Rappel de Device Recall Ikaria INOMAX DS Drug Delivery System

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Ikaria Holdings.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    56290
  • Classe de risque de l'événement
    Class 1
  • Numéro de l'événement
    Z-2176-2010
  • Date de mise en oeuvre de l'événement
    2010-07-21
  • Date de publication de l'événement
    2010-08-13
  • Statut de l'événement
    Terminated
  • Pays de l'événement
  • Date de fin de l'événement
    2011-12-27
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
  • Notes / Alertes
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notes supplémentaires dans les données
    Apparatus, nitric oxide delivery - Product Code MRN
  • Cause
    The pressure switch in the inomax ds drug-delivery system may fail, which may interrupt or delay the administration of inomax (nitric oxide) for inhalation to patients. delay in administration of inomax therapy may cause: -worsening of systemic oxygenation indices (i.E., hypoxemia, especially manifested as decreased arterial oxygenation saturation). -hypotension, and/or -increase in pulm.
  • Action
    Ikaria sent an Urgent Medical Device Recall letter to customers dated July 21, 2010. This letter is also posted on the Inomax webpage. The letter described the issue, how to recognize it, what to do in the event of a suspected leak, and recommended maintaining back-up cylinders and depressurization of the regulator when not in use. The replacement plan for all INOMAX DS drug-delivery systems was described. Customers can contact Ikaria Customer Care at 1-877-566-9466.

Device

  • Modèle / numéro de série
    serial numbers: DS20070005, DS20070008, DS20070009, DS20070010, DS20070011, DS20070012, DS20070014, DS20070015, DS20070016, DS20070017, DS20070019, DS20070020, DS20070021, DS20070022, DS20070023, DS20070024, DS20070028, DS20070030, DS20070031, DS20070032, DS20070033, DS20070034, DS20070035, DS20070037, DS20070041, DS20070045, DS20070046, DS20070048, DS20070049, DS20070050, DS20070051, DS20070053, DS20070057, DS20070058, DS20070059, DS20070061, DS20070062, DS20070063, DS20070064, DS20070068, DS20070069, DS20070070, DS20070072, DS20070073, DS20070075, DS20070076, DS20070077, DS20070078, DS20070079, DS20070080, DS20070081, DS20070082, DS20070083, DS20070084, DS20070085, DS20070086, DS20070087, DS20070092, DS20070093, DS20070095, DS20070096, DS20070097, DS20070100, DS20070103, DS20070104, DS20070106, DS20070107, DS20070109, DS20070114, DS20070115, DS20070116, DS20070117, DS20070118, DS20070119, DS20070121, DS20070122, DS20070123, DS20070125, DS20070127, DS20070128, DS20070129, DS20070130, DS20070132, DS20070134, DS20070135, DS20070138, DS20070139, DS20070140, DS20070141, DS20070142, DS20070145, DS20070146, DS20070147, DS20070148, DS20070149, DS20070150, DS20070153, DS20070154, DS20070156, DS20070157, DS20070158, DS20070160, DS20070161, DS20070163, DS20070164, DS20070166, DS20070167, DS20070168, DS20070170, DS20070171, DS20070172, DS20070173, DS20070174, DS20070179, DS20070181, DS20070182, DS20070183, DS20070184, DS20070185, DS20070186, DS20070187, DS20070188, DS20070191, DS20070192, DS20070194, DS20070195, DS20070196, DS20070197, DS20070198, DS20070201, DS20070202, DS20070203, DS20070204, DS20070207, DS20070208, DS20070210, DS20070212, DS20070213, DS20070215, DS20070216, DS20070217, DS20070219, DS20070220, DS20070221, DS20070223, DS20070224, DS20070225, DS20070226, DS20070227, DS20070229, DS20070230, DS20070231, DS20070232, DS20070233, DS20070236, DS20070237, DS20070239, DS20070240, DS20070243, DS20070244, DS20070245, DS20070247, DS20070249, DS20070251, DS20070252, DS20070253, DS20070254, DS20070255, DS20070256, DS20070257, DS20070258, DS20070259, DS20070260, DS20070261, DS20070262, DS20070265, DS20070267, DS20070268, DS20070272, DS20070274, DS20070275, DS20070276, DS20070278, DS20070279, DS20070280, DS20070281, DS20070283, DS20080001, DS20080004, DS20080005, DS20080006, DS20080009, DS20080011, DS20080016, DS20080019, DS20080020, DS20080021, DS20080022, DS20080023, DS20080025, DS20080026, DS20080027, DS20080028, DS20080029, DS20080030, DS20080033, DS20080034, DS20080035, DS20080036, DS20080038, DS20080040, DS20080041, DS20080043, DS20080045, DS20080046, DS20080047, DS20080048, DS20080049, DS20080050, DS20080051, DS20080052, DS20080053, DS20080054, DS20080055, DS20080056, DS20080057, DS20080058, DS20080061, DS20080063, DS20080064, DS20080067, DS20080068, DS20080069, DS20080072, DS20080073, DS20080074, DS20080076, DS20080077, DS20080079, DS20080080, DS20080081, DS20080082, DS20080084, DS20080086, DS20080087, DS20080088, DS20080089, DS20080090, DS20080092, DS20080095, DS20080097, DS20080098, DS20080099, DS20080100, DS20080102, DS20080103, DS20080104, DS20080105, DS20080106, DS20080107, DS20080109, DS20080111, DS20080112, DS20080113, DS20080114, DS20080115, DS20080116, DS20080117, DS20080118, DS20080119, DS20080120, DS20080121, DS20080122, DS20080123, DS20080124, DS20080125, DS20080127, DS20080128, DS20080129, DS20080130, DS20080132, DS20080133, DS20080134, DS20080135, DS20080136, DS20080137, DS20080138, DS20080141, DS20080142, DS20080143, DS20080144, DS20080145, DS20080146, DS20080147, DS20080148, DS20080149, DS20080150, DS20080152, DS20080153, DS20080155, DS20080158, DS20080159, DS20080160, DS20080161, DS20080163, DS20080164, DS20080165, DS20080166, DS20080167, DS20080168, DS20080170, DS20080171, DS20080172, DS20080174, DS20080176, DS20080180, DS20080181, DS20080182, DS20080183, DS20080184, DS20080185, DS20080186, DS20080187, DS20080188, DS20080189, DS20080191, DS20080192, DS20080194, DS20080195, DS20080196, DS20080198, DS20080201, DS20080202, DS20080203, DS20080204, DS20080205, DS20080206, DS20080207, DS20080209, DS20080210, DS20080211, DS20080212, DS20080214, DS20080215, DS20080216, DS20080217, DS20080218, DS20080219, DS20080220, DS20080221, DS20080222, DS20080223, DS20080224, DS20080225, DS20080227, DS20080228, DS20080229, DS20080230, DS20080231, DS20080232, DS20080233, DS20080234, DS20080236, DS20080237, DS20080239, DS20080241, DS20080242, DS20080243, DS20080244, DS20080245, DS20080246, DS20080249, DS20080250, DS20080252, DS20080253, DS20080254, DS20080255, DS20080256, DS20080258, DS20080259, DS20080260, DS20080261, DS20080262, DS20080263, DS20080264, DS20080265, DS20080266, DS20080268, DS20080269, DS20080270, DS20080271, DS20080273, DS20080275, DS20080276, DS20080278, DS20080279, DS20080280, DS20080281, DS20080282, DS20080283, DS20080284, DS20080285, DS20080286, DS20080287, DS20080289, DS20080291, DS20080292, DS20080298, DS20080299, DS20080300, DS20080303, DS20080304, DS20080306, DS20080307, DS20080308, DS20080309, DS20080310, DS20080312, DS20080313, DS20080318, DS20080320, DS20080321, DS20080322, DS20080323, DS20080325, DS20080326, DS20080327, DS20080328, DS20080330, DS20080331, DS20080333, DS20080334, DS20080335, DS20080336, DS20080337, DS20080338, DS20080341, DS20080342, DS20080343, DS20080346, DS20080348, DS20080349, DS20080356, DS20080357, DS20080358, DS20080361, DS20080362, DS20080363, DS20080364, DS20080365, DS20080368, DS20080370, DS20080373, DS20090001, DS20090002, DS20090003, DS20090004, DS20090005, DS20090006, DS20090007, DS20090008, DS20090009, DS20090011, DS20090013, DS20090014, DS20090015, DS20090016, DS20090017, DS20090020, DS20090021, DS20090024, DS20090026, DS20090027, DS20090029, DS20090031, DS20090032, DS20090033, DS20090034, DS20090035, DS20090037, DS20090039, DS20090042, DS20090043, DS20090045, DS20090046, DS20090048, DS20090051, DS20090052, DS20090054, DS20090057, DS20090058, DS20090059, DS20090063, DS20090064, DS20090065, DS20090066, DS20090068, DS20090069, DS20090071, DS20090072, DS20090073, DS20090074, DS20090076, DS20090077, DS20090080, DS20090082, DS20090084, DS20090085, DS20090086, DS20090088, DS20090089, DS20090090, DS20090091, DS20090092, DS20090093, DS20090094, DS20090095, DS20090096, DS20090097, DS20090098, DS20090099, DS20090100, DS20090101, DS20090102, DS20090103, DS20090104, DS20090105, DS20090106, DS20090107, DS20090108, DS20090110, DS20090112, DS20090113, DS20090114, DS20090116, DS20090118, DS20090119, DS20090121, DS20090122, DS20090123, DS20090124, DS20090125, DS20090127, DS20090128, DS20090129, DS20090130, DS20090132, DS20090133, DS20090134, DS20090135, DS20090136, DS20090137, DS20090138, DS20090139, DS20090141, DS20090142, DS20090144, DS20090145, DS20090146, DS20090147, DS20090149, DS20090150, DS20090151, DS20090152, DS20090153, DS20090156, DS20090157, DS20090158, DS20090159, DS20090160, DS20090161, DS20090162, DS20090164, DS20090165, DS20090166, DS20090168, DS20090169, DS20090170, DS20090171, DS20090172, DS20090173, DS20090174, DS20090175, DS20090176, DS20090177, DS20090178, DS20090179, DS20090180, DS20090181, DS20090182, DS20090183, DS20090185, DS20090189, DS20090190, DS20090191, DS20090192, DS20090193, DS20090196, DS20090197, DS20090198, DS20090200, DS20090201, DS20090202, DS20090203, DS20090204, DS20090205, DS20090206, DS20090207, DS20090208, DS20090209, DS20090210, DS20090211, DS20090212, DS20090213, DS20090214, DS20090215, DS20090216, DS20090218, DS20090219, DS20090220, DS20090221, DS20090222, DS20090223, DS20090224, DS20090225, DS20090226, DS20090227, DS20090230, DS20090231, DS20090232, DS20090233, DS20090235, DS20090236, DS20090238, DS20090239, DS20090240, DS20090242, DS20090243, DS20090244, DS20090245, DS20090247, DS20090248, DS20090249, DS20090250, DS20090251, DS20090252, DS20090253, DS20090256, DS20090257, DS20090259, DS20090260, DS20090261, DS20090262, DS20090263, DS20090265, DS20090266, DS20090267, DS20090268, DS20090269, DS20090270, DS20090271, DS20090273, DS20090274, DS20090275, DS20090277, DS20090278, DS20090279, DS20090280, DS20090281, DS20090282, DS20090283, DS20090284, DS20090288, DS20090289, DS20090290, DS20090291, DS20090292, DS20090293, DS20090294, DS20090295, DS20090297, DS20090299, DS20090300, DS20090301, DS20090302, DS20090303, DS20090304, DS20090305, DS20090306, DS20090307, DS20090308, DS20090309, DS20090311, DS20090313, DS20090314, DS20090315, DS20090316, DS20090318, DS20090319, DS20090320, DS20090321, DS20090322, DS20090323, DS20090324, DS20090326, DS20090327, DS20090332, DS20090333, DS20090334, DS20090335, DS20090336, DS20090338, DS20090341, DS20090343, DS20090344, DS20090345, DS20090346, DS20090347, DS20090348, DS20090349, DS20090351, DS20090353, DS20090354, DS20090356, DS20090357, DS20090358, DS20090359, DS20090360, DS20090361, DS20090362, DS20090365, DS20090367, DS20090369, DS20090371, DS20090372, DS20090373, DS20090375, DS20090380, DS20090381, DS20090383, DS20090386, DS20090387, DS20090388, DS20090390, DS20090392, DS20090393, DS20090394, DS20090396, DS20090397, DS20090401, DS20090402, DS20090404, DS20090405, DS20090407, DS20090408, DS20090409, DS20090410, DS20090411, DS20090414, DS20090417, DS20090418, DS20090420, DS20090422, DS20090428, DS20090430, DS20090431, DS20090432, DS20090434, DS20090435, DS20090436, DS20090437, DS20090438, DS20090439, DS20090444, DS20090445, DS20090448, DS20090453, DS20090455, DS20090459, DS20090461, DS20090462, DS20090465, DS20090466, DS20090468, DS20090469, DS20090470, DS20090472, DS20090474, DS20090479, DS20090480, DS20090483, DS20090484, DS20090487, DS20090488, DS20090492, DS20090493, DS20090495, DS20090496, DS20090498, DS20090499, DS20090500, DS20090501, DS20090502, DS20090504, DS20090505, DS20090506, DS20090507, DS20090508, DS20090509, DS20090511, DS20090512, DS20090513, DS20090516, DS20090517, DS20090518, DS20090520, DS20090523, DS20090524, DS20090525, DS20090526, DS20090527, DS20090531, DS20090532, DS20090533, DS20090534, DS20090536, DS20090538, DS20090539, DS20090540, DS20090541, DS20090542, DS20090543, DS20090544, DS20090545, DS20090546, DS20090549, DS20090550, DS20090553, DS20090554, DS20090555, DS20090556, DS20090557, DS20090558, DS20090560, DS20090561, DS20090562, DS20090563, DS20090564, DS20090565, DS20090566, DS20090567, DS20090569, DS20090570, DS20090571, DS20090573, DS20090574, DS20090575, DS20090576, DS20090578, DS20090580, DS20090582, DS20090583, DS20090584, DS20090585, DS20090586, DS20090587, DS20090588, DS20090589, DS20090590, DS20090591, DS20090592, DS20090593, DS20090594, DS20090595, DS20090596, DS20090597, DS20090598, DS20090600, DS20090601, DS20090602, DS20090603, DS20090604, DS20090605, DS20090606, DS20090607, DS20090608, DS20090609, DS20090610, DS20090611, DS20090612, DS20090614, DS20090615, DS20090616, DS20090617, DS20090618, DS20090619, DS20090620, DS20090622, DS20090623, DS20090624, DS20090625, DS20090626, DS20090627, DS20090629, DS20090630, DS20090631, DS20090632, DS20090633, DS20090634, DS20090635, DS20090636, DS20090637, DS20090639, DS20090640, DS20090641, DS20090642, DS20090643, DS20090644, DS20090645, DS20090646, DS20090647, DS20090648, DS20090649, DS20090650, DS20090651, DS20090653, DS20090654, DS20090655, DS20090656, DS20090658, DS20090659, DS20090660, DS20090661, DS20090662, DS20090664, DS20090665, DS20090666, DS20090667, DS20090668, DS20090669, DS20090670, DS20090671, DS20090672, DS20090673, DS20090674, DS20090675, DS20090676, DS20090678, DS20090679, DS20090680, DS20090681, DS20090682, DS20090683, DS20090684, DS20090685, DS20090686, DS20090687, DS20090689, DS20090690, DS20090691, DS20090692, DS20090693, DS20090694, DS20090695, DS20090696, DS20090697, DS20090698, DS20090699, DS20090700, DS20090701, DS20090702, DS20090703, DS20090704, DS20090705, DS20090706, DS20090707, DS20090708, DS20090709, DS20090710, DS20090711, DS20090712, DS20090713, DS20090714, DS20090715, DS20090716, DS20090717, DS20090718, DS20090719, DS20090720, DS20090721, DS20090722, DS20090723, DS20090724, DS20090725, DS20090726, DS20090727, DS20090729, DS20090730, DS20090731, DS20090732, DS20090733, DS20090734, DS20090735, DS20090736, DS20090737, DS20090739, DS20090740, DS20090741, DS20090742, DS20090744, DS20090745, DS20090746, DS20090747, DS20090748, DS20090749, DS20090750, DS20090751, DS20090752, DS20090753, DS20090754, DS20090755, DS20090756, DS20090757, DS20090758, DS20090759, DS20090760, DS20090761, DS20090762, DS20090763, DS20090764, DS20090765, DS20090766, DS20090767, DS20090768, DS20090769, DS20090770, DS20090771, DS20090772, DS20090773, DS20090774, DS20090775, DS20090776, DS20090777, DS20090778, DS20090779, DS20090780, DS20090781, DS20090783, DS20090784, DS20090785, DS20090786, DS20090787, DS20090788, DS20090789, DS20090790, DS20090792, DS20090795, DS20090796, DS20090798, DS20090799, DS20090800, DS20090801, DS20090802, DS20090804, DS20090805, DS20090807, DS20090808, DS20090809, DS20090810, DS20090811, DS20090812, DS20090814, DS20090816, DS20090817, DS20090818, DS20090819, DS20090820, DS20090821, DS20090824, DS20090825, DS20090827, DS20090828, DS20090829, DS20090832, DS20090833, DS20090834, DS20090835, DS20090836, DS20090837, DS20090838, DS20090839, DS20090840, DS20090843, DS20090844, DS20090845, DS20090846, DS20090847, DS20090848, DS20090849, DS20090850, DS20090851, DS20090852, DS20090854, DS20090855, DS20090857, DS20090858, DS20090859, DS20090860, DS20090861, DS20090862, DS20090863, DS20090864, DS20090865, DS20090866, DS20090867, DS20090868, DS20090869, DS20090870, DS20090871, DS20090872, DS20090873, DS20090874, DS20090875, DS20090876, DS20090877, DS20090878, DS20090879, DS20090880, DS20090881, DS20090882, DS20090883, DS20090885, DS20090886, DS20090887, DS20090888, DS20090890, DS20090891, DS20090892, DS20090893, DS20090894, DS20090896, DS20090897, DS20090898, DS20090899, DS20090900, DS20090901, DS20090902, DS20090903, DS20090904, DS20090905, DS20090906, DS20090907, DS20090908, DS20090909, DS20090910, DS20090911, DS20090912, DS20090913, DS20090914, DS20090915, DS20090916, DS20090917, DS20090918, DS20090919, DS20090920, DS20090921, DS20090922, DS20090924, DS20090925, DS20090926, DS20090927, DS20090928, DS20090929, DS20090931, DS20090932, DS20090933, DS20090934, DS20090935, DS20090936, DS20090937, DS20090938, DS20090939, DS20090940, DS20090941, DS20090942, DS20090943, DS20090944, DS20090945, DS20090946, DS20100001, DS20100002, DS20100003, DS20100004, DS20100005, DS20100006, DS20100007, DS20100008, DS20100009, DS20100010, DS20100011, DS20100013, DS20100014, DS20100015, DS20100016, DS20100017, DS20100019, DS20100020, DS20100021, DS20100022, DS20100023, DS20100024, DS20100025, DS20100026, DS20100027, DS20100028, DS20100029, DS20100030, DS20100031, DS20100032, DS20100033, DS20100034, DS20100035, DS20100036, DS20100037, DS20100038, DS20100039, DS20100040, DS20100041, DS20100042, DS20100043, DS20100044, DS20100046, DS20100048, DS20100049, DS20100050, DS20100051, DS20100055, DS20100056, DS20100057, DS20100058, DS20100059, DS20100060, DS20100061, DS20100062, DS20100063, DS20100065, DS20100066, DS20100068, DS20100069, DS20100070, DS20100072, DS20100073, DS20100074, DS20100075, DS20100076, DS20100077, DS20100078, DS20100079, DS20100080, DS20100081, DS20100082, DS20100083, DS20100084, DS20100085, DS20100086, DS20100087, DS20100089, DS20100090, DS20100091, DS20100092, DS20100094, DS20100095, DS20100097, DS20100098, DS20100099, DS20100100, DS20100102, DS20100104, DS20100105, DS20100106, DS20100107, DS20100108, DS20100109, DS20100112, DS20100114, DS20100115, DS20100116, DS20100117, DS20100118, DS20100119, DS20100120, DS20100122, DS20100123, DS20100125, DS20100126, DS20100127, DS20100128, DS20100129, DS20100130, DS20100131, DS20100132, DS20100134, DS20100135, DS20100136, DS20100137, DS20100138, DS20100140, DS20100141, DS20100142, DS20100143, DS20100144, DS20100146, DS20100147, DS20100148, DS20100150, DS20100151, DS20100153, DS20100154, DS20100155, DS20100156, DS20100158, DS20100159, DS20100160, DS20100161, DS20100162, DS20100163, DS20100164, DS20100165, DS20100166, DS20100167, DS20100168, DS20100169, DS20100170, DS20100171, DS20100172, DS20100174, DS20100176, DS20100177, DS20100178, DS20100180, DS20100181, DS20100182, DS20100183, DS20100184, DS20100185, DS20100186, DS20100187, DS20100188, DS20100191, DS20100193, DS20100194, DS20100195, DS20100196, DS20100197, DS20100198, DS20100199, DS20100200, DS20100201, DS20100204, DS20100206, DS20100207, DS20100208, DS20100209, DS20100210, DS20100211, DS20100212, DS20100213, DS20100214, DS20100216, DS20100217, DS20100218, DS20100221, DS20100223, DS20100224, DS20100225, DS20100226, DS20100227, DS20100228, DS20100229, DS20100230, DS20100231, DS20100232, DS20100233, DS20100234, DS20100235, DS20100236, DS20100237, DS20100238, DS20100239, DS20100240, DS20100241, DS20100242, DS20100243, DS20100244, DS20100245, DS20100246, DS20100248, DS20100249, DS20100250, DS20100251, DS20100252, DS20100253, DS20100254, DS20100255, DS20100256, DS20100257, DS20100258, DS20100259, DS20100260, DS20100262, DS20100263, DS20100264, DS20100265, DS20100266, DS20100267, DS20100268, DS20100269, DS20100270, DS20100271, DS20100272, DS20100273, DS20100274, DS20100275, DS20100276, DS20100278, DS20100279, DS20100280, DS20100281, DS20100282, DS20100283, DS20100284, DS20100285, DS20100286, DS20100287, DS20100288, DS20100289, DS20100290, DS20100291, DS20100292, DS20100293, DS20100294, DS20100295, DS20100297, DS20100298, DS20100299, DS20100300, DS20100301, DS20100302, DS20100303, DS20100304, DS20100305, DS20100306, DS20100307, DS20100308, DS20100309, DS20100311, DS20100312, DS20100314, DS20100316, DS20100317, DS20100318, DS20100319, DS20100322, DS20100323, DS20100324, DS20100326, DS20100327, DS20100328, DS20100329, DS20100331, DS20100332, DS20100333, DS20100335, DS20100336, DS20100337, DS20100339, DS20100340, DS20100341, DS20100342, DS20100343, DS20100344, DS20100345, DS20100346, DS20100347, DS20100349, DS20100350, DS20100351, DS20100352, DS20100355, DS20100358, DS20100359, DS20100360, DS20100362, DS20100363, DS20100365, DS20100366, DS20100368, DS20100370, DS20100372, DS20100374, DS20100375, DS20100376, DS20100377, DS20100378, DS20100379, DS20100380, DS20100381, DS20100382, DS20100383, DS20100384, DS20100385, DS20100386, DS20100387, DS20100389, DS20100390, DS20100391, DS20100392, DS20100393, DS20100394, DS20100396, DS20100397, DS20100398, DS20100399, DS20100400, DS20100401, DS20100405, DS20100406, DS20100407, DS20100408, DS20100409, DS20100411, DS20100412, DS20100413, DS20100414, DS20100415, DS20100416, DS20100417, DS20100418, DS20100419, DS20100420, DS20100421, DS20100424, DS20100425, DS20100427, DS20100429, DS20100430, DS20100432, DS20100433, DS20100434, DS20100435, DS20100436, DS20100437, DS20100438, DS20100439, DS20100440, DS20100441, DS20100442, DS20100443, DS20100444, DS20100445, DS20100446, DS20100448, DS20100449, DS20100451, DS20100452, DS20100453, DS20100455, DS20100456, DS20100457, DS20100458, DS20100459, DS20100460, DS20100461, DS20100462, DS20100463, DS20100464, DS20100465, DS20100466, DS20100467, DS20100468, DS20100470, DS20100471, DS20100472, DS20100475, DS20100476, DS20100478, DS20100479, DS20100480, DS20100481, DS20100482, DS20100483, DS20100485, DS20100486, DS20100487, DS20100488, DS20100490, DS20100491, DS20100492, DS20100494, DS20100496, DS20100497, DS20100498, DS20100499, DS20100500, DS20100501, DS20100502, DS20100503, DS20100504, DS20100505, DS20100506, DS20100507, DS20100511, DS20100515, DS20100516, DS20100517, DS20100518, DS20100519, DS20100520, DS20100521, DS20100523, DS20100524, DS20100525, DS20100526, DS20100527, DS20100528, DS20100529, DS20100530, DS20100531, DS20100532, DS20100533, DS20100534, DS20100535, DS20100536, DS20100537, DS20100538, DS20100539, DS20100540, DS20100541, DS20100542, DS20100543, DS20100544, DS20100545, DS20100547, DS20100549, DS20100550, DS20100551, DS20100553, DS20100556, DS20100557, DS20100560, DS20100561, DS20100562, DS20100563, DS20100564, DS20100565, DS20100566, DS20100567, DS20100568, DS20100570, DS20100571, DS20100572, DS20100573, DS20100574, DS20100575, DS20100581, DS20100582, DS20100584, DS20100585, DS20100586, DS20100587, DS20100589, DS20100590, DS20100592, DS20100593, DS20100594, DS20100595, DS20100596, DS20100597, DS20100598, DS20100600, DS20100603, DS20100605, DS20100606, DS20100610, DS20100616, DS20100617, DS20100622, DS20100624, DS20100626, DS20100629, DS20100630, DS20100632, DS20100633, DS20100636, DS20100637, DS20100638, DS20100639, DS20100641, DS20100642, DS20100643, DS20100644, DS20100645, DS20100646, DS20100648, DS20100649, DS20100650, DS20100651, DS20100652, DS20100653, DS20100654, DS20100655, DS20100656, DS20100657, DS20100658, DS20100660, DS20100661, DS20100662, DS20100663, DS20100664, DS20100666, DS20100669, DS20100673, DS20100674, DS20100676, DS20100678, DS20100679, DS20100680, DS20100681, DS20100685, DS20100687, DS20100688, DS20100689, DS20100690, DS20100691, DS20100692, DS20100696, DS20100699, DS20100700, DS20100701, DS20100703, DS20100704, DS20100705, DS20100706, DS20100707, DS20100708, DS20100709, DS20100710, DS20100711, DS20100713, DS20100715, DS20100717, DS20100718, DS20100720, DS20100722, DS20100723, DS20100724, DS20100725, DS20100728, DS20100730, DS20100734, DS20100735, DS20100736, DS20100737, DS20100738, DS20100739, DS20100740, DS20100741, DS20100742, DS20100743, DS20100744, DS20100745, DS20100751, DS20100752, DS20100753, DS20100756, DS20100759, DS20100768, DS20100771, DS20100773, DS20100774, DS20100776, DS20100777, DS20100780, DS20100782, DS20100783, DS20100784, DS20100793, DS20100798, DS20100800, DS20100803, DS20100806, DS20100807, DS20100816, DS20100830, DS20100837, and DS20100931.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution to include: US Nationwide and Countries of Canada and Malaysia
  • Description du dispositif
    Ikaria INOMAX DS Drug Delivery System, model 10003. Ikaria 6 Route 173, Clinton, NJ 08809 USA. || The INOMAX DS Delivery System delivers INOMAX (nitric oxide for inhalation) therapy gas into the inspiratory limb of the patient breathing circuit in a way that provides a constant concentration of nitric oxide (NO), as set by the user, to the patient throughout the inspired breath. It uses a specially designed injector module, which enables tracking of the ventilator waveforms and the delivery of a synchronized and proportional dose of NO. It may be used with most ventilators. The INOMAX DS provides continuous integrated monitoring of inspired O2, NO2, and NO, and a comprehensive alarm system.
  • Manufacturer

Manufacturer

  • Adresse du fabricant
    Ikaria Holdings, 6 State Route 173, Clinton NJ 08809
  • Société-mère du fabricant (2017)
  • Source
    USFDA