, 2009100882, 2009100974, 2009100975, 2009100976, 2009100977, 2009100978, 2009101597, 2009101598, 2009102220, 2009102221, 2009102222, 2009110186, 2009110859, 2009110861, 2009111388, 2009112071, 2009120316, 2009120317, 2009120788, 2009120789, 2009120790, 2009120791, 2009121304, 2009121305, 2009121306, 2009121701, 2009121704, 2010010236, 2010010237, 2010010238, 2010011329, 2010011330, 2010011525, 2010011526, 2010011527, 2010021286, 2010022073, 2010022074, 2010031328, 2010031329, 2010031330, 2010031331, 2010031332, 2010031333, 2010032084, 2010032085, 2010032086, 2010032087, 2010032816, 2010032817, 2010032818, 2010032819, 2010032820, 2010033477, 2010033478, 2010033479, 2010040563, 2010040564, 2010040947, 2010040948, 2010040949, 2010041433, 2010050370, 2010050371, 2010050726, 2010050963, 2010051276, 2010051363, 2010060108, 2010060280, 2010060558, 2010060689, 2010061703, 2010061759, 2010062023, 2010062558, 2010062870, 2010062871, 2010070115, 2010071372, 2010071373, 2010071375, 2010071377, 2010071570, 2010071868, 2010080229, 2010080231, 2010080810, 2010080811, 2010080812, 2010081270, 2010081424, 2010081602, 2010081604, 2010081606, 2010082011, 2010082012, 2010082218, 2010082219, 2010082439, 2010090223, 2010090420, 2010090497, 2010090615, 2010090759, 2010090939, 2010090952, 2010091040, 2010091666, 2010091802, 2010092208, 2010092209, 2010092472, 2010092505, 2010100038, 2010100237, 2010100249, 2010100374, 2010100376, 2010100681, 2010101291, 2010101293, 2010101374, 2010101385, 2010101493, 2010101961, 2010101974, 2010110030, 2010110033, 2010110974, 2010120220, 2010120424, 2010120605, 2010120606, 2010121586, 2010121587, 2010122170, 2010122208, 2011010069, 2011010367, 2011010368, 2011011063, 2011011067, 2011011311, 2011011454, 2011011931, 2011020018, 2011020019, 2011020217, 2011020218, 2011020581, 2011020583, 2011020585, 2011020955, 2011020956, 2011021012, 2011021014, 2011021155, 2011021156, 2011021157, 2011021668, 2011021669, 2011021991, 2011021993, 2011022187, 2011022188, 2011030015, 2011030089, 2011030090, 2011030095, 2011030155, 2011030156, 2011030311, 2011030312, 2011031091, 2011031094, 2011031450, 2011031610, 2011031611, 2011031685, 2011032335, 2011032336, 2011040004, 2011040025, 2011040026, 2011040260, 2011040261, 2011040365, 2011040366, 2011040811, 2011040812, 2011041038, 2011041070, 2011041092, 2011041194, 2011041306, 2011041307, 2011041573, 2011041574, 2011041590, 2011041592, 2011050006, 2011050362, 2011050363, 2011050397, 2011050398, 2011050657, 2011050697, 2011051009, 2011051238, 2011051239, 2011051381, 2011051382, 2011051696, 2011051704, 2011060013, 2011060014, 2011060184, 2011060373, 2011060375, 2011060551, 2011060680, 2011060726, 2011060786, 2011061269, 2011061271, 2011062118, 2011062119, 2011062400, 2011062401, 2011062402, 2011070035, 2011070036, 2011070285, 2011070287, 2011070847, 2011070848, 200806C084, 200806C089, 200808C026, 200808C094, 200808C109, 200811C004, 200811C005, 200811C038, 200812C005, 200903C075, 200905C126, 200908C163, 200908C164, 200910C047, 200910C175, 200910C182, 200910C183, 200911C085, 200912C010, 201001C087, 201002C045, 201002C135, 201005C040, 201006C018, 201007C033, 201008C040, 201009C132, 201009C180, 201009C181, 201011C104, 201011C132, 201011C139, 201012C042, 201101C032, 201102C103, 201103C061, 201104C019, 201104C064, 201104C106, 201105C057.
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA (nationwide) including Puerto Rico, and Virgin Islands (U.S.) and the countries of: Argentina, Australia, Austria, Belarus, Belgium, Bulgaria, Canada, Chile, China, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, El Salvador, France, Georgia, Germany, Greece, Hong Kong, Hungary, Iceland, India, Indonesia, Israel, Italy, Jamaica, Japan, Korea, Kuwait, Latvia, Lebanon, Libya, Malaysia, Netherlands, New Zealand, Nicaragua, Norway, Pakistan, Poland, Portugal, Romania, Saudi Arabia, Singapore, Slovenia, Spain, Sweden, Switzerland, Taiwan, United Arab Emirates, United Kingdom, Venezuela, and Yemen.
  • 제품 설명
    Medtronic Disposable Pressure Display Set, Models 61000, 61006, 62000, 62006. Sterilized by Ethylene Oxide. Non-pyrogenic. Coiled PVC tubing with threaded transducer dome (acrylic) with silicone diaphragm on proximal end. Product utilizes a stopcock on proximal and/or distal end. Distal end of tubing features a male luer port. Manufacturer: Medtronic, Inc. 710 Medtronic Parkway, Minneapolis, MN 55432-5604. || Product Usage: This product is intended for use in monitoring catheter, cannula, or line pressures associated with cardiopulmonary bypass equipment and/or related products.
  • Manufacturer
    Medtronic Perfusion Systems