Retiro De Equipo (Recall) de Device Recall BleaseFocus Anesthesia Workstation and 700/900 Series Ventilators

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Del Mar Reynolds Medical, Ltd..

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    63714
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0565-2013
  • Fecha de inicio del evento
    2012-11-02
  • Fecha de publicación del evento
    2012-12-19
  • Estado del evento
    Terminated
  • País del evento
  • Fecha de finalización del evento
    2013-07-11
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    Gas-machine, anesthesia - Product Code BSZ
  • Causa
    The bleasefocus anesthesia workstation and 700/900 series ventilators were shipped with manuals that describe a secondary o2 supply failure alarm which has not been incorporated into the system. the manuals were prematurely updated for a feature that is not yet available.
  • Acción
    Spacelabs has sent the Urgent -Medical Device Correction-Spacelabs Healthcare BleaseFocus Anesthesia Workstation Blease 700/900 Series Ventilators letter, dated 16 November 2012, to US customers. On November 26, 2012, a customer letter (translated as necessary) was emailed to all international subsidiaries and distributors of record. Customers are advised that the primary alarm will sound only in the event of an O2 supply failure and they will be provided with the corrected user and service manuals that do not reference a secondary O2 supply failure alarm. Customers with questions can call Spacelabs Healthcare at 1-800-522-7025 and select 2 for Technical Support.

Device

  • Modelo / Serial
    Serial numbers for three workstations in the US:  focu-101917; focu-101909; and focu-101881.  Serial numbers for BleaseFocus workstations in other countries:  FOCO-100076, FOCO-100077, FOCO-100078, FOCO-100079, FOCO-100080, FOCO-100081, FOCU-000353, FOCU-000354, FOCU-000355, FOCU-000356, FOCU-000357, FOCU-000364, FOCU-000365, FOCU-000405, FOCU-000406, FOCU-000407, FOCU-000408, FOCU-000409, FOCU-000410, FOCU-000411, FOCU-000412, FOCU-000413, FOCU-000414, FOCU-000415, FOCU-000416, FOCU-000417, FOCU-000418, FOCU-000419, FOCU-000420, FOCU-000421, FOCU-000422, FOCU-000423, FOCU-000424, FOCU-000425, focu-000454, FOCU-000455, FOCU-000456, FOCU-000457, FOCU-000458, FOCU-000459, FOCU-000460, FOCU-000461, FOCU-000462, FOCU-000463, focu-000464, FOCU-000465, FOCU-000466, FOCU-000467, FOCU-000468, FOCU-000469, FOCU-000470, FOCU-000471, FOCU-000472, FOCU-000473, FOCU-000474, FOCU-000475, FOCU-000476, FOCU-000477, FOCU-000478, FOCU-000479, FOCU-000480, FOCU-000481, FOCU-000482, FOCU-000483, FOCU-000484, FOCU-000485, FOCU-000486, FOCU-000487, FOCU-000488, FOCU-000489, FOCU-000490, FOCU-000491, FOCU-000492, FOCU-000493, FOCU-000494, FOCU-000495, FOCU-000496, FOCU-000497, FOCU-000498, FOCU-000499, FOCU-000500, FOCU-000501, FOCU-000502, FOCU-000503, FOCU-000504, FOCU-000505, FOCU-000506, FOCU-000507, FOCU-000508, FOCU-000509, FOCU-000510, FOCU-000511, FOCU-000512, FOCU-000513, FOCU-000514, FOCU-000515, FOCU-000516, FOCU-000517, FOCU-000518, FOCU-000519, FOCU-000520, FOCU-000521, FOCU-000522, FOCU-000523, FOCU-000524, FOCU-000525, FOCU-000526, FOCU-000527, FOCU-000528, FOCU-000529, FOCU-000530, FOCU-000531, FOCU-000532, FOCU-000533, FOCU-000534, FOCU-000535, FOCU-000536, FOCU-000537, FOCU-000538, FOCU-000539, FOCU-000540, FOCU-000541, FOCU-000542, FOCU-000543, FOCU-000544, FOCU-000545, FOCU-000546, FOCU-000547, FOCU-000548, FOCU-000549, FOCU-000550, FOCU-000551, FOCU-000552, FOCU-000553, FOCU-000554, FOCU-000555, FOCU-000556, FOCU-000557, FOCU-000558, FOCU-000562, FOCU-000565, FOCU-000566, FOCU-000567, FOCU-000568, FOCU-000569, FOCU-000570, FOCU-000571, FOCU-000572, FOCU-000573, FOCU-000574, FOCU-000575, FOCU-000576, FOCU-000577, FOCU-000578, focu-000579, focu-000580, FOCU-000581, FOCU-000582, FOCU-000583, FOCU-000584, FOCU-000585, FOCU-000586, FOCU-000587, FOCU-000588, FOCU-000589, FOCU-000590, FOCU-000591, FOCU-000592, FOCU-000593, FOCU-000594, FOCU-000595, FOCU-000596, FOCU-000597, FOCU-000598, FOCU-000599, FOCU-000600, FOCU-000601, FOCU-000602, FOCU-000603, FOCU-000604, FOCU-000605, FOCU-000606, FOCU-000607, FOCU-000608, FOCU-000609, FOCU-000610, FOCU-000611, FOCU-000612, FOCU-000613, FOCU-000614, FOCU-000615, FOCU-000616, FOCU-000617, FOCU-000618, FOCU-000619, FOCU-000620, FOCU-000621, FOCU-000622, FOCU-000623, focu-000624, FOCU-000625, focu-000626, FOCU-000627, FOCU-000628, FOCU-000629, FOCU-000630, FOCU-000631, FOCU-000632, FOCU-000633, FOCU-000634, FOCU-000635, FOCU-000636, FOCU-000637, FOCU-000638, FOCU-000639, FOCU-000640, FOCU-000641, FOCU-000642, FOCU-000643, FOCU-000644, focu-000645, focu-000646, FOCU-000647, focu-000648, focu-000649, FOCU-000650, FOCU-000651, FOCU-000652, FOCU-000653, FOCU-000654, FOCU-000655, FOCU-000656, FOCU-000657, FOCU-000658, FOCU-000659, FOCU-000660, FOCU-000661, FOCU-000662, FOCU-000663, FOCU-000664, FOCU-000665, FOCU-000666, FOCU-000667, FOCU-000668, FOCU-000669, FOCU-000670, FOCU-000671, FOCU-000672, FOCU-000673, FOCU-000674, FOCU-000675, FOCU-000676, FOCU-000677, FOCU-000678, FOCU-000679, FOCU-000680, focu-000681, focu-000682, focu-000683, focu-000684, focu-000685, focu-000686, focu-000687, focu-000688, focu-000689, focu-000690, FOCU-000691, FOCU-000692, FOCU-000693, FOCU-000694, FOCU-000695, FOCU-000696, focu-000697, FOCU-000698, FOCU-000699, FOCU-000700, FOCU-000701, FOCU-000702, FOCU-000703, FOCU-000704, FOCU-000705, FOCU-000706, FOCU-000707, FOCU-000708, FOCU-000709, FOCU-000710, FOCU-000711, FOCU-000712, FOCU-000713, FOCU-000714, FOCU-000715, FOCU-000716, FOCU-000717, FOCU-000718, FOCU-000719, FOCU-000720, FOCU-000721, FOCU-000722, FOCU-000723, FOCU-000724, FOCU-000725, FOCU-000726, FOCU-000727, FOCU-000728, FOCU-000729, focu-000730, focu-000731, focu-000732, FOCU-000733, FOCU-000734, FOCU-000735, FOCU-000736, FOCU-000737, focu-000738, FOCU-000739, focu-000740, FOCU-000741, FOCU-000742, FOCU-000743, FOCU-000750, FOCU-000751, FOCU-000754, FOCU-000755, focu-000756, focu-000757, focu-000758, focu-000759, focu-000760, focu-000761, FOCU-000762, FOCU-000763, FOCU-000764, FOCU-000765, FOCU-000766, FOCU-000767, FOCU-000768, FOCU-000769, FOCU-000770, FOCU-000771, FOCU-000772, FOCU-000773, FOCU-000774, FOCU-000775, FOCU-000776, FOCU-000777, FOCU-000778, FOCU-000779, FOCU-000780, FOCU-000781, FOCU-000782, FOCU-000783, FOCU-000784, FOCU-000785, focu-000786, FOCU-000787, FOCU-000788, FOCU-000789, FOCU-000790, FOCU-000791, FOCU-000792, FOCU-000793, FOCU-000794, FOCU-000795, focu-000796, FOCU-000797, FOCU-000798, FOCU-000799, FOCU-000800, FOCU-000801, FOCU-000802, FOCU-000803, FOCU-000804, focu-000805, FOCU-000806, FOCU-000807, FOCU-000808, focu-000809, FOCU-000812, focu-000813, focu-000814, FOCU-000815, FOCU-000816, FOCU-000817, FOCU-000818, focu-000819, focu-000820, focu-000821, focu-000822, focu-000823, focu-000824, focu-000825, focu-000826, focu-000827, focu-000828, focu-000829, focu-000830, focu-000831, focu-000832, focu-000833, focu-000834, focu-000835, focu-000836, focu-000837, focu-000838, focu-000839, focu-000840, FOCU-000841, FOCU-000842, FOCU-000843, FOCU-000844, FOCU-000845, FOCU-000846, FOCU-000847, FOCU-000848, FOCU-000849, FOCU-000850, FOCU-000853, FOCU-000854, focu-00767, focu-00768, FOCU-100001, FOCU-100001, FOCU-100002, focu-100003, FOCU-100004, focu-100005, focu-100006, focu-100007, focu-100008, focu-100009, focu-100016, focu-100017, focu-100018, focu-100019, focu-100020, focu-100021, focu-100022, focu-100023, focu-100024, focu-100025, focu-100026, focu-100027, focu-100028, focu-100031, focu-100032, focu-100033, focu-100034, focu-100035, focu-100036, focu-100037, focu-100038, focu-100039, FOCU-100040, FOCU-100041, FOCU-100042, FOCU-100043, FOCU-100044, FOCU-100045, FOCU-100046, FOCU-100047, FOCU-100048, FOCU-100049, FOCU-100050, FOCU-100051, FOCU-100052, focu-100053, focu-100054, focu-100055, focu-100056, FOCU-100057, FOCU-100058, FOCU-100059, FOCU-100060, focu-100069, focu-100070, focu-100071, focu-100072, focu-100073, focu-100074, focu-100075, focu-100082, focu-100083, focu-100084, FOCU-100085, FOCU-100087, FOCU-100088, FOCU-100089, FOCU-100090, FOCU-100091, FOCU-100092, FOCU-100093, FOCU-100094, FOCU-100095, FOCU-100096, FOCU-100097, FOCU-100098, focu-100099, focu-100100, focu-100101, focu-100102, focu-100103, focu-100104, focu-100105, focu-100106, focu-100107, focu-100108, focu-100109, focu-100110, FOCU-100111, focu-100112, FOCU-100113, focu-100114, FOCU-100115, FOCU-100116, FOCU-100117, FOCU-100118, FOCU-100119, FOCU-100120, FOCU-100121, FOCU-100122, FOCU-100123, FOCU-100124, FOCU-100125, FOCU-100126, FOCU-100127, FOCU-100128, FOCU-100129, FOCU-100130, FOCU-100131, FOCU-100132, FOCU-100133, FOCU-100134, FOCU-100135, FOCU-100136, FOCU-100137, FOCU-100138, FOCU-100139, FOCU-100140, FOCU-100141, FOCU-100142, FOCU-100143, FOCU-100144, FOCU-100145, FOCU-100146, FOCU-100147, FOCU-100148, FOCU-100149, FOCU-100150, FOCU-100151, FOCU-100152, FOCU-100153, FOCU-100154, FOCU-100155, FOCU-100156, focu-100157, focu-100158, focu-100159, focu-100160, focu-100161, focu-100162, focu-100163, FOCU-100164, FOCU-100165, focu-100179, focu-100180, focu-100181, focu-100182, focu-100183, focu-100184, focu-100185, focu-100186, focu-100187, focu-100188, focu-100189, focu-100190, focu-100191, focu-100192, FOCU-100193, FOCU-100194, FOCU-100195, FOCU-100196, FOCU-100197, FOCU-100198, FOCU-100199, FOCU-100200, FOCU-100201, FOCU-100202, FOCU-100203, FOCU-100204, FOCU-100205, FOCU-100206, FOCU-100207, FOCU-100208, FOCU-100209, FOCU-100210, FOCU-100211, focu-100212, focu-100213, focu-100214, focu-100215, focu-100216, focu-100217, FOCU-100218, FOCU-100219, focu-100220, focu-100221, focu-100222, focu-100223, focu-100224, focu-100225, focu-100226, FOCU-100227, FOCU-100228, FOCU-100229, FOCU-100230, FOCU-100231, focu-100232, focu-100233, focu-100234, focu-100235, focu-100236, FOCU-100237, FOCU-100238, FOCU-100239, FOCU-100240, FOCU-100241, FOCU-100242, FOCU-100243, focu-100244, FOCU-100245, FOCU-100246, FOCU-100247, FOCU-100248, FOCU-100249, FOCU-100250, FOCU-100251, FOCU-100252, FOCU-100253, FOCU-100254, FOCU-100255, FOCU-100256, FOCU-100257, FOCU-100258, FOCU-100259, FOCU-100260, FOCU-100261, FOCU-100262, FOCU-100263, FOCU-100264, FOCU-100265, FOCU-100266, FOCU-100267, FOCU-100268, FOCU-100269, FOCU-100270, FOCU-100271, FOCU-100272, FOCU-100273, FOCU-100274, FOCU-100275, focu-100276, focu-100277, focu-100278, focu-100279, focu-100280, focu-100281, focu-100282, focu-100283, focu-100284, focu-100285, FOCU-100286, FOCU-100287, focu-100288, focu-100289, focu-100290, FOCU-100291, FOCU-100292, focu-100293, focu-100294, focu-100295, focu-100296, focu-100297, focu-100298, focu-100299, focu-100300, focu-100301, focu-100302, focu-100303, focu-100304, focu-100305, focu-100306, focu-100307, focu-100308, focu-100309, focu-100310, focu-100311, focu-100312, focu-100313, focu-100314, focu-100315, FOCU-100316, FOCU-100317, FOCU-100318, FOCU-100319, focu-100320, focu-100321, focu-100322, focu-100323, focu-100324, focu-100325, focu-100326, focu-100327, focu-100328, focu-100329, FOCU-100330, focu-100331, focu-100332, focu-100333, focu-100334, focu-100335, focu-100336, focu-100337, focu-100338, focu-100339, focu-100340, focu-100341, focu-100342, focu-100343, focu-100344, focu-100345, focu-100346, focu-100347, focu-100348, FOCU-100349, focu-100350, focu-100351, focu-100352, focu-100353, focu-100354, focu-100355, focu-100356, focu-100357, focu-100358, focu-100359, focu-100360, focu-100361, focu-100362, focu-100363, focu-100364, focu-100365, focu-100366, focu-100367, focu-100368, focu-100369, focu-100370, focu-100371, focu-100372, focu-100373, focu-100374, focu-100375, focu-100376, focu-100377, focu-100378, focu-100379, focu-100380, focu-100381, focu-100382, focu-100383, focu-100384, focu-100385, focu-100386, focu-100387, focu-100388, focu-100389, focu-100390, focu-100391, focu-100392, focu-100393, focu-100394, focu-100395, focu-100396, focu-100397, focu-100398, focu-100399, focu-100400, focu-100401, focu-100402, focu-100403, focu-100404, focu-100405, focu-100406, focu-100407, focu-100408, focu-100409, focu-100410, focu-100411, FOCU-100412, FOCU-100413, FOCU-100414, FOCU-100415, FOCU-100416, FOCU-100417, FOCU-100418, FOCU-100419, focu-100420, focu-100421, focu-100422, focu-100423, focu-100424, focu-100425, focu-100426, focu-100427, focu-100428, focu-100429, focu-100430, focu-100431, focu-100432, focu-100433, focu-100434, focu-100435, focu-100436, focu-100437, focu-100438, focu-100439, focu-100440, focu-100441, focu-100442, focu-100443, focu-100444, focu-100445, focu-100446, focu-100447, focu-100448, focu-100449, 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focu-101663, focu-101664, focu-101665, focu-101666, focu-101667, focu-101668, focu-101669, focu-101670, focu-101671, focu-101672, focu-101673, focu-101674, focu-101675, focu-101676, focu-101677, focu-101678, focu-101679, focu-101680, focu-101681, focu-101682, FOCU-101683, focu-101684, focu-101685, FOCU-101686, FOCU-101687, FOCU-101688, FOCU-101689, FOCU-101690, FOCU-101691, FOCU-101692, FOCU-101693, FOCU-101694, FOCU-101695, focu-101698, focu-101699, focu-101700, focu-101701, focu-101702, FOCU-101704, FOCU-101705, FOCU-101706, FOCU-101707, FOCU-101708, FOCU-101709, FOCU-101710, FOCU-101711, FOCU-101712, FOCU-101713, FOCU-101714, FOCU-101715, focu-101716, focu-101717, focu-101718, focu-101719, focu-101720, focu-101721, focu-101722, focu-101723, focu-101724, focu-101725, focu-101726, focu-101727, focu-101728, focu-101729, FOCU-101730, FOCU-101731, FOCU-101732, FOCU-101733, FOCU-101734, FOCU-101735, FOCU-101736, FOCU-101737, FOCU-101738, FOCU-101739, FOCU-101740, FOCU-101741, FOCU-101742, FOCU-101743, FOCU-101744, FOCU-101745, FOCU-101746, FOCU-101747, focu-101748, FOCU-101749, focu-101750, FOCU-101751, FOCU-101752, FOCU-101753, FOCU-101754, FOCU-101755, FOCU-101756, FOCU-101757, FOCU-101758, FOCU-101759, FOCU-101760, FOCU-101761, FOCU-101762, FOCU-101763, FOCU-101764, FOCU-101765, FOCU-101766, FOCU-101767, FOCU-101768, FOCU-101769, FOCU-101770, FOCU-101771, FOCU-101772, FOCU-101773, FOCU-101774, FOCU-101775, FOCU-101776, FOCU-101777, FOCU-101778, focu-101779, FOCU-101780, FOCU-101781, FOCU-101782, FOCU-101783, FOCU-101784, FOCU-101785, FOCU-101786, FOCU-101787, FOCU-101788, FOCU-101789, FOCU-101790, FOCU-101791, FOCU-101792, FOCU-101793, FOCU-101794, FOCU-101800, FOCU-101801, FOCU-101802, FOCU-101803, FOCU-101804, FOCU-101805, FOCU-101806, FOCU-101807, FOCU-101808, FOCU-101809, FOCU-101810, focu-101811, focu-101812, focu-101813, FOCU-101814, FOCU-101815, FOCU-101816, FOCU-101817, FOCU-101818, FOCU-101819, FOCU-101820, focu-101821, focu-101822, focu-101823, FOCU-101827, FOCU-101828, FOCU-101829, FOCU-101830, focu-101831, focu-101832, focu-101833, focu-101834, focu-101835, focu-101836, focu-101837, focu-101838, focu-101839, focu-101840, focu-101841, FOCU-101842, FOCU-101843, FOCU-101844, focu-101845, FOCU-101846, FOCU-101847, FOCU-101848, FOCU-101849, FOCU-101850, FOCU-101851, FOCU-101852, FOCU-101853, FOCU-101854, FOCU-101855, FOCU-101856, FOCU-101857, FOCU-101858, FOCU-101859, FOCU-101860, focu-101861, focu-101862, focu-101863, focu-101864, focu-101865, FOCU-101866, FOCU-101867, FOCU-101868, FOCU-101869, FOCU-101870, FOCU-101871, FOCU-101872, FOCU-101873, FOCU-101874, FOCU-101875, FOCU-101876, FOCU-101877, FOCU-101878, FOCU-101879, FOCU-101880, FOCU-101882, FOCU-101883, FOCU-101884, FOCU-101885, FOCU-101886, FOCU-101887, FOCU-101888, FOCU-101889, FOCU-101890, focu-101891, focu-101892, focu-101893, focu-101894, focu-101895, focu-101896, focu-101897, FOCU-101898, FOCU-101899, FOCU-101900, FOCU-101901, FOCU-101902, FOCU-101903, FOCU-101904, FOCU-101905, FOCU-101906, FOCU-101907, FOCU-101908, FOCU-101910, FOCU-101911, FOCU-101912, FOCU-101913, FOCU-101914, FOCU-101915, focu-101926, focu-101927, FUCU-000426, FUCU-000427, FUCU-000428, FUCU-000429, FUCU-000430, FUCU-000431, FUCU-000432, FUCU-000433, FUCU-000434, FUCU-000435, FUCU-000436, FUCU-000437, FUCU-000438, FUCU-000439, FUCU-000440, FUCU-000441, FUCU-000442, FUCU-000443, FUCU-000444, FUCU-000445, FUCU-000446, FUCU-000447, FUCU-000448, FUCU-000449, FUCU-000450, FUCU-000451, FUCU-000452, FUCU-000453, FUCU-000744, FUCU-000745, FUCU-000746, FUCU-000747, FUCU-000748, FUCU-000749, FUCU-100166, FUCU-100167, FUCU-100168, FUCU-100169, FUCU-100170, FUCU-100171, FUCU-100172, FUCU-100173, FUCU-100174, FUCU-100175, FUCU-100176, FUCU-100177, and FUCU-100178.    Serial numbers for the ventilators in other countries:  VENT-001034, VENT-001036, VENT-001037, VENT-001038, VENT-001039, VENT-001040, VENT-001041, VENT-001042, VENT-001043, VENT-001044, VENT-001045, VENT-001046, VENT-001048, VENT-001049, VENT-001050, VENT-001051, VENT-001052, VENT-001053, VENT-001054, VENT-001055, VENT-001056, VENT-001057, VENT-001058, VENT-001059, VENT-001060, VENT-001061, VENT-001062, VENT-001063, VENT-001064, VENT-001065, VENT-001067, VENT-001069, VENT-001070, VENT-001071, VENT-001072, VENT-001073, VENT-001074, VENT-001075, VENT-001077, VENT-001078, VENT-001080, VENT-001082, VENT-001083, VENT-001084, VENT-001085, VENT-001086, VENT-001087, VENT-001089, VENT-001090, VENT-001096, VENT-001097, VENT-001098, VENT-001113, VENT-001114, VENT-001171, VENT-001172, VENT-001173, VENT-001174, VENT-001175, VENT-001176, VENT-001177, vent-001179, vent-001180, vent-001181, vent-001182, vent-001183, vent-001202, vent-001203, VENT-001286, VENT-001288, VENT-001289, VENT-001290, VENT-001321, VENT-001322, VENT-001323, VENT-001324, VENT-001336, vent-001339, VENT-001340, vent-001341, VENT-001342, VENT-001346, VENT-001456, vent-001458, VENT-001469, VENT-001550, VENT-001552, VENT-001557, VENT-001558, VENT-001559, VENT-001560, VENT-001567, VENT-001568, VENT-001569, VENT-001570, VENT-001571, VENT-001572, VENT-001620, VENT-001753, vent-001856, vent-001875, VENT-001889, VENT-001893, VENT-001896, VENT-001898, VENT-001933, VENT-001934, VENT-001935, VENT-001937, VENT-001938, VENT-001939, VENT-001940, VENT-001941, VENT-001955, VENT-001958, VENT-001959, vent-001966, VENT-001978, vent-001979, VENT-001981, vent-001983, VENT-001984, VENT-001989, VENT-001993, VENT-001994, VENT-001996, VENT-001997, VENT-001998, VENT-001999, VENT-002002, VENT-002004, VENT-002005, VENT-002006, VENT-002007, VENT-002009, VENT-002010, VENT-002011, VENT-002012, VENT-002013, VENT-002014, VENT-002015, VENT-002016, VENT-002017, VENT-002019, VENT-002020, VENT-002022, VENT-002023, VENT-002024, VENT-002026, VENT-002031, VENT-002033, VENT-002034, VENT-002036, VENT-002037, VENT-002038, VENT-002039, VENT-002040, VENT-002042, VENT-002046, VENT-002052, VENT-002068, VENT-002071, VENT-002107, VENT-002110, VENT-002111, VENT-002112, VENT-002113, VENT-002114, VENT-002116, VENT-002117, VENT-002119, VENT-002123, VENT-002124, VENT-002125, VENT-002126, VENT-002127, VENT-002128, VENT-002129, VENT-002130, VENT-002131, VENT-002132, VENT-002133, VENT-002136, VENT-002137, VENT-002138, VENT-002140, VENT-002141, VENT-002142, VENT-002143, VENT-002144, VENT-002145, VENT-002146, VENT-002151, VENT-002152, VENT-002153, VENT-002154, VENT-002155, VENT-002157, VENT-002163, VENT-002167, VENT-002170, VENT-002172, VENT-002173, VENT-002174, vent-002175, vent-002179, vent-002180, vent-002181, vent-002182, vent-002183, vent-002184, vent-002187, vent-002189, vent-002190, vent-002191, vent-002192, vent-002193, vent-002194, vent-002195, vent-002196, vent-002197, vent-002198, vent-002199, vent-002200, vent-002217, vent-002218, vent-002260, vent-002261, vent-002262, vent-002263, vent-002264, vent-002265, vent-002266, vent-002267, vent-002268, vent-002269, vent-002279, vent-002280, vent-002281, vent-002282, vent-002283, vent-002284, vent-002285, vent-002286, vent-002287, vent-002288, vent-002289, VENT-002328, VENT-002330, VENT-002331, VENT-002341, vent-002351, vent-002355, VENT-002358, vent-002431, vent-002432, vent-002438, vent-002440, vent-002441, vent-002442, vent-002443, vent-002444, vent-002445, vent-002446, vent-002448, VENT-002452, VENT-002453, VENT-002454, VENT-002455, VENT-002458, VENT-002459, VENT-002460, VENT-002461, vent-002462, VENT-002463, VENT-002465, VENT-002466, VENT-002468, vent-002469, vent-002470, VENT-002471, vent-002472, vent-002473, vent-002474, vent-002476, vent-002478, vent-002479, vent-002482, vent-002484, vent-002485, vent-002486, vent-002487, vent-002488, vent-002489, vent-002490, vent-002492, vent-002493, vent-002494, vent-002495, vent-002496, vent-002497, vent-002498, vent-002499, vent-002500, VENT-002501, vent-002502, VENT-002505, VENT-002506, VENT-002508, VENT-002509, VENT-002510, VENT-002511, VENT-002512, VENT-002513, VENT-002514, VENT-002516, VENT-002518, VENT-002519, VENT-002520, VENT-002526, VENT-002527, VENT-002528, VENT-002530, VENT-002531, VENT-002532, VENT-002535, VENT-002536, VENT-002538, VENT-002541, VENT-002542, VENT-002545, vent-002546, vent-002547, VENT-002550, VENT-002551, VENT-002552, VENT-002554, VENT-002555, VENT-002556, VENT-002568, VENT-002569, VENT-002570, VENT-002571, VENT-002572, VENT-002573, VENT-002574, VENT-002575, VENT-002578, VENT-002579, VENT-002585, VENT-002586, vent-002595, vent-002601, VENT-002602, vent-002603, VENT-002604, VENT-002605, VENT-002607, VENT-002608, VENT-002609, VENT-002610, VENT-002611, VENT-002667, VENT-002670, VENT-002671, VENT-002672, VENT-002673, VENT-002674, VENT-002675, VENT-002676, VENT-002679, VENT-002680, VENT-002681, VENT-002682, VENT-002683, VENT-002684, VENT-002688, VENT-002689, VENT-002694, VENT-002695, VENT-002696, VENT-002708, VENT-002711, VENT-002712, VENT-002713, VENT-002714, VENT-002715, VENT-002716, VENT-002717, VENT-002718, VENT-002719, VENT-002720, VENT-002721, VENT-002722, VENT-002724, VENT-002725, VENT-002726, VENT-002729, VENT-002730, VENT-002732, VENT-002733, VENT-002734, VENT-002735, VENT-002736, VENT-002737, VENT-002739, VENT-002740, VENT-002741, VENT-002742, VENT-002743, VENT-002744, vent-002745, VENT-002746, vent-002747, VENT-002748, vent-002749, vent-002750, vent-002751, vent-002752, vent-002753, vent-002754, vent-002755, vent-002756, VENT-002757, vent-002758, vent-002759, vent-002760, VENT-002761, VENT-002762, VENT-002763, VENT-002764, VENT-002765, VENT-002766, VENT-002767, VENT-002768, VENT-002769, VENT-002770, VENT-002771, VENT-002772, VENT-002773, VENT-002774, VENT-002775, VENT-002776, VENT-002777, VENT-002779, VENT-002780, VENT-002783, VENT-002784, VENT-002785, VENT-002786, VENT-002787, VENT-002788, VENT-002789, VENT-002790, VENT-002791, VENT-002793, VENT-002794, VENT-002795, VENT-002796, VENT-002798, VENT-002799, VENT-002800, vent-002801, vent-002832, vent-002857, vent-002868, vent-002873, vent-002896, vent-002909, vent-002916, vent-003005, vent-003006, vent-003007, vent-003008, vent-003009, vent-003010, VENT-003016, vent-003069, vent-003140, vent-003141, vent-003142, vent-003148, vent-003149, vent-003150, vent-003151, vent-003153, vent-003154, vent-003155, vent-003195, vent-003202, vent-003203, vent-003204, vent-003205, vent-003206, vent-003207, vent-003208, vent-003209, vent-003210, vent-003211, vent-003212, vent-003215, vent-003219, vent-003222, vent-003223, vent-003224, vent-003240, vent-003241, vent-003272, vent-003278, vent-003280, vent-003281, vent-003282, vent-003283, vent-003290, vent-003324, vent-003331, vent-003343, vent-003344, vent-003346, vent-003348, vent-003351, vent-003358, vent-003448, vent-003619, vent-003630, vent-003631, vent-003632, vent-003634, vent-003664, vent-003670, vent-003671, vent-003672, vent-003673, vent-003675, vent-003676, vent-003678, vent-003679, vent-003680, vent-003681, vent-003682, vent-003683, vent-003684, vent-003685, vent-003686, vent-003687, vent-003688, vent-003691, vent-003692, vent-003693, vent-003697, vent-003699, vent-003704, vent-003706, vent-003719, vent-003722, vent-003723, vent-003727, vent-003728, vent-003729, vent-003876, vent-003882, vent-003884, vent-003885, vent-004025, vent-004036, vent-004172, vent-004179, vent-004200, vent-004203, vent-004204, vent-004206, vent-004225, vent-004229, vent-004230, vent-004238, vent-004243, vent-004275, vent-004276, vent-004277, vent-004278, vent-004279, vent-004281, vent-004282, vent-004283, vent-004284, vent-004285, vent-004286, vent-004287, vent-004288, vent-004291, vent-004295, vent-004297, vent-004298, vent-004301, vent-004303, vent-004304, vent-004306, vent-004307, vent-004308, vent-004310, vent-004311, vent-004313, vent-004314, vent-004315, vent-004316, vent-004317, vent-004318, vent-004319, vent-004320, vent-004321, vent-004322, vent-004323, vent-004324, vent-004325, vent-004326, vent-004327, vent-004328, vent-004329, vent-004330, vent-004331, vent-004332, vent-004333, vent-004334, vent-004335, vent-004337, vent-004342, vent-004611, vent-004612, vent-004613, vent-004616, vent-004617, vent-004619, vent-004620, vent-004762, vent-004767, vent-004770, vent-004771, vent-004773, vent-004776, vent-004779, vent-004786, vent-004787, vent-004790, vent-004794, vent-004798, vent-004800, vent-004801, vent-004802, vent-004803, vent-004806, vent-004807, vent-004808, vent-004809, vent-004810, vent-004811, vent-004812, vent-004813, vent-004816, vent-004817, vent-004818, vent-004819, vent-004820, vent-004821, vent-004824, vent-004825, vent-004826, vent-004827, vent-004828, vent-004829, vent-004830, vent-004831, vent-004835, vent-004836, vent-004837, vent-004838, vent-004839, vent-004840, vent-004842, vent-004843, vent-004845, vent-004846, vent-004850, vent-004853, vent-004926, vent-004927, vent-004928, vent-004930, vent-004931, vent-004932, vent-004933, vent-004934, vent-004935, vent-004937, vent-004938, vent-004939, vent-004940, vent-004941, vent-004942, vent-004943, vent-004944, vent-004948, vent-004951, vent-004953, vent-004956, vent-004959, vent-004960, vent-004961, vent-004965, vent-004968, vent-004969, vent-004971, vent-004972, vent-004973, vent-004974, vent-004975, vent-004976, VENT-004977, VENT-004978, VENT-004979, VENT-004980, VENT-004981, VENT-004982, VENT-004983, vent-004984, VENT-004985, VENT-004986, VENT-004987, VENT-004988, VENT-004989, VENT-004990, VENT-004991, VENT-004992, VENT-004993, VENT-004994, VENT-004995, VENT-004996, VENT-004999, VENT-005000, VENT-005008, VENT-005009, VENT-005010, VENT-005011, VENT-005012, VENT-005013, VENT-005015, VENT-005017, VENT-005018, VENT-005019, VENT-005020, VENT-005022, VENT-005023, VENT-005025, VENT-005032, VENT-005033, VENT-005034, VENT-005035, VENT-005037, VENT-005039, VENT-005042, VENT-005043, VENT-005044, VENT-005045, VENT-005046, VENT-005047, VENT-005050, VENT-005054, VENT-005057, VENT-005070, VENT-005071, VENT-005072, VENT-005073, VENT-005074, VENT-005075, VENT-005076, VENT-005077, VENT-005078, VENT-005080, VENT-005081, VENT-005082, VENT-005083, VENT-005084, VENT-005086, VENT-005087, VENT-005088, VENT-005104, vent-005107, vent-005108, vent-005109, vent-005110, vent-005111, vent-005112, VENT-005114, VENT-005116, VENT-005118, VENT-005119, VENT-005121, VENT-005122, VENT-005123, VENT-005127, VENT-005129, VENT-005137, VENT-005138, VENT-005139, VENT-005140, VENT-005142, VENT-005143, VENT-005147, VENT-005148, VENT-005149, VENT-005150, VENT-005151, VENT-005152, VENT-005153, VENT-005154, VENT-005155, VENT-005160, VENT-005161, VENT-005165, VENT-005166, VENT-005167, VENT-005168, VENT-005169, VENT-005171, VENT-005179, VENT-005307, VENT-005403, VENT-005407, VENT-005574, VENT-005585, VENT-005586, VENT-005587, VENT-005589, VENT-005590, VENT-005591, vent-005771, vent-005772, vent-005773, vent-005774, vent-005775, VENT-005783, VENT-005784, VENT-005785, VENT-005786.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution--USA (nationwide) including states of North Carolina and Oklahoma and the countries of Algeria, Argentina, Bahrain, Bangladesh, Bolivia, Chile, China, Columbia, Dominican Republic, Ecuador, Egypt, Finland, Ghana, Great Britian, Guatemala, Honduras, Hong Kong, India, Indonesia, Iraq, Jamaica, Jordan, Lebanon, Libya, Malaysia, Mauritius, Mexico, Moldova, Nepal, Netherlands, New Zealand, Nicaragua, Nigeria, Pakistan, Palestine, Paraguay, Peru, Philippines, Portugal, Saudi Arabia, Singapore, South Africa, Spain, Sri Lanka, Sudan, Taiwan, Thailand, Trinidad and Tobago, Turkey, United Arab Emirates , Uruguay, Venezuela, and Vietnam.
  • Descripción del producto
    BleaseFocus Anesthesia Workstation and 700/900 Series Ventilators are anesthesia gas machine. || In most cases, the customer ordered both a BleaseFocus anesthesia workstation and a 700/900 ventilator. In some cases, the customer may order a 700/900 stand-alone ventilator would could be used with a BleaseFocus anesthesia workstation at a later date.
  • Manufacturer

Manufacturer

  • Dirección del fabricante
    Del Mar Reynolds Medical, Ltd., 1-2 Harforde Ct., Foxholes, Business Park, Hertford United Kingdom
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA