Natus Medical Incorporated

*************Serial Numbers of Units distributed in the US **************  004329, 004330, 004349, 004360, 004361, 004362, 004363, 004364, 004365, 004366, 004367, 004369, 004370, 004371, 004417, 004421, 004426, 004436, 004437, 004443, 004448, 004449, 004454, 004456, 004473, 004481, 004488, 004490, 004494, 004495, 004502, 004507, 004517, 004523, 004525, 004526, 004527, 004528, 004530, 004533, 004539, 004541, 004544, 004545, 004546, 004548, 004552, 004553, 004554, 004555, 004556, 004557, 004558, 004567, 004568, 004573, 004578, 004581, 004582, 004584, 004588, 004591, 004602, 004608, 004630, 004632, 004637, 004640, 004647, 004659, 004667, 004668, 004670, 004672, 004673, 004677, 004678, 004679, 004681, 004683, 004684, 004685, 004686, 004693, 004694, 004696, 004700, 004706, 004707, 004708, 004709, 004710, 004711, 004712, 004713, 004714, 004715, 004716, 004717, 004718, 004719, 004720, 004721, 004722, 004723, 004724, 004725, 004726, 004727, 004728, 004729, 004730, 004731, 004732, 004733, 004734, 004735, 004736, 004737, 004738, 004739, 004740, 004741, 004742, 004743, 004745, 004746, 004747, 004749, 004750, 004753, 004754, 004756, 004757, 004760, 004761, 004762, 004763, 004764, 004766, 004767, 004768, 004771, 004772, 004773, 004774, 004775, 004776, 004777, 004778, 004779, 004780, 004781, 004782, 004783, 004784, 004785, 004787, 004788, 004789, 004790, 004791, 004793, 004794, 004795, 004796, 004797, 004798, 004800, 004801, 004802, 004803, 004804, 004805, 004806, 004807, 004808, 004810, 004811, 004812, 004814, 004815, 004816, 004818, 004819, 004820, 004822, 004823, 004824, 004825, 004826, 004827, 004828, 004829, 004830, 004831, 004832, 004833, 004834, 004835, 004836, 004837, 004838, 004839, 004840, 004841, 004842, 004843, 004844, 004845, 004846, 004847, 004848, 004849, 004850, 004851, 004852, 004853, 004854, 004855, 004856, 004857, 004858, 004859, 004860, 004861, 004862, 004863, 004864, 004865, 004866, 004867, 004868, 004869, 004870, 004871, 004872, 004873, 004874, 004876, 004877, 004878, 004879, 004880, 004881, 004882, 004884, 004885, 004886, 004887, 004888, 004890, 004891, 004893, 004894, 004895, 004896, 004897, 004899, 004900, 004901, 004902, 004903, 004904, 004905, 004906, 004907, 004909, 004910, 004997, 004998, 004999, 005007, 005008, 005009, 005010, 005011, 005012, 005013, 005014, 005015, 005016, 005017, 005018, 005019, 005020, 005021, 005022, 005023, 005024, 005025, 005026, 005027, 005028, 005029, 005030, 005031, 005032, 005033, 005034, 005035, 005036, 005037, 005039, 005040, 005041, 005042, 005043, 005044, 005045, 005046, 005047, 005048, 005049, 005050, 005051, 005052, 005053, 005054, 005055, 005056, 005057, 005058, 005059, 005060, 005061, 005062, 005063, 005064, 005065, 005066, 005067, 005068, 005069, 005070, 005071, 005072, 005073, 005074, 005075, 005076, 005077, 005078, 005079, 005080, 005081, 005082, 005083, 005084, 005085, 005086, 005087, 005088, 005089, 005090, 005091, 005092, 005093, 005094, 005095, 005096, 005097, 005098, 005099, 005100, 005101, 005103, 005104, 005105, 005106, 005107, 005108, 005112, 005113, 005115, 005117, 005118, 005119, 005120, 005121, 005122, 005123, 005124, 005125, 005128, 005136, 005137, 005138, 005139, 005140, 005141, 005142, 005143, 005144, 005145, 005146, 005147, 005148, 005149, 005150, 005151, 005152, and 005153.   *************Serial Numbers of Units distributed in the US **************    004283, 004284, 004285, 004286, 004287, 004288, 004290, 004291, 004292, 004293, 004294, 004295, 004296, 004298, 004299, 004302, 004303, 004305, 004306, 004307, 004308, 004309, 004310, 004312, 004313, 004314, 004315, 004316, 004319, 004320, 004321, 004322, 004325, 004326, 004327, 004328, 004332, 004333, 004334, 004335, 004337, 004338, 004339, 004340, 004341, 004343, 004344, 004345, 004347, 004348, 004350, 004351, 004353, 004354, 004355, 004356, 004357, 004359, 004372, 004373, 004374, 004375, 004379, 004380, 004381, 004382, 004383, 004384, 004385, 004386, 004388, 004389, 004390, 004391, 004392, 004393, 004394, 004395, 004396, 004397, 004399, 004400, 004401, 004402, 004403, 004404, 004405, 004406, 004408, 004411, 004412, 004413, 004414, 004415, 004416, 004418, 004419, 004420, 004422, 004423, 004424, 004425, 004427, 004428, 004430, 004431, 004432, 004433, 004439, 004440, 004442, 004445, 004446, 004447, 004450, 004451, 004452, 004453, 004455, 004457, 004458, 004459, 004460, 004462, 004463, 004464, 004465, 004466, 004467, 004468, 004469, 004471, 004472, 004474, 004475, 004476, 004477, 004478, 004479, 004480, 004484, 004485, 004486, 004489, 004491, 004492, 004496, 004497, 004498, 004499, 004500, 004501, 004503, 004504, 004505, 004508, 004510, 004511, 004512, 004513, 004514, 004515, 004516, 004518, 004519, 004520, 004521, 004522, 004524, 004531, 004532, 004536, 004542, 004543, 004549, 004551, 004565, 004569, 004570, 004571, 004572, 004574, 004575, 004576, 004577, 004585, 004587, 004589, 004590, 004592, 004593, 004594, 004596, 004597, 004598, 004599, 004600, 004601, 004604, 004605, 004606, 004609, 004610, 004611, 004612, 004613, 004614, 004615, 004616, 004617, 004618, 004619, 004620, 004621, 004622, 004623, 004624, 004625, 004626, 004628, 004629, 004631, 004633, 004634, 004635, 004638, 004639, 004641, 004642, 004643, 004644, 004645, 004646, 004648, 004649, 004650, 004651, 004652, 004653, 004655, 004656, 004657, 004658, 004660, 004662, 004663, 004664, 004665, 004666, 004669, 004671, 004674, 004675, 004680, 004682, 004688, 004689, 004690, 004692, 004695, 004697, 004698, 004699, 004701, 004702, 004703, 004704, 004705, 004744, 004748, 004751, 004752, 004755, 004758, 004765, 004769, 004770, 004792, 004799, 004809, 004813, 004817, 004821, 004875, 004889, 004898, 004908, 005102, 005111, 005114, 005116, 005126, 005127, 005129, 005130, 005131, 005132, 005133, 005134, 005135, 005154, 005155, 005239, 005240, 005241, 4317, 4323, 4324, 4368, and 4377.

General Hospital and Personal Use Devices

2

No

Worldwide Distribution - USA (nationwide) Distribution to the states of : AL, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MS, NC, ND, NJ, NM, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WI, WV and Puerto Rico. , and to the countries of : Argentina, Austria, Canada, Chile, China, Denmark, Dominican Republic, Finland, France, Germany, Hong Kong, Hungary, Indonesia, Italy, Latvia, Malaysia, Namibia, Paraguay, Poland, Qatar, Romania, Russia, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Taiwan, Trinidad and Tobago, Turkey, United Arab Emirates, United Kingdom, Uruguay, Viet Nam, and Virgin Islands (British).

Updated Natus neoBLUE blanket LED Phototherapy Systems. It provides phototherapy underneath the infant and can be used in a bassinet, open bed, radiant warmer, incubator, or while holding the infant. || Affected systems including: || 1) Updated light boxes (serial number xxxx004283 or greater) have protection built in to turn off the device if an overheat condition is detected. || 2) Updated fiberoptic blankets (Lot Nxxxx16-xx or greater) have an improved fiberoptic cable end to reduce the degradation and increase its useful life. || Affected Part Numbers and Description: || 006244 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad || 006254 neoBLUE blanket LED Light Box || 006895 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad || 007299 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad EUR || 007300 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad EUR || 007296 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad UK || 007298 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad UK || 007301 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad AUS || 007302 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad AUS

************SERIAL NUMBERS OF UNITS DISTRIBUTED TO US GOVERMENT ACCOUNTS  000089, 000104, 000128, 001342, 001364, 001367, 001371, 001372, 001373, 001374, 001375, 001376, 001377, 001391, 001392, 001393, 001394, 001441, 001442, 001455, 001456, 001463, 001495, 001496, 001497, 001878, 001893, 001912, 001915, 001992, 001993, 002040, 002041, 002165, 002166, 002167, 002168, 002289, 002290, 002291, 002292, 002320, 002462, 002463, 002762, 002763, 002766, 002860, 002870, 002873, 002888, 003594, 003595, 003600, 003604, 003632, 003633, and 003893.  ***********SERIAL NUMBERS OF UNITS DISTRIBUTED IN THE US  ..000284, ..000287, ..000297, ..000299, ..000310, ..000324, ..000328, ..000365, .000301, .000313, .000321, .000322, .000323, .000352, .000415, .000419, .000420, .000426, .000427, .000435, .000445, .000449, .000467, .000483, .000508, .000518, .000523, .000531, .000541, .000581, .000651, .000670, .000695, .000696, .000697, .000698, 000030, 000031, 000032, 000033, 000035, 000036, 000039, 000041, 000042, 000043, 000044, 000046, 000048, 000050, 000051, 000052, 000053, 000056, 000062, 000070, 000076, 000081, 000082, 000085, 000086, 000087, 000088, 000093, 000094, 000139, 000140, 000143, 000144, 000146, 000162, 000163, 000164, 000166, 000167, 000170, 000180, 000181, 000187, 000189, 000190, 000193, 000195, 000202, 000205, 000208, 000215, 000218, 000221, 000223, 000234, 000235, 000238, 000240, 000242, 000243, 000244, 000245, 000246, 000248, 000249, 000250, 000253, 000254, 000255, 000257, 000263, 000275, 000276, 000281, 000290, 000291, 000292, 000293, 000303, 000317, 000320, 000325, 000332, 000333, 000335, 000336, 000340, 000343, 000344, 000345, 000349, 000350, 000351, 000352, 000353, 000354, 000366, 000411, 000414, 000417, 000418, 000422, 000424, 000425, 000428, 000430, 000432, 000436, 000441, 000442, 000443, 000446, 000452, 000453, 000454, 000456, 000457, 000458, 000459, 000460, 000462, 000469, 000472, 000475, 000477, 000479, 000483, 000489, 000493, 000495, 000499, 000500, 000502, 000511, 000516, 000522, 000528, 000530, 000547, 000551, 000553, 000560, 000561, 000563, 000565, 000570, 000574, 000599, 000604, 000615, 000616, 000619, 000620, 000625, 000628, 000631, 000641, 000643, 000646, 000647, 000648, 000655, 000656, 000662, 000664, 000667, 000671, 000675, 000680, 000681, 000682, 000683, 000684, 000687, 000693, 000694, 000697, 000708, 000709, 000711, 000712, 000715, 000717, 000718, 000719, 000720, 000731, 000732, 000734, 000735, 000736, 000740, 000741, 000743, 000744, 000745, 000749, 000751, 000752, 000754, 000758, 000760, 000762, 000763, 000766, 000767, 000768, 000769, 000770, 000771, 000772, 000774, 000775, 000776, 000781, 000782, 000783, 000784, 000785, 000786, 000787, 000788, 000789, 000790, 000792, 000793, 000794, 000796, 000797, 000798, 000799, 000800, 000801, 000802, 000803, 000804, 000805, 000806, 000807, 000808, 000809, 000810, 000812, 000813, 000814, 000815, 000816, 000817, 000818, 000820, 000821, 000822, 000825, 000826, 000831, 000833, 000836, 000847, 000848, 000849, 000850, 000851, 000852, 000854, 000857, 000858, 000859, 000861, 000862, 000863, 000865, 000866, 000867, 000868, 000869, 000870, 000871, 000873, 000874, 000875, 000876, 000877, 000878, 000879, 000880, 000882, 000884, 000891, 000892, 000893, 000899, 000900, 000901, 000902, 000903, 000904, 000905, 000907, 000908, 000909, 000910, 000912, 000913, 000914, 000915, 000916, 000921, 000922, 000923, 000924, 000925, 000935, 000936, 000937, 000938, 000939, 000940, 000941, 000943, 000944, 000945, 000946, 000947, 000950, 000952, 000953, 000957, 000958, 000959, 000960, 000961, 000962, 000963, 000965, 000966, 000967, 000970, 000972, 000973, 000974, 000976, 000978, 000979, 000981, 000988, 000991, 000992, 000993, 001005, 001006, 001010, 001011, 001012, 001013, 001018, 001019, 001020, 001021, 001022, 001031, 001035, 001036, 001037, 001038, 001039, 001040, 001041, 001042, 001043, 001044, 001046, 001047, 001048, 001050, 001056, 001058, 001059, 001085, 001086, 001087, 001088, 001095, 001103, 001104, 001105, 001106, 001109, 001110, 001111, 001113, 001115, 001117, 001118, 001119, 001121, 001122, 001123, 001124, 001125, 001126, 001127, 001128, 001129, 001130, 001131, 001133, 001134, 001135, 001136, 001137, 001138, 001139, 001140, 001141, 001143, 001144, 001146, 001149, 001150, 001153, 001154, 001155, 001156, 001161, 001162, 001163, 001164, 001165, 001166, 001167, 001190, 001205, 001206, 001207, 001208, 001209, 001211, 001213, 001214, 001215, 001216, 001217, 001218, 001219, 001220, 001221, 001222, 001223, 001224, 001225, 001227, 001228, 001230, 001231, 001233, 001235, 001236, 001239, 001241, 001242, 001249, 001252, 001253, 001254, 001255, 001256, 001257, 001260, 001261, 001262, 001265, 001266, 001268, 001269, 001271, 001272, 001274, 001275, 001277, 001280, 001281, 001283, 001288, 001289, 001290, 001291, 001292, 001293, 001294, 001296, 001297, 001299, 001300, 001301, 001302, 001305, 001307, 001309, 001311, 001312, 001315, 001316, 001319, 001321, 001327, 001329, 001330, 001331, 001334, 001335, 001338, 001340, 001346, 001348, 001349, 001350, 001351, 001353, 001354, 001356, 001357, 001360, 001361, 001362, 001363, 001366, 001368, 001370, 001378, 001379, 001380, 001381, 001382, 001383, 001384, 001385, 001386, 001387, 001388, 001389, 001390, 001397, 001398, 001399, 001400, 001401, 001402, 001403, 001404, 001406, 001407, 001408, 001409, 001411, 001414, 001415, 001416, 001419, 001420, 001425, 001427, 001428, 001429, 001430, 001431, 001432, 001433, 001434, 001435, 001436, 001437, 001439, 001440, 001443, 001444, 001445, 001446, 001447, 001452, 001454, 001457, 001467, 001470, 001472, 001473, 001474, 001475, 001476, 001477, 001478, 001481, 001486, 001492, 001494, 001499, 001500, 001503, 001507, 001528, 001532, 001540, 001541, 001542, 001543, 001544, 001545, 001546, 001547, 001548, 001549, 001550, 001551, 001552, 001553, 001554, 001556, 001557, 001558, 001559, 001560, 001562, 001564, 001565, 001566, 001567, 001568, 001569, 001579, 001580, 001581, 001582, 001583, 001584, 001586, 001587, 001588, 001589, 001590, 001591, 001592, 001593, 001594, 001596, 001597, 001598, 001599, 001600, 001601, 001602, 001603, 001607, 001613, 001614, 001615, 001616, 001617, 001618, 001619, 001620, 001622, 001623, 001624, 001625, 001626, 001627, 001629, 001630, 001631, 001632, 001633, 001634, 001636, 001637, 001638, 001640, 001644, 001645, 001646, 001647, 001648, 001649, 001650, 001651, 001652, 001656, 001657, 001658, 001661, 001662, 001663, 001665, 001666, 001667, 001680, 001681, 001682, 001683, 001685, 001686, 001687, 001689, 001691, 001693, 001695, 001696, 001698, 001701, 001702, 001703, 001709, 001711, 001712, 001714, 001715, 001716, 001717, 001718, 001719, 001720, 001721, 001729, 001733, 001738, 001740, 001741, 001742, 001748, 001752, 001753, 001755, 001757, 001758, 001760, 001761, 001762, 001764, 001765, 001766, 001769, 001771, 001772, 001774, 001777, 001779, 001780, 001781, 001785, 001799, 001813, 001814, 001815, 001817, 001818, 001821, 001822, 001823, 001834, 001836, 001840, 001844, 001845, 001846, 001848, 001850, 001851, 001852, 001855, 001856, 001858, 001860, 001861, 001862, 001863, 001864, 001866, 001867, 001868, 001869, 001872, 001873, 001874, 001875, 001876, 001879, 001880, 001881, 001882, 001883, 001890, 001894, 001895, 001896, 001897, 001898, 001899, 001900, 001902, 001903, 001904, 001905, 001906, 001907, 001908, 001909, 001910, 001916, 001917, 001918, 001919, 001920, 001921, 001922, 001923, 001924, 001925, 001926, 001927, 001928, 001929, 001930, 001932, 001935, 001936, 001937, 001938, 001939, 001940, 001941, 001942, 001943, 001946, 001947, 001948, 001949, 001950, 001951, 001953, 001954, 001955, 001956, 001957, 001958, 001959, 001960, 001961, 001962, 001963, 001964, 001965, 001967, 001969, 001970, 001973, 001974, 001979, 001982, 001983, 001984, 001987, 001988, 001990, 001991, 001994, 002001, 002009, 002010, 002014, 002016, 002017, 002018, 002019, 002020, 002021, 002022, 002023, 002024, 002026, 002027, 002031, 002032, 002034, 002037, 002038, 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R002390, and R002414.

General Hospital and Personal Use Devices

2

No

Worldwide Distribution - USA (nationwide) Distribution and to the countries of : including American Samoa and Guam, and in the following countries: Albania, Argentina, Australia, Austria, Bangladesh, Canada, Chile, Costa Rica, Croatia, Czech Republic, Denmark, Ecuador, Finland, France, Germany, Hong Kong, Indonesia, Iraq, Israel, Italy, Korea, Kuwait, Latvia, Malaysia, Mongolia, Namibia, Netherlands, Nigeria, Norway, Panama, Peru, Philippines, Poland, Portugal, Romania, Russia, Saudi Arabia, Singapore, Slovakia (Slovak Republic), Slovenia, South Africa, Spain, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Uruguay, Viet Nam, and Virgin Islands (British).

Natus neoBLUE blanket LED Phototherapy system, neonatal phototherapy. Used to provide treatment for neonatal Hyperbilirubinemia. || 006224 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad || 006254 neoBLUE blanket LED Light Box || 006895 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad || 007299 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad EUR || 007300 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad EUR || 007296 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad UK || 007298 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad UK || 007301 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad AUS || 007296 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad AUS

Catalogue / Part Numbers: 010101 (110V, US, new); 010101R (110V, US, refurbish); 010102 (230V, UK, new); 010102R (230V, UK, refurbish); 010103 (230V, EUR, new); 010103R (230V, EUR, refurbish); 010104 (230V, EUR, new); 010104R (230V, EUR, refurbish).  AFFECTED SERIAL NUMBERS:  60011-60013, 60015, 60017, 60021-60029, 60031-60033, 60035, 60037, 60038, 60101-60120, 60124-60128, 60131-60324, 60327-60349, 60351-60403, 60405, 60407-60415, 60417-60507, 60509-60586, 60588-60606, 60608-60611, 60613-60845, 60847-61000, 61002-61293, 61295-61340, 61346-61574, 61577-61590, 62001-62026, 62028-62032, 62035-62145, 62147-62163, 62165-62245, 62247-62252, 62254-62309, 62311-62350, 62352-62433, 62435-62481, 62485-62634, 62636-62640, and 62642-62656.

General Hospital and Personal Use Devices

2

No

Worldwide distribution: USA, Argentina, Australia, Austria, Belgium, Bermuda, Canada, Chile, Denmark, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Iraq, Israel, Italy, Japan, Kenya, Kuwait, Lithuania, Malaysia, Mexico, Morocco, Netherlands, Norway, Philippines, Poland, Portugal, PR, Qatar, Russia, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, UAE, and UK

The Natus Blue Light Phototherapy is also called the "neoBLUE LED Phototherapy System". The "neoBLUE mini LED Phototherapy System"

Cooling Serial Numbers: 1008; 1009; 1011; 1012; 1014; 1016; 1017; 1018; 1020; 1021; 1022; 1023; 1024; 1025; 1027; 1028; 1030; 1031; 1034; 1035; 1036; 1038; 1044; 1045; 1048; 1050; 1051; 1052; 1053; 1054; 1055; 1056; 1059; 1060; 1062; 1063; 1064; 1065; 1066; 1070; 1071; 1072; 1073; 1074; 1075; 1076; 1077; 1080; 1081; 1082; 1083; 1085; 1086; 1087; 1088; 1090; 1091; 1092; 1093; 1094; 1095; 1096; 1097; 1101; 1116; 1117; 1118; 1119; 1120; 1122; 1124; 1125; 1126; 1127; 1128; 1129; 1130; 1131; 1132; 1136; 1137; 1138; 1139; 1141; 7002; 7003; 7004; 7005; 7007; 7008; 7009; 7010; 7011; 7013; 7014; 7016; 7017; 7018; 7019; 7020; 7021; 7022; 7023; 7024; 7025; 7026; 7027; 7028; 7030; 7031; 7032; 7033; 7034; 7036; 7037; 7038; 7039; 7040; 7041; 7042; 7043; 7044; 7045; 7046; 7047; 7048; 7049; 7051; 7052; 7053; 7054; 7055; 7250; 7251; 7252; 7253; 7255; 7256; 7257; 7258; 7259; 7260; 7261; 7262; 7263; 7264; 7265; 7266; 7267; 7268; 7269; 7270; 7271; 7272; 7273; 7274; 7275; 7276; 7277; 7278; 7279; 7280; 7281; 7282; 7283; 7284; 7285; 7286; 7288; 7289; 7290; 7291; 7292; 7293; 7294; 7363; 7364; 7365; 7366; 7372; and 7374.

Neurological Devices

3

No

Worldwide Distribution -- USA (nationwide) including the states of : AK; AR; AZ; CA; CO; DE; FL; GA; HI; ID; IL; IN; KY; MA; MI; MN; MS; ND; NE; NJ; NY; OH; PA; SC; SD; TN; TX; and WA. and the countries of : Argentina; Australia; Austria; Canada; Egypt; Germany; Hong Kong; Indonesia; Iran; Italy; Kuwait; Poland; Russia; Saudi Arabia; Singapore; Slovenia; South Africa; South Korea; Spain; Taiwan; Thailand; Turkey; United Arab Emirates; and United Kingdom.

Olympic Cool-Cap System is intended to provide treatment for || neonatal hypoxic-ischemic encephalopathy (HIE). || The Cool-Cap is indicated for use in full term infants (more than 36 week gestational age) with clinical evidence of moderate to severe HIE. The device provides selective head cooling with mild systemic hypothermia to prevent or reduce the severity of neurologic injury associated with HIE. || It is a selective head cooling system for treatment of neonatal hypoxic-ischemic encephalopathy (HIE) in infants. A cooling water cap is placed on the infant's head and the body is warmed using radiant warmers. The Cool-Cap provides 72 hours of monitored cooling. || The device is labeled in part: "***OLYMPIC COOL-CAP Cooling Unit***Model No.***Made in USA***Software in this product is Natus Medical Incorporated***"

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Neurological Devices

3

No

Worldwide distribution: USA (nationwide) including states of: AK, AR, AZ, CA, CO, DE, FL, GA, HI, ID, IL, IN, KY, MA, MI, MN, MS, ND, NE, NJ, NV, NY, OH, OK, PA, SC, SD, TN, TX, UT, WA, Puerto Rico, and countries of: Argentina, Australia, Austria, Bahrain, Canada, Chile, China, Colombia, Ecuador, Egypt, Germany, Germany, Hong Kong, India, Indonesia, Iran, Iraq, Italy, Kuwait, Latvia, Malaysia, Mexico, Morocco, Panama, Puerto Rico, Poland, Qatar, Romania, Russia, Saudi Arabia, Singapore, Slovenia, South Africa, South Korea, Spain, Taiwan, Thailand, Turkey, Ukraine, United Arab Emirates, United Kingdom, Venezuela, and Vietnam.

The product has the Catalogue/Part number 60010. || Olympic Cool-Cap System is a selective head cooling system for treatment of hypoxic-ischemic encephalopathy (HIE) in infants. A cooling water cap is placed on the infant's head and the body is warmed using radiant warmers. The Cool-Cap provides 72 hours of monitored cooling. || The device is labeled in parts: "***OLYMPIC COOL-CAP Cooling Unit***Natus Medical Incorporated 5900 First Avenue South ***Made in USA***Control Unit Model No. 60010***Software in this product is***Technical Service***"