Model Catalog: (Lot serial: )

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Model Catalog: NATAL CARE ST-LX (Lot serial: 5491); Model Catalog: NATAL CARE ST-LX (Lot serial: 5490)

NATALCARE ST-LX

Model Catalog: NATAL CARE ST-LX (Lot serial: 5009); Model Catalog: NATAL CARE ST-LX (Lot serial: 5490); Model Catalog: NATAL CARE ST-LX (Lot serial: 5491)

NATALCARE ST-LX

Physical therapy - climatotherapy

SERIAL NUMBERS:  0.23998, 1, 13201, 18002, 18003, 18004, 18005, 18006, 18007, 18008, 18009, 18010, 18011, 18012, 18013, 18015, 18016, 18017, 18018, 18019, 18020, 18021, 18022, 18023, 18040, 18041, 18042, 18043, 18044, 18045, 18046, 18047, 18048, 18049, 18050, 18051, 18052, 18053, 18054, 18055, 18056, 18057, 18058, 18059, 18060, 18061, 18062, 18063, 18064, 18065, 18066, 18067, 18068, 18069, 18070, 18071, 18072, 18073, 18074, 18075, 18076, 18077, 18078, 18086, 18087, 18088, 18089, 18090, 18091, 18092, 18118, 18119, 18120, 18121, 18122, 18133, 18134, 18302, 18303, 18304, 18305, 18306, 18307, 18308, 18309, 18310, 18311, 18312, 18313, 18314, 18315, 18316, 18317, 18318, 18319, 18320, 18328, 18329, 18330, 18331, 18332, 18333, 18334, 18335, 18336, 18337, 18338, 18339, 18340, 18341, 18342, 18343, 18344, 18345, 18346, 18347, 18348, 18349, 18350, 18351, 18352, 18353, 18355, 18356, 18357, 18358, 18359, 18360, 18361, 18362, 18363, 18364, 18365, 18366, 18367, 18368, 18369, 18370, 18371, 18372, 18373, 18374, 18375, 18376, 18377, 18378, 18379, 18380, 18381, 18382, 18383, 18384, 18385, 18386, 18387, 18388, 18389, 18390, 18392, 18405, 18407, 18408, 18409, 18410, 18411, 18413, 18414, 18415, 18416, 18417, 18418, 18419, 18420, 18421, 18422, 18423, 18424, 18425, 18426, 18427, 18428, 18429, 18430, 18431, 18432, 18433, 18434, 18664, 18665, 18666, 18667, 18668, 18669, 18670, 18671, 18672, 18673, 18674, 18675, 18676, 18677, 18678, 18679, 18680, 18681, 18682, 18683, 18684, 18685, 18686, 18687, 18688, 18689, 18690, 18691, 18692, 18693, 18694, 18695, 18696, 18697, 18698, 18699, 18700, 18701, 18702, 18703, 18704, 18705, 18706, 18707, 18708, 18709, 18710, 18711, 18712, 18713, 18714, 18718, 18719, 18720, 18725, 18726, 18728, 18729, 18730, 18731, 18732, 18733, 18734, 18735, 18736, 18737, 18738, 18739, 18740, 18741, 18742, 18743, 18744, 18745, 18746, 18747, 18763, 18764, 18765, 18766, 18767, 18768, 18769, 18770, 18771, 18772, 18773, 18774, 18775, 18776, 18777, 18778, 18779, 18780, 18781, 18782, 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19391.19392, 19393, 19394, 19395, 19396, 19397, 19398, 19399, 19400, 19401, 19402, 19403, 19404, 19405, 19406, 19409, 19410, 19411, 19412, 19413, 19414, 19415, 19416, 19417, 19418, 19419, 19420, 19421, 19422, 19423, 20637, 20638, 20641, 20642, 20643, 20644, 20645, 20646, 20647, 20648, 20649, 20650, 20651, 20652, 20653, 20654, 20655, 20656, 20657, 20658, 20659, 20660, 20661, 20662, 20663, 20664, 20665, 20666, 20667, 20668, 20669, 20670, 20671, 20672, 20673, 20674, 20675, 20676, 20677, 20710, 20711, 20712, 20713, 20714, 20715, 20716, 20717, 20718, 20719, 20720, 20721, 20722, 20723, 20724, 20725, 20726, 20727, 20728, 20729, 20746, 20747, 20749, 20750, 20751, 20752, 20761, 20762, 20763, 20764, 20765, 20766, 20767, 20768, 20769, 20770, 20771, 20772, 20773, 20774, 20775, 20776, 20777, 20778, 20779, 20780, 20781, 20782, 20783, 20784, 20785, 20786, 20787, 20790, 20791, 20792, 20793, 20794, 20795, 20796, 20797, 20798, 20799, 20800, 20801, 20802, 20803, 20804, 20805, 20806, 20807, 20808, 20809, 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21804, 21805, 21806, 21807, 21808, 21809, 21810, 21811, 21812, 21813, 21814, 21815, 21816, 21817, 21818, 21819, 21820, 21821, 21822, 21823, 21824, 21825, 21826, 21827, 21828, 21829, 21830, 21831, 21832, 21833, 21834, 21835, 21836, 21837, 21838, 21839, 21840, 21841, 21842, 21843, 21844, 21845, 21846, 21847, 21848, 21849, 21850, 21851, 21852, 21868, 21870, 21871, 21872, 21873, 21874, 21875, 21876, 21877, 21878, 21879, 21880, 21881, 21882, 21883, 21884, 21885, 21886, 21887, 21888, 21889, 21890, 21892, 21893, 21894, 21895, 21896, 21897, 21898, 21899, 21900, 21901, 21902, 21903, 21904, 21905, 21906, 21907, 21908, 21909, 21910, 21911, 21912, 21913, 21914, 21915, 21951, 21952, 21953, 21954, 21955, 21956, 21957, 21958, 21959, 21971, 21972, 21973, 21974, 21975, 21976, 21977, 21978, 21979, 21980, 21987, 21989, 21990, 21991, 21992, 21993, 21994, 21995, 21996, 21997, 21998, 21999, 22000, 22001, 22002, 22003, 22004, 22005, 22006, 22007, 22008, 22009, 22010, 22011, 22012, 22013, 22029, 22030, 22031, 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General Hospital and Personal Use Devices

2

No

Nationwide Distribution.

Natus neoBLUE 3 Phototherapy system or Neonatal Phototherapy, Catalogue Part Number: 010066; Top Assembly Part Number: 001103

************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, 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004238, 004240, 004241, 004246, 004247, 004248, 004249, 004250, 004251, 004252, 004253, 004254, 004255, 004256, 004257, 004258, 004259, 004260, 004261, 004263, 004264, 004268, 004269, 004270, 004271, 004273, 1215R002299, 2298, 2300, 2302, 2303, 2304, NR002392, R002300, R002301, R002357, R002359, R002360, R002362, R002364, R002365, R002368, R002369, R002370, R002389, R002413, R002415, R002416, and R002417.    ************SERIAL NUMBERS OF UNITS DISTRIBUTED OUTSIDE US   ..000283, 000061, 000064, 000066, 000067, 000069, 000078, 000079, 000121, 000123, 000125, 000129, 000130, 000131, 000136, 000137, 000147, 000148, 000149, 000150, 000152, 000153, 000155, 000168, 000169, 000173, 000174, 000182, 000183, 000192, 000194, 000196, 000198, 000200, 000201, 000211, 000212, 000216, 000219, 000227, 000280, 000295, 000296, 000298, 000300, 000302, 000306, 000309, 000315, 000326, 000334, 000356, 000357, 000368, 000369, 000412, 000423, 000429, 000437, 000451, 000471, 000515, 000521, 000536, 000537, 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001083, 001084, 001089, 001090, 001091, 001092, 001093, 001097, 001098, 001099, 001100, 001101, 001102, 001114, 001172, 001178, 001179, 001187, 001188, 001192, 001193, 001194, 001198, 001244, 001245, 001246, 001247, 001248, 001250, 001251, 001320, 001325, 001326, 001328, 001332, 001333, 001336, 001339, 001341, 001343, 001345, 001352, 001355, 001358, 001359, 001365, 001395, 001396, 001417, 001418, 001423, 001450, 001451, 001453, 001458, 001459, 001461, 001462, 001479, 001490, 001491, 001509, 001511, 001512, 001513, 001514, 001515, 001516, 001519, 001520, 001521, 001524, 001526, 001561, 001570, 001571, 001572, 001573, 001574, 001576, 001577, 001578, 001604, 001605, 001606, 001608, 001642, 001643, 001659, 001660, 001668, 001669, 001671, 001672, 001673, 001674, 001675, 001676, 001677, 001678, 001694, 001726, 001727, 001728, 001730, 001731, 001732, 001734, 001735, 001736, 001743, 001744, 001745, 001746, 001749, 001750, 001751, 001763, 001773, 001789, 001793, 001796, 001798, 001801, 001802, 001804, 001843, 001859, 001884, 001885, 001888, 001889, 001891, 001892, 001933, 001934, 001968, 001976, 001977, 001985, 001995, 001996, 001997, 001998, 001999, 002000, 002002, 002003, 002004, 002005, 002007, 002011, 002012, 002013, 002025, 002028, 002036, 002039, 002051, 002052, 002053, 002054, 002055, 002056, 002057, 002058, 002059, 002061, 002062, 002065, 002066, 002067, 002068, 002069, 002070, 002071, 002072, 002073, 002074, 002081, 002082, 002083, 002084, 002085, 002187, 002188, 002191, 002192, 002193, 002194, 002195, 002197, 002204, 002205, 002206, 002207, 002210, 002211, 002213, 002214, 002216, 002220, 002221, 002222, 002223, 002224, 002229, 002230, 002231, 002232, 002244, 002245, 002255, 002256, 002257, 002282, 002307, 002318, 002342, 002347, 002350, 002351, 002353, 002354, 002364, 002371, 002372, 002373, 002374, 002375, 002376, 002382, 002383, 002384, 002385, 002391, 002394, 002401, 002402, 002404, 002405, 002406, 002407, 002408, 002409, 002410, 002411, 002412, 002413, 002414, 002423, 002424, 002425, 002426, 002428, 002450, 002464, 002465, 002467, 002477, 002479, 002510, 002511, 002531, 002532, 002534, 002535, 002664, 002665, 002666, 002667, 002668, 002677, 002679, 002681, 002682, 002683, 002684, 002687, 002688, 002689, 002691, 002692, 002693, 002706, 002708, 002709, 002710, 002712, 002713, 002714, 002720, 002730, 002731, 002734, 002737, 002740, 002741, 002742, 002743, 002744, 002745, 002746, 002747, 002748, 002749, 002750, 002756, 002759, 002760, 002761, 002764, 002772, 002797, 002804, 002805, 002806, 002809, 002826, 002834, 002835, 002864, 002865, 002881, 002882, 002916, 002920, 002923, 002927, 002928, 002929, 002930, 002932, 002933, 002935, 002936, 002937, 002938, 002939, 002940, 002941, 002942, 002943, 002944, 002945, 002948, 002949, 002950, 002954, 002955, 002956, 002957, 002996, 002997, 002999, 003000, 003001, 003002, 003003, 003005, 003011, 003012, 003017, 003038, 003051, 003052, 003055, 003056, 003057, 003058, 003059, 003060, 003061, 003062, 003063, 003065, 003066, 003067, 003073, 003081, 003084, 003085, 003086, 003087, 003088, 003089, 003090, 003091, 003092, 003093, 003094, 003096, 003097, 003098, 003099, 003100, 003101, 003130, 003131, 003132, 003133, 003134, 003144, 003145, 003146, 003148, 003157, 003158, 003159, 003162, 003585, 003586, 003587, 003588, 003591, 003598, 003599, 003636, 003637, 003644, 003652, 003653, 003654, 003655, 003656, 003676, 003678, 003704, 003705, 003706, 003707, 003725, 003726, 003727, 003734, 003735, 003738, 003741, 003742, 003770, 003771, 003776, 003777, 003778, 003779, 003781, 003782, 003790, 003807, 003808, 003818, 003819, 003820, 003835, 003842, 003843, 003844, 003848, 003849, 003850, 003851, 003852, 003854, 003864, 003865, 003867, 003876, 003880, 003881, 003884, 003886, 003887, 003888, 003890, 003895, 003897, 003902, 003903, 003905, 003906, 003907, 003909, 003917, 003923, 003925, 003931, 003960, 003969, 003993, 004242, 004243, 004267, 004272, 1517, 1911000001, NR002393, R002358, R002366, R002371, 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

*************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

Natus neoBLUE Blanket LED Phototherapy System - fiberoptic pads, Natus Medical Incorporated

General Hospital and Personal Use Devices

2

No

Worldwide Distributed - US Nationwide in the US including American Samoa, Guam Puerto Rico and in the following countries: Argentina, Australia, Austria, Bangladesh, Belgium, Bermuda, Bolivia, Brunei Darussalam, Canada, China, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Finland, France, Germany, Greece, Guatemala, Hong Kong, Hungary, India, Indonesia, Iraq, Ireland, Israel, Italy, Japan, Jordan, , Kenya, , Kuwait, Latvia, Lithuania, Malaysia, Moldova Republic of, Morocco, Namibia, Netherlands, Norway, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia (Slovak Republic), Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Uruguay, Viet Nam, Virgin Islands (British), and Yemen.

Natus neoBLUE Phototherapy system, Catalogue Part Number: 010066. || Top Assembly Part Numbers: 001103, 001314, 002110, 040906, 040904, 040756, 040758, 040658, 040680. || Product Usage: || Used to provide treatment for neonatal hyperbilirubinemia

Physical therapy

SERIAL NUMBERS: 30317 22029 36079 36063 35182 36070 21963 21964 30068 30240 30170 22083 22085 30285 30286 30288 30323 30192 30214 30207 30325 30106 30168 21971 21972 30075 30212 21760 2717 30293 30365 36002 30193 36121 21962 36124 30364 35089 30045 35101 36090 21677 30362 35244 35209 36091 35297 36089 35032 35304 30167 30290 30110 30111 36012 30382 30410 30411 30412 30419 36107 36113 30407 35245 35293 35312 35181 35254 30315 30318 30384 35178 35173 35144 36186 36178 36199 2730 36125 36123 36132 30380 30428 20945 21249 21398 21580 21892 22120 30149 4268 20661 20704 20646 4140 4035 35190 30314 30328 30313 30327 30348 30401 30400 20322 21278 21272 21273 21678 21898 21747 21750 21823 21983 21741 21662 21989 22185 21821 22018 22017 22027 21826 21656 30124 30128 30130 30122 30032 30267 30268 30084 30022 30257 3637 4012 1956 20742 20737 20878 21581 21586 21587 20876 21110 21111 21156 21275 21281 21282 21283 21401 2363 35162 35163 35168 35170 35151 35024 35183 30349 36167 36168 36170 36171 36067 36111 36181 36183 20909 20952 20998 21634 21522 21614 21655 21673 21713 21718 21719 21720 21723 21724 21977 21978 21979 21980 22077 21981 22050 22051 22049 22052 22074 22076 30078 30079 30080 30082 30083 30102 30133 30134 30135 30208 30210 30209 30121 30132 30188 30187 30190 30189 30191 30220 30221 30223 30222 30304 30279 30057 3926 4099 4100 5248 5264 5288 20178 20746 4223 5152 35233 35102 35290 35120 35154 35225 35226 35227 35229 35230 35231 35232 35155 30330 30390 30391 30311 30347 36054 36056 36068 36119 36037 36069 36118 36108 36109 36106 30395 30406 36155 36164 36165 36196 36152 21471 20875 21863 21864 21862 21855 21928 21929 22209 22010 21919 30225 30227 30228 30211 30028 30141 30142 30027 20410 20794 20860 20870 2561 2856 2857 5369 5387 5094 5095 5273 5274 35052 35076 35077 35096 35100 30346 30358 30359 35305 35316 35309 30429 30123 30150 30259 30278 21540 4055 4320 5479 35200 35201 35115 30388 30393 36041 35318 36047 36100 36101 36103 36127 36131 35126 35234 35280 35285 36046 36099 35259 35287 36049 36102 30392 36145 36190 21668 21680 21900 21984 21661 21867 22067 22068 22024 22098 22128 22129 22173 22184 22055 30119 30269 30273 30271 30275 2705 5137 5142 5309 5311 5380 5411 5451 5135 2954 20807 20820 21373 21394 5370 5418 5108 35106 35160 35267 35093 35185 30310 30350 30351 30378 36021 36042 36074 36143 36142 30272 35263 36110 36188 30439 36117 21173 21705 21704 21751 21866 30151 30118 30234 3932 5224 35060 35103 36018 36053 30404 30430 21479 21875 21876 30036 30064 30063 30152 36078 36036 36016 36153 36179 36180 36200 21162 21268 21228 22103 22044 22045 30072 30113 30144 30238 30295 30296 30019 30029 5308 5429 20673 5301 5122 5419 35167 35110 35153 35069 35237 35248 35236 30354 35288 36154 36038 35314 35255 36104 30396 30432 30379 21745 21830 21908 21907 21943 21944 21942 21945 21947 22175 22236 22237 30180 30179 30181 30177 30215 30127 30250 30251 30255 30258 2648 2707 2935 2712 5315 20955 21092 21142 21333 21328 21330 21331 21443 21445 21509 21563 21577 35157 35215 35216 35217 35223 35224 30301 30283 30335 36051 36052 35310 36135 35317 36031 35274 30413 36112 36115 36141 36146 30247 36160 20902 20922 21348 21392 21388 21389 21551 7487 30366 30367 30368 22021 22061 4169 5105 5106 30136 30137 30139 30140 5367 5530 5529 30387 30386 35306 36203 20982 20984 20985 22181 22177 22195 22196 22197 22199 22198 22211 22212 22222 22220 22227 22229 22241 21858 21860 21903 21906 22125 22123 22130 22133 22135 22138 22140 22141 22146 22148 22149 22176 22189 22188 22192 22231 22242 22092 22131 22218 22248 22244 22249 22252 22253 22255 22254 22256 22259 22261 22262 30185 30186 2006 2242 2205 2086 3990 3998 3999 4000 3750 3882 3881 3884 3888 3889 3901 3902 3909 3936 3944 3975 4272 4274 20799 21632 21622 21595 21596 21608 21602 21085 21180 21242 21244 21245 21300 21309 21316 21308 21310 21317 21315 21319 21424 21425 21395 21396 21459 21470 21484 21485 21499 21525 21523 21532 21557 21559 21560 21561 21542 21502 4288 4291 4295 4297 4299 4300 4307 4308 4309 4310 4313 4314 4318 4322 4325 4334 4335 4336 4338 4339 4198 4201 4194 4206 4215 4222 4237 4257 4255 4261 4262 4241 4245 4220 4343 4344 4351 4349 4353 4356 4357 4358 4359 4361 4365 4367 4368 4370 4373 4240 2323 2409 2461 2462 2463 2464 2465 5446 5298 5303 5344 5351 5352 5358 5361 5405 5406 5407 5409 5416 5388 5389 5390 5415 5491 5526 5527 5532 5506 35063 22264 22265 22263 30312 4378 30398 30399 30403 30416 30418 4375 4380 4381 4383 4385 5534 30031 30047 30056 30129 30148 30147 30253 30248 30277 35186 35038 35188 35146 36050 36133 35291 36144 30394 36040 30397 21299 21321 21442 22054 30074 30262 30263 30264 30274 2078 36129 36128 36187 35127 35139 30086 30131 35243 35257 36163 30055 30219 30229 30276 30020 36137 35315 30414 30353 30381 21585 21488 21489 21623 21593 21594 21609 21612 21897 21909 21953 21982 22014 22066 22065 22070 22091 22090 22178 22059 30041 3778 3976 3978 3864 3986 3987 4045 4052 4132 4136 4138 4141 4184 4187 4197 4287 4311 5055 5061 35286 30402 30405 30417 30024 35141 35166 35092 35191 35192 36011 36007 36094 36138

Neurological Devices

2

No

Worldwide Distribution - US Nationwide and the countries of: Germany, France, Bulgaria, India, Colombia, Tunisia, Saudi Arabia, Finland, Denmark, Brasil, Italy, Estonia, South Korea, Russia, Greece, Thailand, Israel, Poland, Turkey, Slovakia, Portugal, Switzerland, Hungary, Great Britain, Netherlands, China, Indonesia, Australia, Sweden, Spain, Iran, Singapore, Norway, Austria and Czech Republic.

Natus neurology Dantec KEYPOINT.NET 2.20. || Catalog/Part Numbers: || 9031A070103, 9031A006502, 9033A071103, 9033A072102, 9031A070102, || 9033A007402, 9033A071102, 9033A072103, 9033A0701, 9033A0711HA, || 9033A071101, 9031A070101, 9031A006401, 9031A006501, 9033A004701, || 9031A0032, 9033A0517, 9033A072101, 9031A0031, 9031A0701BV, || 9033A0044, 9033A0073AA, 9031A0063, 9033A0523, 9033A071143, || 9033A072143, 9031A006406, 9031A006506, 9031A070106, 9033A004606 || 9033A004706, 9033A007406, 9033A0537, 9033A0544, 9033A071106, || 9033A072106, 9033A0524, 9033A0711BV, 9033A007401, 9033A0516, || 9031A006403, 9031A006503, 9033A056403, 9033A0721BV, 9031A006402, || 9031A006405, 9031A051306, 9031A070105, 9033A0072, 9033A007301, || 9033A0711AA, 9033A0721AA || Product Usage: || Dantec KEYPOINT.NET Software 2.20 is installed on the Keypoint EMG System which is intended as an electro-physiological aid to assess diagnosis and prognosis and to monitor diseases of the central and peripheral nervous system. It can also be used to study functional aspects of nerves and muscles.

Model: , Affected: serial numbers are 17746 & 17747, 17752

Model: , Affected: serial numbers 002534, 002535, 452001642 and 452001643, 65536 and 65537

Model Catalog: 013926 (Lot serial: 013926030059); Model Catalog: 013926 (Lot serial: 013926030060); Model Catalog: 013926 (Lot serial: 013926030074); Model Catalog: 013926 (Lot serial: 013926030075)

QUANTUM SYSTEM

Warmette Blanket Cabinet Serial Numbers: 10216709, 10216711, 10218559, 10219214, 10219337, 10219338, 10219339, 10219340, 10219387, 10219388, 10219869, 10219870, 10219871, 10219872, 10219873, 1028880.   Warmette Dual Cabinet Serial Numbers: 10216713, 10216714, 10218500, 10218501, 10218522, 10218526, 10218528, 10218982, 10219257, 10219389, 10219390, 10220534, 10220536, 10220537, 10220538.

General Hospital and Personal Use Devices

2

No

Worldwide Distribution - US including NJ, NC, TX, IL, VA, NY, FL, CA, MS, WA, IN, and MA. and Internationally to Canada and Costa Rica.

Natus Warmette Blanket Cabinet and Warmette Dual Cabinet || The Natus Warmette Blanket Cabinet is designed to store and warm blankets and hospital linens; while, the Natus Warmette Dual Cabinet is designed to store and warm blankets and hospital linens in one compartment and fluids (irrigation and/or injection) in the other compartment within the storage times and warming temperatures recommended by the manufacturers of those items

SERIAL NUMBERS OF UNITS DISTRIBUTED TO US GOVERMENT CONSIGNEES:  12443, 12444, 12445, 12951, 13157, 13158, 13169, 14230, 16746, 16747, 16759, 16760, 16761, 16762, 16763, 16764, 16765, 16766, 16767, 16768, 16769, 16770, 16771, 16772, 16773, 16774, 16784, and 16785.  **************************************************************************************************** SERIAL NUMBERS OF UNITS DISTRIBUTED TO US CONSIGNEES:  040756-1, 040756-2, 10507, 10515, 10517, 10518, 10519, 10520, 10521, 10522, 10523, 10524, 10525, 10526, 10527, 10528, 10529, 10530, 10541, 10542, 10543, 10544, 10545, 10546, 10548, 10550, 10551, 10552, 10553, 10554, 10555, 10557, 10559, 10576, 10577, 10578, 10579, 10580, 10581, 10582, 10583, 10584, 10585, 10586, 10588, 10589, 10592, 10595, 10596, 10597, 10598, 10600, 10601, 10602, 10603, 10609, 10610, 10611, 10612, 10613, 10614, 10615, 10621, 10622, 10623, 10624, 10625, 10626, 10627, 10628, 10629, 10630, 10631, 10632, 10633, 10634, 10635, 10636, 10637, 10638, 10639, 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General Hospital and Personal Use Devices

2

No

Worldwide Distribution - US Nationwide and in the following countries: Argentina, Australia, Austria, Belgium, Bermuda, Canada, Colombia, Croatia, Denmark, Germany, Greece, Hungary, India, Indonesia, Israel, Italy, Japan, Kenya, Kuwait, Lithuania, Morocco, Norway, Peru, Philippines, Poland, Portugal, Romania, Russia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, United Kingdom, and Virgin Islands (British).

Second generation neoBLUE LED Phototherapy Light (neoBLUE 2) sold between 2003 and 2008. Catalog Part Number 010066. Top Assembly Part Numbers: 040906, 040904, 040756, 040758, 040658, 040680. || Product Usage: Device is used to provide treatment for neonatal hyperbilirubinemia.

md

Model Catalog: 006254 (Lot serial: up to xxxx004282.); Model Catalog: 006895 (Lot serial: up to xxxx004282.); Model Catalog: 006244 (Lot serial: up to xxxx004282.)

NeoBlue Blanket LED Phototherapy System;NEOBLUE BLANKET LED PHOTOTHERAPY SYSTEM

Model Catalog: 006895 (Lot serial: all lots. contact manufacturer); Model Catalog: 006244 (Lot serial: all lots. contact manufacturer); Model Catalog: 006254 (Lot serial: all lots. contact manufacturer)

neoBLUE blanket LED Phototherapy Systems;neoBLUE blanket LED Light Box