Devices

Device Recall LIFEPAK

  • 모델명 / 제조번호(시리얼번호)
    LP 20 domestic serial numbers 34107307, 33911492, 33946302, 33894355, 33933894, 33951494, 33980272, 33986554, 33924702, 33881437, 33905482, 33894423, 33951266, 33905466, 33955767, 33971830, 34022189, 34071195, 34107256, 33900980, 33971829, 33980275, 33980280, 33980281, 33980287, 34017814, 34107419, 34071134, 33986933, 33947927, 34071165, 33967385, 34066585, 34071189, 34011819, 34011822, 33894426, 33894572, 33900981, 33936889, 34054495, 34060183, 33938363, 33959538, 33981789, 33981792, 33981793, 33981794, 33981795, 33981796, 33981797, 33981799, 33981805, 34071237, 34011821, 33894425, 33922299, 33938921, 33938924, 33959550, 33930122, 33933904, 34107178, 33955760, 33897337, 33955747, 33894255, 33951295, 33951456, 33976455, 33951447, 33894406, 33951275, 33933878, 33946268, 33946277, 33976406, 33976407, 33976408, 33976410, 33976411, 33976412, 33976413, 33976414, 33976415, 33976416, 33976417, 33976418, 33976419, 33976420, 33976424, 33976426, 33976427, 33976428, 33976429, 33976430, 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33967369, 33967380, 33967386, 33967389, 33971922, 33971927, 33971942, 33971944, 33976461, 34071168, 33951124, 33959569, 33986833, 34071131, 34071140, 34071218, 33951548, 33065288, 33070529, 33901097, 33901101, 33901118, 33955845, 33894412, 33911590, 34022173, 33894578, 33894590, 33898503, 33901090, 33938929, 33894567, 33894586, 33986904, 33894589, 33980277, 33951584, 34107402, 33936859, 33936861, 33936886, 33936892, 33936907, 33981779, 33986837, 34054501, 34054502, 34107156, 33947934, 33947940, 33955799, 30559207, 31275938, 30587151, 33814952, 33955835, 33936909, 33936912, 33946300, 33946321, 33947896, 33947921, 33922371, 33971945, 33986544, 34066487, 34066510, 34107280, 33976445, 33976448, 33976450, 33976452, 33976457, 33976459, 33976460, 33976465, 33922296, 33955773, 33955817, 33955836, 33955837, 33955844, 33955851, 33959542, 30553849, 30553852, 31305464, 34015706, 33894401, 33947912, 33933900, 33980289, 33933881, 33976422, 33979498, 33979520, 33979556, 33946310, 34071198, 34071203, 34107240, 34107415, 34107420 Military serial numbers: 33894425, 33894255, 33997567, 33959578, 33894287, 33938356, 33938357, 33938359, 33938928, 33951441, 33951459, 33955756, 33955770, 33955778, 33955779, 33955780, 33955781, 33955782, 33955784, 33955785, 33955787, 33955788, 33955789, 33955790, 33955791, 33955793, 33955795, 33955796, 33955798, 33955800, 33955801, 33955805, 33955830, 33955846, 33955847, 33955853, 33959560, 33959561, 33959562, 33959568, 33959572, 33959573, 33959574, 33959602, 33959603, 33959609, 33981808, 33981809, 33986865, 33992540, 33992542, 33992545, 33992547, 33992549, 33992550, 33992552, 33992553, 33992554, 33992555, 33992556, 33992557, 33992558, 33992559, 33992560, 33992561, 33992562, 33992563, 33992564, 33992565, 33992566, 33992567, 33992568, 33992571, 33992572, 34022190, 34022191, 34022193, 34022194, 34022196, 34022197, 34022199, 34022200, 34052635, 34052637, 34052638, 34052641, 34052642, 34052643, 34052645, 34052646, 34052647, 34052652, 34052656, 34052657, 34052665, 34052671, 34052672, 34052675, 34052676, 34052677, 34052679, 34052683, 34052684, 34052692, 34052695, 34054492, 34054494, 34054500, 34054510, 34054512, 34054532, 34054534, 34060185, 34060186, 34060187, 34060188, 34060189, 34060190, 34060193, 34060194, 34060195, 34060196, 34060200, 34060201, 34060205, 34060209, 34060210, 34060214, 34060215, 34060216, 34060819, 34060820, 34060824   International serial numbers: 33947246, 33947247, 33892605, 33893092, 33894357, 33894359, 33894360, 33894366, 33894369, 33894370, 33894373, 33894378, 33894380, 33933865, 33933874, 33933882, 33933948, 33946270, 33946278, 34003572, 34003579, 34003584, 34003597, 33894325, 33900857, 33930119, 33933884, 33933887, 33933889, 33933892, 33933893, 33933895, 33933898, 33933912, 33933913, 33971956, 34071200, 34107253, 34107377, 34107381, 33894298, 33894427, 33950568, 33950569, 33959558, 33959599, 34052644, 34052668, 34052670, 34060818, 34060845, 34060846, 34060848, 34063584, 34063586, 34063591, 34063629, 34063634, 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33922354, 33971943, 33971947, 33971955, 33976434, 33976436, 33976437, 33976440, 33976443, 33981765, 33986907, 34017812, 34071188, 33981806, 33986830, 33894245, 33894246, 33894247, 33894248, 33894249, 33894254, 33894256, 33894292, 33894293, 33894295, 33894296, 33894297, 33894299, 33894300, 33894301, 33894302, 33894303, 33894304, 33894305, 33894312, 33894313, 33894314, 33894393, 33894395, 33894396, 33894397, 33894398, 33894399, 33894400, 33894402, 33894403, 33894405, 33894407, 33894408, 33894575, 33894576, 33894595, 33950445, 33951111, 33959537, 33981804, 33981807, 33981810, 33981811, 33986816, 33986817, 33986818, 33986819, 33986820, 33986821, 33986822, 33986824, 33986828, 33986831, 33986834, 34063626, 34063641, 34066564, 33893102, 34011831, 34017800, 34071132, 33894391, 34107239, 34107270, 34107330, 34107339, 34107391, 34107392, 34107398, 34107399, 33986928, 33990259, 33881434, 33881439, 33881441, 33892607, 33892617, 33893073, 33893081, 33893094, 33894550, 33898433, 33898443, 33898444, 33932691, 33932735, 33933862, 33933880, 33933933, 33933934, 33933935, 33933936, 33933940, 33933943, 33946284, 33946290, 33946291, 33946292, 33947871, 33947873, 33881436, 33893100, 33893103, 33947878, 33947887, 34003621, 33892589, 33892591, 33892592, 33892596, 33892597, 33892598, 33892600, 33892604, 33892608, 33892610, 33892615, 33892619, 33892621, 33893077, 33893080, 33893084, 33893087, 33893089, 33893091, 33893095, 33892606, 33892609, 33893088, 33894372, 34003564, 34003588, 34003590, 34003605, 34003611, 34003619, 34003628, 34011697, 34011704, 34011707, 33881438, 33929478, 33932732, 33933871, 33947881, 33947889, 33979529, 33979559, 34003594, 33905606, 33905624, 33911517, 33922360, 33922361, 33922366, 33930126, 33936882, 33936890, 33936901, 33936905, 33936908, 33946309, 34066514, 33911514, 33911519, 33930111, 33947932, 33971915, 33971930, 33971952, 33971960, 33976435, 33976467, 33980269, 33980292, 33990251, 33990255, 33990257, 33990260, 33990261, 33990264, 33990269, 34017740, 34017797, 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33976466, 33976469, 33980302, 33981785, 33986347, 33986875, 33986914, 33986918, 33990263, 34015701, 34015716, 34015732, 34015743, 34017772, 34017802, 34017811, 34022165, 34022170, 34066480, 34066482, 34066484, 34066485, 34066486, 34066488, 34066489, 34066490, 34066494, 34066495, 34066497, 34066499, 34066500, 34066501, 34066503, 34071162, 34071167, 34071177, 33894422, 33897347, 33950575, 33950579, 33951103, 33951401, 33894250, 33894570, 33897330, 33897334, 33897345, 33897349, 33897351, 33905504, 33951122, 33951127, 33951587, 33951591, 33955843, 33959557, 33959604, 33981801, 34052678,34052680, 34054490, 34063618, 33897348, 33955850, 33959543, 33959551, 33992548, 34063613, 33894251, 33894294, 33897338, 33897339, 33951271, 33951402, 34107069, 33922297, 33950447, 33950452, 33950453, 33950454, 33950455, 33950456, 33950457, 33950570, 33950572, 33950573, 33950576, 33950578, 33955783, 33959541, 33959548, 34107110, 33884883, 33955777, 33986326, 33893098, 33893104, 33893105, 33893106, 33894356, 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34011834, 33894324, 33915927, 33922362, 33922370, 33947911, 33947914, 33997578, 34011813, 34015723, 34066506, 34066509, 34066511, 33915933, 33922363, 33922367, 33922368, 33922375, 33924666, 34107387, 33915943, 33924700, 33930108, 33930115, 33930120, 33930123, 33933883, 33933885, 33933891, 33933902, 30523635, 33890401, 33892594, 33892599, 33892601, 33892603, 33933860, 33933873, 33933946, 33933947, 33933955, 33933956, 33946267, 33946273, 33946276, 33946280, 33946283, 33947880, 33947891, 33979545, 33986794, 33991477, 33991478, 33991483, 33991494, 33991499, 34003565, 34003589, 34011705, 34011708, 34022206, 34022210, 34022211, 34022212, 33894317, 33924662, 33924671, 33924673, 33924674, 33924676, 33924680, 33930099, 33930100, 33980270, 33980299, 33980305, 33986926, 33986927, 33986930, 33986932, 33990256, 33990258, 33990266, 33997553, 33997574, 33997575, 34011829, 34066496, 34066508, 34066513, 34066519, 34071146, 34071149, 34071150, 34071151, 34071157, 34003578, 33922376, 33922378, 33922382, 33924665, 33924669, 33924672, 33924678, 33924683, 33924691, 33930141, 33933903, 33814107, 33892588, 33892590, 33892595, 33892611, 33892620, 33893072, 33893075, 33933897, 33947895, 33947906, 33947918, 33947926, 33947928, 33922295, 33951064, 33894253, 33959545, 33938358, 33950582, 33950585, 33951084, 33951117, 33951119, 33951120, 33951123, 33951125, 33951126, 33951132, 34052681, 33938361, 33955823, 33959544, 33959553, 33959566, 33959607, 33959608, 33981790, 34054517, 33938925, 33950586, 33951074, 33951115, 33951116, 34022198, 33959600, 34054528, 34054531, 33894387, 34003571, 34003574, 34003576, 34003596, 34003599, 34011715, 34011717, 34011722, 33905620, 34015714, 34017733, 34017798, 34017805, 34071191, 34060841, 34066568, 33915902, 33820870, 33829090, 33829105, 33884866, 33884867, 33884871, 33884872, 33884879, 33884912, 33884898, 33819680, 33829407, 33826068, 33884924, 33951423, 33790153, 33814964, 33884875, 33884882, 33884911, 33884958, 33613420, 33818739, 33826069, 33826084, 33884945, 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33889486, 33889487, 33889488, 33889489, 33889490, 33889491, 33889492, 33889493, 33889494, 33889496, 33889500, 33890399, 33890412, 33890413, 33890414, 33890415, 33890416, 33890418, 33427202, 33488173, 33805092, 33808075, 33818756, 33818757, 33818766, 33818781, 33818782, 33818785, 33819638, 33819645, 33819648, 33819674, 33826083, 33826093, 33826094, 33884931, 33884942, 33884946, 33884948, 33889428, 33884917, 33820892, 33884881, 33884892, 33804989, 33884874, 33884878, 33884870, 33884896, 33814974, 33829114, 33829120, 33884887, 33884890, 33884897, 33884899, 33814227, 33814155, 33881368, 33881385, 33881388, 33881397, 33881419, 33889483, 33889498, 33889499, 33889501, 33889502, 33890400, 33890410, 33890420, 33890421, 33890422, 33890423, 33890424, 33884888, 33884901, 33884902, 33884903, 33884904, 33884908, 33884910, 33826076, 33884928
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Units were distributed worldwide to hospitals and medical centers.
  • 제품 설명
    LIFEPAK 20 external defibrillator/monitor
  • Manufacturer
    Medtronic Emergency Response Systems, Inc.
  • 1 Event

제조사

Medtronic Emergency Response Systems, Inc.
  • 제조사 주소
    Medtronic Emergency Response Systems, Inc., 11811 Willows Rd Ne, Redmond WA 98052-2003
  • Source
    USFDA

유사한 이름을 가진 의료기기 1건 유사한 이름을 가진 의료기기 33 건

데이터에 대해 더 자세히 알아보기 여기

Device Recall LIFEPAK15 monitor/defibrillator
  • 모델명 / 제조번호(시리얼번호)
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    3
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US (nationwide) including Guam and Puerto Rico and Internationally to ¿land Islands, Algeria, Argentina, Aruba, Australia, Austria, Azerbaijan, Bahrain, Barbados, Belgium, Bosnia and Herzegovina, Botswana, Brazil, Brunei Darussalam, Cambodia, Canada, Cayman Islands, Chile, China, Costa Rica, Croatia, Cura¿ao, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Eritrea, Faroe Islands, Finland, France, French Guiana, French Polynesia, Georgia, Germany, Greece, Guadeloupe, Guinea, Guyana, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Islamic Republic of, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Republic of, Kosovo, Kuwait, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Macedonia, the former Yugoslav Republic of, Malaysia, Maldives, Malta, Martinique, Mauritius, Mayotte, Mexico, Morocco, Mozambique, Namibia, Netherlands, New Caledonia, New Zealand, Norway, Oman, Pakistan, Panama, Papua New Guinea, Poland, Portugal, Qatar, R¿union, Romania, Russian Federation, San Marino, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Suriname, Sweden, Switzerland, Taiwan, Province of China, Thailand, Trinidad and Tobago, Turkey, Ukraine, United Arab Emirates, United Kingdom, and Yemen.
  • 제품 설명
    LIFEPAK15 monitor/defibrillator with End-Tidal C02 (EtC02) feature installed. || Part numbers: || V15-2-xxxxxx (includes software version 1 and version 2); || V15-5-xxxxxx (inclues software version 4). || The LIFEPAK 15 monitor/defibrillator is intended for use by trained medical personnel in outdoor and indoor emergency care settings within the environmental conditions specified. The LIFEPAK 15 monitor/defibrillator is designed to be used during ground transportation except when specified otherwise. Manual mode monitoring and therapy functions are intended for use on adult and pediatric patients. Automated external defibrillation mode is intended for use on patients eight years of age and older.
  • Manufacturer
    Physio-Control, Inc.
Device Recall LIFEPAK CR Plus and/or LIFEPAK EXPRESS
  • 모델명 / 제조번호(시리얼번호)
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    3
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution-US (nationwide) including Guam and Puerto Rico and countries of: Argentina, Austria, Australia, Bahamas, Bangladesh, Belgium, Brazil, Brunei Darussalami, Canada, Chile, China, Croatia, Cyprus. Czech Republic, Denmark, Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, India, Indonesia, Ireland, Israel, Italy, Japan, Kazakhstan, Kenya, Lithuania, Luxembourg, Malta, Mexico, Netherlands, Norway, Philippines, Poland, Portugal, Qatar, Russian Federation, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan (Province of China), Turkey, United Arab Emirates, United Kingdom, New Caledonia, and New Zealand,.
  • 제품 설명
    LIFEPAK CR Plus and/or LIFEPAK EXPRESS are Automatic External Defibrillator(s) and are non-wearable. || LIFEPAK CR Plus and LIFEPAK EXPRESS defibrillators are intended for use on patients in cardiac arrest.
  • Manufacturer
    Physio-Control, Inc.
Device Recall LIFEPAK 15 Monitor/Defibrillator
  • 모델명 / 제조번호(시리얼번호)
    SERIAL NUMBERS:  42738872, 44554102, 42701550, 42702539, 42730815, 42800549, 42803986, 42862109, 42884428, 42944609, 42989327, 43022460, 43040692, 43048791, 43066974, 43116838, 43116994, 43119477, 43132954, 43133203, 43133221, 43133906, 43154308, 43154457, 43156695, 43161425, 43163930, 43164076, 43164158, 43166133, 43206034, 43210019, 43219622, 43226291, 43230032, 43232487, 43232904, 43247389, 43251050, 43253506, 43253916, 43254032, 43258901, 43293290, 43321556, 43388132, 43388137, 43388541, 43405542, 43407947, 43409346, 43429508, 43465372, 43472036, 43472591, 43480824, 43489606, 43492883, 43576021, 43616526, 43641893, 43691775, 43715563, 43735849, 43764249, 43800357, 43805213, 43825370, 43826635, 43843347, 43869096, 43884778, 43922984, 43938506, 43947198, 43962139, 43964195, 43968233, 43981293, 43999541, 44010117, 44010465, 44039473, 44056838, 44060132, 44072885, 44073149, 44090669, 44092118, 44094122, 44108545, 44112183, 44117966, 44150897, 44167052, 44168042, 44179750, 44199424, 44225054, 44225258, 44226227, 44226585, 44226654, 44231094, 44233618, 44234803, 44234840, 44237875, 44255648, 44262283, 44262826, 44264102, 44264573, 44265421, 44271391, 44283558, 44287000, 44289115, 44293297, 44303302, 44312782, 44315479, 44327764, 44342010, 44352664, 44372343, 44416667, 44435825, 44438567, 44439898, 44449825, 44450073, 44452220, 44458445, 44460124, 44460749, 44463853, 44466514, 44473363, 44483809, 44486872, 44487784, 44487992, 44488101, 44489681, 44492189, 44492223, 44492252, 44492760, 44492832, 44494129, 44496734, 44497169, 44497196, 44497761, 44497866, 44498576, 44500827, 44500943, 44501037, 44501047, 44501112, 44501201, 44501465, 44501806, 44501832, 44502009, 44502159, 44502179, 44502310, 44502686, 44502718, 44502776, 44502815, 44502943, 44503096, 44508212, 44508273, 44508330, 44508331, 44508358, 44508440, 44508498, 44508645, 44508868, 44509074, 44509520, 44509538, 44511211, 44511231, 44511273, 44511519, 44511573, 44512604, 44513321, 44513358, 44518244, 44518479, 44518497, 44518703, 44518786, 44518917, 44518981, 44519083, 44519095, 44519255, 44519301, 44519307, 44519381, 44519548, 44524967, 44525130, 44525416, 44527324, 44530479, 44530594, 44530719, 44530800, 44531488, 44531803, 44532088, 44534804, 44534900, 44534991, 44535111, 44535241, 44535452, 44535582, 44535643, 44536176, 44536780, 44536823, 44536897, 44538798, 44538819, 44539781, 44539880, 44541779, 44541917, 44548263, 44548530, 44548558, 44548749, 44548825, 44549064, 44549220, 44549413, 44549964, 44550150, 44550234, 44550467, 44550552, 44550575, 44550613, 44550642, 44550675, 44552029, 44552066, 44552865, 44553122, 44554175, 44554259, 44554351, 44554520, 44554837, 44554941, 44555058, 44555261, 44556688, 44557824, 44558175, 44558252, 44558385, 44559077, 44559369, 44559455, 44560001, 44560185, 44561655, 44561903, 44562074, 44562559, 44562662, 44562754, 44563762, 44564474, 44564491, 44571952, 44572025, 44572171, 44572228, 44572357, 44572374, 44572595, 44572865, 44573101, 44573148, 44573485, 44573956, 44574467, 44574766, 44574771, 44574821, 44574929, 44574939, 44575793, 44575871, 44575898, 44576359, 44576647, 44577004, 44577022, 44577116, 44577219, 44578054, 44578080, 44578192, 44578272, 44579036, 44579299, 44579496, 44579697, 44579713, 44579857, 44581304, 44581382, 44583260, 44583657, 44583701, 44584213, 44586462, 44587097, 44587099, 44587181, 44587302, 44587358, 44587899, and 44587976.
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    3
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution-US ( nationwide) in states of: AZ, CA, CO, CT, FL, GA, IA, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SD, TX, VA, WA, WI, and WV and countries of: Australia, Brazil, Canada, Czech Republic, Denmark, Finland, France, French Guiana, Germany, India, Ireland, Israel, Italy, Japan, Latvia, Lithuania, Luxembourg, Malaysia, Netherlands, New Zealand, Norway, Poland, Qatar, Saudi Arabia, Slovenia, South Africa, Sweden, Turkey, United Arab Emirates, and United Kingdom.
  • 제품 설명
    LIFEPAK 15 Monitor, Automated External Defibrillator (AED), Manual mode monitoring and therapy functions are intended for use on adult and pediatric patients. Automated external defibrillation mode is intended for use on patients eight years of age and older.
  • Manufacturer
    Physio-Control, Inc.
Device Recall LIFEPAK 12 Defibrillator/Monitor
  • 모델명 / 제조번호(시리얼번호)
    LOT NUMBERS OF AFFECTED MODULE: Lot # 1520 and 1544.  SERIAL NUMBERS OF DEVICES:  32877820, 34356891, 35984435, 37223110, 37440401, 37456675, and 37913307.
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    3
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution. LifePak 12 distributed in US states of AL, GA, NY, SC, and in Australia. LifePak 15 distributed nationwide in the US including Puerto Rico and to ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, BAHRAIN, BELGIUM, CANADA, CHILE, CZECH REPUBLIC, DENMARK, FINLAND, FRANCE, FRENCH GUIANA, GERMANY, GREECE, HUNGARY, ICELAND, IRELAND, ITALY, LITHUANIA, LUXEMBOURG, NETHERLANDS, NEW ZEALAND, NORWAY, POLAND, PORTUGAL, SAUDI ARABIA, SENEGAL, SERBIA, SLOVENIA, SOUTH AFRICA, SPAIN, SWITZERLAND, TAHITI, UNITED ARAB EMIRATES, AND UNITED KINGDOM.
  • 제품 설명
    LIFEPAK 12 Defibrillator/Monitor with End-Tidal CO2 option. || The device is used in various areas of the hospital such as critical areas (emergency departments, critical care, operating room, etc.) and general duty floors (e.g. medical/surgical). || The device is also used for in and out of hospital transport (air and ground ambulance, in hospital transport, etc.)
  • Manufacturer
    Physio-Control, Inc.
Device Recall LIFEPAK 1000 defibrillator
  • 모델명 / 제조번호(시리얼번호)
    Affected Product Part Numbers: 320371500XX. There are 133,330 affected serial numbers.
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    3
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US (nationwide) and in the following countries: Bahrain, Belize, Cambodia, Chile, China, C¿te d'Ivoire, Ecuador, Germany, Honduras, Hong Kong, India, Indonesia, Jamaica, Myanmar, Netherlands, Niger, Philippines, Saudi Arabia, Senegal, Singapore, Sri Lanka, Thailand, Tunisia, Ukraine, and Zambia.
  • 제품 설명
    The LIFEPAK 1000 defibrillator is intended for use by personnel who are authorized by a physician/medical director and are trained in CPR and the use of the LIFEPAK 1000 defibrillator.
  • Manufacturer
    Physio-Control, Inc.
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