Del Mar Reynolds Medical, Ltd.

There is no Serial Numbers for 169 Kits. Serial Numbers for 519 units:  12038, 32288, 32300, 32302, 32327, 32329, 32330, 32389, 32410, 32411, 32415, 32417, 32418, 32470, 32471, 32472, 32473, 32474, 32475, 32476, 32478, 32479, 32480, 32481, 32482, 32483, 32484, 32485, 32486, 32487, 32488, 32532, 32546, 32547, 32548, 32549, 32550, 32551, 32552, 32553, 32554, 32557, 32558, 32561, 32567, 32568, 32569, 32570, 32648, 32649, 32650, 32651, 32652, 32653, 32655, 32656, 32657, 32658, 32659, 32676, 32677, 32678, 32679, 32680, 32681, 32682, 32683, 32684, 32686, 32687, 32712, 32713, 32714, 32715, 32716, 32717, 32718, 32719, 32720, 32721, 32722, 32723, 32726, 32742, 32759, 32790, 32791, 32797, 32798, 32799, 32800, 32801, 32802, 32803, 32804, 32805, 32806, 32814, 32821, 32822, 32823, 32824, 32860, 32861, 32862, 32863, 32864, 32865, 32866, 32867, 32868, 32869, 32870, 32871, 32872, 32873, 32877, 32878, 32880, 32881, 32944, 32945, 32946, 32947, 32948, 32949, 32950, 32951, 32952, 32954, 32955, 32956, 32957, 32958, 32959, 32960, 32961, 32963, 32977, 32979, 32980, 32982, 32983, 32984, 32986, 32987, 32989, 32990, 32991, 32992, 32993, 32994, 32995, 33015, 33017, 33058, 33095, 33096, 33097, 33098, 33099, 33100, 33101, 33102, 33103, 33104, 33105, 33106, 33107, 33108, 33113, 33114, 33115, 33116, 33117, 33118, 33119, 33120, 33121, 33122, 33123, 33124, 33132, 33135, 33158, 33159, 33160, 33161, 33162, 33164, 33165, 33166, 33167, 33184, 33185, 33186, 33188, 33189, 33190, 33200, 33201, 33213, 33219, 33221, 33240, 33241, 33242, 33243, 33244, 33245, 33254, 33255, 33257, 33258, 33259, 33260, 33261, 33262, 33263, 33264, 33265, 33267, 33268, 33269, 33270, 33322, 33323, 33324, 33326, 33327, 33328, 33329, 33330, 33336, 33337, 33338, 33339, 33343, 33347, 33348, 33352, 33355, 33386, 33387, 33388, 33391, 33392, 33393, 33394, 33396, 9310, 9520, 9885, 9933, 9934, IMP-002054, IMP-005010, IMP-005011, IMP-005013, IMP-005025, IMP-005027, IMP-005028, IMP-005029, IMP-005030, IMP-005031, IMP-005035, IMP-005036, IMP-005038, IMP-005039, IMP-005042, IMP-005043, IMP-005045, IMP-005046, IMP-005048, IMP-005049, IMP-005050, IMP-005062, IMP-005063, IMP-005065, IMP-005066, IMP-005068, IMP-005073, IMP-005077, IMP-005078, IMP-005087, IMP-005090, IMP-005091, IMP-005092, IMP-005094, IMP-005102, IMP-005108, IMP-005110, IMP-005111, IMP-005115, IMP-005141, IMP-005147, IMP-005151, IMP-005152, IMP-005160, IMP-005162, IMP-005165, IMP-005176, IMP-005218, IMP-005219, IMP-005237, IMP-005238, IMP-005253, IMP-005254, IMP-005258, LIFE-025878, LIFE-027365, LIFE-027527, LIFE-027528, LIFE-027866, LIFE-028314, LIFE-029149, LIFE-029150, LIFE-029718, LIFE-029719, LIFE-032784, LIFE-033181, LIFE-033791, PATH-000100, PATH-000101, PATH-000102, PATH-000103, PATH-000104, PATH-000105, PATH-000106, PATH-000107, PATH-006004, PATH-006005, PATH-006006, PATH-006007, PATH-006018, PATH-006019, PATH-006020, PATH-006039, PATH-006040, PATH-006041, PATH-006042, PATH-006043, PATH-006044, PATH-006045, PATH-006068, PATH-006069, PATH-006070, PATH-006071, PATH-006072, PATH-006073, PATH-006074, PATH-006075, PATH-006077, PATH-006099, PATH-006101, PATH-006102, PATH-006103, PATH-006104, PATH-006105, PATH-006106, PATH-006108, PATH-006109, PATH-006110, PATH-006112, PATH-006113, PATH-006114, PATH-006115, PATH-006120, PATH-006132, PATH-006158, PATH-006159, PATH-006160, PATH-006161, PATH-006162, PATH-006163, PATH-006164, PATH-006165, PATH-006166, PATH-006175, PATH-006182, PATH-006183, PATH-006184, PATH-006186, PATH-006188, PATH-006190, PATH-006237, PATH-006238, PATH-006239, PATH-006250, PATH-006251, PATH-006252, PATH-006253, PATH-006254, PATH-006255, PATH-006256, PATH-006258, PATH-006259, PATH-006299, PATH-006300, PATH-006301, PATH-006302, PATH-006306, PATH-006309, PATH-006314, PATH-006315, PATH-006316, PATH-006317, PATH-006318, PATH-006319, PATH-006320, PATH-006321, PATH-006322, PATH-006323, PATH-006324, PATH-006325, PATH-006326, PATH-006327, PATH-006328, PATH-006329, PATH-006332, PATH-006333, PATH-006344, PATH-006350, PATH-006351, PATH-006353, PATH-006382, PATH-006407, PATH-006409, PATH-006410, PATH-006447, PATH-006448, PATH-006451, PATH-006452, PATH-006471, PATH-006485, PATH-006486, PATH-006487, PATH-006488, PATH-006489, PATH-006490, PATH-006502, PATH-006505, PATH-006506, PATH-006522, PATH-006523, PATH-006524, PATH-006525, PATH-006526, PATH-006527, PATH-006528, PATH-006531, PATH-006533, PATH-006537, PATH-006538, PATH-006542, PATH-006543, PATH-006544, PATH-006545, PATH-006572, PATH-006573, PATH-006574, PATH-006602, PATH-006603, PATH-006604, PATH-006605, PATH-006606, PATH-006607, PATH-006608, PATH-006609, PATH-006610, PATH-006611, PATH-006612, PATH-006613, PATH-006614, PATH-006615, PATH-006630, PATH-006631, PATH-006632, PATH-006638, PATH-006650, PATH-006651, PATH-006652, PATH-006662, PATH-006663, PATH-006664, PATH-006665, PATH-006666, PATH-006667, PATH-006698, PATH-006712, PATH-006713, PATH-006714, PATH-006715, PATH-006716, PATH-006717, PATH-006735, PATH-006736, PATH-006738, PATH-006739, PATH-006740, PATH-006741, PATH-006742, PATH-006743, PATH-006744, PATH-006774, PATH-006830, PATH-006831, PATH-006853, PATH-006858, PATH-006859, PATH-006860, PATH-006861, PATH-006862, PATH-006872, PATH-006873, PATH-006874, PATH-006877, PATH-006878, PATH-006984.   4 additional serial numbers were added 6/5/12 - PATH-006332, PATH-006333, PATH-006350, and PATH-006351.

Anesthesiology Devices

2

No

Worldwide Distribution-USA (nationwide) including the states of AR, CA, CO, CT, FL, GA, KY, LA, MA, MD, MI, MN, NC, NY, OH, TN, TX, UT, WV, and PUERTO RICO and the countries of AUSTRIA, BELGIUM, CHILE, CHINA, COLOMBIA, COSTA RICA, DENMARK, FINLAND, FRANCE, GERMANY, GREECE, HONDURAS, HONG KONG, HUNGARY, INDIA, ISRAEL, ITALY, KUWAIT, MALTA, NETHERLANDS, NEW ZEALAND, NORWAY, OMAN, POLAND, PORTUGAL, RUSSIAN FEDERATION, SAUDI ARABIA, SINGAPORE, Slovakia, SPAIN, SWEDEN, SWITZERLAND, TURKEY, UNITED ARAB EMIRATES, and UNITED KINGDOM

Lifescreen Apnea is Lifescreen ECG Screening System, Version 3.31. || Lifescreen Apnea is indicated for screening adults for the probability that they suffer from obstructive sleep apnea, mixed apnea or hypopnea, in order to evaluate the necessity for a polysomonographic examination. The ECG recording may be obtained at any location specified by a physician including home, hospital or clinic. Subjects screened for sleep apnea should have periods of sleep of at least 4 hours duration during which the ECG is predominantly sinus rhythm in nature.

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, 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FOCU-101425, FOCU-101426, FOCU-101427, FOCU-101428, FOCU-101429, FOCU-101430, FOCU-101431, FOCU-101432, FOCU-101433, FOCU-101434, FOCU-101435, FOCU-101436, FOCU-101437, FOCU-101438, FOCU-101439, FOCU-101440, FOCU-101441, FOCU-101442, FOCU-101443, FOCU-101444, FOCU-101445, FOCU-101446, FOCU-101447, FOCU-101448, FOCU-101449, FOCU-101450, FOCU-101451, FOCU-101452, FOCU-101453, FOCU-101454, FOCU-101455, FOCU-101456, FOCU-101457, FOCU-101458, FOCU-101459, FOCU-101460, FOCU-101461, FOCU-101462, FOCU-101463, FOCU-101464, FOCU-101465, FOCU-101468, FOCU-101469, FOCU-101470, FOCU-101471, FOCU-101472, FOCU-101473, FOCU-101474, FOCU-101475, FOCU-101476, FOCU-101477, FOCU-101478, FOCU-101479, FOCU-101480, FOCU-101481, FOCU-101482, FOCU-101483, FOCU-101484, FOCU-101485, FOCU-101486, FOCU-101491, FOCU-101492, FOCU-101493, FOCU-101494, FOCU-101495, FOCU-101496, FOCU-101497, FOCU-101498, FOCU-101499, FOCU-101500, FOCU-101501, FOCU-101502, focu-101504, FOCU-101505, focu-101506, focu-101507, FOCU-101508, FOCU-101509, FOCU-101510, FOCU-101511, FOCU-101512, FOCU-101513, FOCU-101514, FOCU-101515, FOCU-101516, FOCU-101517, FOCU-101518, FOCU-101519, FOCU-101520, FOCU-101521, FOCU-101522, FOCU-101523, FOCU-101524, FOCU-101525, FOCU-101526, FOCU-101527, FOCU-101528, FOCU-101529, FOCU-101530, FOCU-101531, FOCU-101532, FOCU-101533, FOCU-101534, FOCU-101535, FOCU-101536, FOCU-101537, FOCU-101538, FOCU-101539, FOCU-101540, FOCU-101541, FOCU-101542, FOCU-101543, FOCU-101544, FOCU-101545, FOCU-101546, FOCU-101547, FOCU-101548, FOCU-101549, FOCU-101550, FOCU-101551, FOCU-101552, FOCU-101553, focu-101554, Focu-101555, focu-101556, FOCU-101557, FOCU-101558, FOCU-101559, FOCU-101560, FOCU-101561, FOCU-101562, FOCU-101563, FOCU-101564, FOCU-101565, FOCU-101566, FOCU-101567, focu-101568, focu-101569, FOCU-101570, FOCU-101571, FOCU-101572, FOCU-101573, FOCU-101574, FOCU-101575, FOCU-101576, FOCU-101577, FOCU-101578, FOCU-101579, FOCU-101580, FOCU-101581, FOCU-101582, FOCU-101583, FOCU-101584, FOCU-101585, FOCU-101586, FOCU-101587, FOCU-101588, FOCU-101589, FOCU-101590, FOCU-101591, FOCU-101592, FOCU-101593, FOCU-101594, FOCU-101595, FOCU-101596, FOCU-101597, FOCU-101598, FOCU-101599, FOCU-101600, FOCU-101601, FOCU-101602, FOCU-101603, FOCU-101604, FOCU-101605, FOCU-101606, FOCU-101607, FOCU-101608, FOCU-101609, FOCU-101610, FOCU-101611, FOCU-101612, FOCU-101613, FOCU-101614, FOCU-101615, FOCU-101616, focu-101617, focu-101618, focu-101619, focu-101620, focu-101621, focu-101622, focu-101623, focu-101624, focu-101625, focu-101626, focu-101627, focu-101628, focu-101629, focu-101630, focu-101631, focu-101632, focu-101633, focu-101634, focu-101635, focu-101636, focu-101637, focu-101638, focu-101639, focu-101640, focu-101641, focu-101642, focu-101643, focu-101644, FOCU-101645, focu-101646, focu-101647, FOCU-101648, focu-101649, focu-101650, focu-101651, FOCU-101652, FOCU-101653, FOCU-101654, FOCU-101655, FOCU-101656, FOCU-101657, focu-101658, focu-101659, focu-101660, focu-101661, focu-101662, 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.

Anesthesiology Devices

2

No

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.

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.

serial numbers:  ABSO-004448, ABSO-004458, ABSO-004459, ABSO-004460, ABSO-004461, ABSO-004462, ABSO-004463, ABSO-004465, ABSO-004466, ABSO-004467, ABSO-004468, ABSO-004469, ABSO-004470, ABSO-004471, ABSO-004472, ABSO-004473, ABSO-004474, ABSO-004475, ABSO-004476, ABSO-004477, ABSO-004478, ABSO-004479, ABSO-004480, ABSO-004481, ABSO-004482, ABSO-004483, ABSO-004487, ABSO-004488, ABSO-004489, ABSO-004490, ABSO-004491, ABSO-004492, ABSO-004493, ABSO-004494, ABSO-004495, ABSO-004497, ABSO-004499, ABSO-004500, ABSO-004503, ABSO-004504, ABSO-004505, ABSO-004506, ABSO-004507, ABSO-004508, ABSO-004510, ABSO-004511, ABSO-004512, ABSO-004513, ABSO-004526, ABSO-004528, ABSO-004529, ABSO-004530, ABSO-004531, ABSO-004532, ABSO-004533, ABSO-004534, ABSO-004535, ABSO-004536, ABSO-004537, ABSO-004538, ABSO-004539, ABSO-004540, ABSO-004541, ABSO-004542, ABSO-004543, ABSO-004544, ABSO-004545, ABSO-004564, ABSO-004566, ABSO-004567, ABSO-004568, ABSO-004569, ABSO-005883, ABSO-005884, ABSO-005885, ABSO-005886, ABSO-005887, ABSO-005945, ABSO-005947, ABSO-005948, ABSO-005949, ABSO-005950, ABSO-100023, ABSO-100024, ABSO-100038, ABSO-100039, ABSO-100040, ABSO-100041, ABSO-100042, ABSO-100043, ABSO-100070, ABSO-100071, ABSO-100072, ABSO-100073, ABSO-100074, ABSO-100075, ABSO-100076, ABSO-100077, ABSO-100078, ABSO-100079, ABSO-100080, ABSO-100081, ABSO-100082, ABSO-100083, ABSO-100084, ABSO-100085, ABSO-100086, and ABSO-100087.   Firm added ABSO 004581 - which was inSpacelaabs inventory, in transit to a Field Service Engineer, at the time the recall was initiated. the nonconforming absorber has been replaced with a conforming part and this absober serial number was added to the US Spacelabs Recall tracking.  Five incorrect serialnumbers were included in the original serial numbers provided to FDA. This was a result of a data entry error. An updated US and Rest of the World customer/Serial number was provided to FDA 3/25/2013. The correction to the Rest of the World report is as follows: Incorrect SN Reported to FDA Correct, Nonconforming SN ABSO 005883 ABSO-004514 ABSO 005884 ABSO-004515 ABSO 005885 ABSO-004516 ABSO 005886 ABSO-004517 ABSO 005887 ABSO-004518

Anesthesiology Devices

2

No

Worldwide Distribution - USA Nationwide including the states of New Mexico, North Carolina and the countries of Argentina, China, Mexico, and Taiwan.

Spacelabs BleaseSirius Anesthesia Workstation, BleaseFocus Anesthesia Workstation, and CAS I/II Absorber contained in Service Kits Part Number 12200902, 050-0659-00 and 050-0901-00 and any workstation installed with the CAS I/II Absorber. || Anesthesia workstation for use in the hospital environment and locations not requiring portability.

ARKN-000001, ARKN-000005, ARKN-000010, ARKN-000015, ARKN-000016, ARKN-000017, ARKN-000018, ARKN-000020, ARKN-000021.

Anesthesiology Devices

2

No

Worldwide Distribution - USA including South Carolina and internationally to Canada and Great Britian.

Spacelabs ARKON Anesthesia Workstation. || Spacelabs ARKON Anesthesia Workstation may be used for the delivery of oxygen, air and nitrous oxide in a controlled manner to various patient breathing circuits with or without the use of mechanical ventilator, and may be used for the delivery of anesthetic vapor by use of a dismountable vaporizer.

SERIAL NUMBERS OF UNITS DISTRIBUTED IN THE US:  ARKN-000011, ARKN-000016, ARKN-000017, ARKN-000019, ARKN-000020, ARKN-000021, ARKN-000022, ARKN-000023, ARKN-000024, ARKN-000025, ARKN-000026, ARKN-000027, ARKN-000028, ARKN-000029, ARKN-000030, and ARKN-000031.

Anesthesiology Devices

2

No

USA Nationwide Distribution in the states of North Carolina and South Carolina

SpaceLabs Arkon Anesthesia Delivery System with Version 2.0 Software installed. This system includes a ventilator.