Viterion TeleHealthcare Llc

All units are affected. Serial Numbers A3303HA000201, A3303HA000202, A3303HA000203, A3303HA000204, A3303HA000205, A3304HA000206, A3304HA000207, A3304HA000208, A3304HA000209, A3304HA000210, A3305HA000211, A3305HA000212, A3305HA000213, A3305HA000214, A3305HA000215, A3306HA000216, A3306HA000217, A3306HA000218, A3306HA000219, A3306HA000220, A3310HA000221, A3310HA000222, A3310HA000223, A3310HA000224, A3310HA000225, A3404HA000226, A3404HA000227, A3404HA000228, A3404HA000229, A3404HA000230, A3404HA000231, A3404HA000232, A3404HA000233, A3404HA000234, A3404HA000235, A3404HA000236, A3404HA000237, A3404HA000238, A3404HA000239, A3404HA000240, A3404HA000241, A3404HA000242, A3404HA000243, A3404HA000244, A3404HA000245, A3404HA000246, A3404HA000247, A3404HA000248, A3404HA000249, A3404HA000250, A3602HA000252, A3602HA000253, A3602HA000254, A3602HA000255, A3602HA000256, A3602HA000257, A3602HA000258, A3602HA000259, A3602HA000260, A3602HA000261, A3602HA000262, A3602HA000263, A3602HA000264, A3602HA000265, A3602HA000266, A3701HA000267, A3701HA000268, A3701HA000269, A3701HA000270, A3701HA000271, A3701HA000272, A3701HA000273, A3701HA000274, A3701HA000275, A3701HA000276, A3701HA000277, A3701HA000278, A3701HA000279, A3701HA000280, A3701HA000281, A3701HA000282, A3701HA000283, A3701HA000284, A3701HA000285, A3701HA000286, A3701HA000287, A3701HA000288, A3701HA000289, A3701HA000290, A3701HA000291, A3818HA000292, A3818HA000293, A3818HA000294, A3818HA000295, A3818HA000296, A3818HA000297, A3818HA000298, A3818HA000299, A3818HA000300, A3818HA000301, A3818HA000302, A3818HA000303, A3818HA000304, A3818HA000305, A3818HA000306, A3818HA000307, A3818HA000308, A3818HA000309, A3818HA000310, A3818HA000311, A3818HA000312, A3818HA000313, A3818HA000314, A3818HA000315, A3818HA000316, A3905HA000317, A3905HA000318, A3905HA000319, A3905HA000320, A3905HA000321, A3905HA000322, A3905HA000323, A3905HA000324, A3905HA000325, A3905HA000326, A3905HA000327, A3905HA000328, A3905HA000329, A3905HA000330, A3905HA000331, A3905HA000332, A3905HA000333, A3905HA000334, A3905HA000335, A3905HA000336, A3905HA000337, A3905HA000338, A3905HA000339, A3905HA000340, A3905HA000341, A3D01HA000342, A3D01HA000343, A3D01HA000344, A3D01HA000345, A3D01HA000346, A3D01HA000347, A3D01HA000348, A3D01HA000349, A3D01HA000350, A3D01HA000351, A3D01HA000352, A3D01HA000353, A3D01HA000354, A3D01HA000355, A3D01HA000356, A3D01HA000357, A3D01HA000358, A3D01HA000359, A3D01HA000360, A3D01HA000361, A3D01HA000362, A3D01HA000363, A3D01HA000364, A3D01HA000365, A3D01HA000366, A3D01HA000367, A3D01HA000368, A3D01HA000369, A3D01HA000370, A3D01HA000371, A3D01HA000372, A3D01HA000373, A3D01HA000374, A3D01HA000375, A3D01HA000376, A3D01HA000377, A3D01HA000378, A3D01HA000379, A3D01HA000380, A3D01HA000381, A3D01HA000382, A3D01HA000383, A3D01HA000384, A3D01HA000385, A3D01HA000386, A3D01HA000387, A3D01HA000388, A3D01HA000389, A3D01HA000390, A4113HA000391, A4113HA000392, A4113HA000393, A4113HA000394, A4113HA000395, A4113HA000396, A4113HA000397, A4113HA000398, A4113HA000399, A4113HA000400, A4113HA000401, A4113HA000402, A4113HA000403, A4113HA000404, A4113HA000405, A4113HA000406, A4113HA000407, A4113HA000408, A4113HA000409, A4113HA000410, A4113HA000411, A4113HA000412, A4113HA000413, A4113HA000414, A4113HA000415, A4113HA000416, A4113HA000417, A4113HA000418, A4113HA000419, A4113HA000420, A4113HA000421, A4113HA000422, A4113HA000423, A4113HA000424, A4113HA000425, A4113HA000426, A4113HA000427, A4113HA000428, A4113HA000429, A4113HA000430, A4113HA000431, A4113HA000432, A4113HA000433, A4113HA000434, A4113HA000435, A4113HA000436, A4113HA000437, A4113HA000438, A4113HA000439, A4113HA000440, A4113HA000441, A4526MA000442, A4526MA000443, A4526MA000444, A4526MA000446, A4712MA000445, A4712MA000447, A4712MA000448, A4712MA000449, A4712MA000450, A4712MA000451, A4712MA000452, A4712MA000453, A4712MA000454, A4712MA000455, A4712MA000456, A4712MA000457, A4712MA000458, A4712MA000459, A4712MA000460, A4712MA000461, A4712MA000462, A4712MA000463, A4712MA000464, A4712MA000465.A4712MA000466, A4712MA000467, A4712MA000468, A4712MA000469, A4712MA000470, A4712MA000471, A4712MA000472, A4712MA000473, A4712MA000474, A4712MA000475, A4712MA000476, A4712MA000477, A4712MA000478, A4712MA000479, A4712MA000480, A4712MA000481, A4712MA000482, A4712MA000483, A4712MA000484, A4712MA000485, A4712MA000486, A4712MA000487, A4712MA000488, A4712MA000489, A4712MA000490, A4712MA000491, A4712MA000492, A4712MA000493, A4712MA000494, A4712MA000495, A4712MA000496, A4712MA000497, A4712MA000498, A4712MA000499, A4712MA000500, A4712MA000501, A4712MA000502, A4712MA000503, A4712MA000504, A4712MA000505, A4712MA000506, A5225MA000507, A5225MA000508, A5225MA000509, A5225MA000510, A5225MA000511, A5225MA000512, A5225MA000513, A5225MA000514, A5225MA000515, A5225MA000516, A5225MA000517, A5225MA000518, A5225MA000519, A5225MA000520, A5225MA000521, A5225MA000522, A5225MA000523, A5225MA000524, A5225MA000525, A5225MA000526, A5225MA000527, A5225MA000528, A5225MA000529, A5225MA000530, A5225MA000531, A5225MA000532, A5225MA000533, A5225MA000534, A5225MA000535, A5225MA000536, A5225MA000537, A5225MA000538, A5225MA000539, A5225MA000540, A5225MA000541, A5225MA000542, A5225MA000543, A5225MA000544, A5225MA000545, A5225MA000546, A5225MA000547, A5225MA000548, A5225MA000549, A5225MA000550, A5225MA000551, A5225MA000552, A5225MA000553, A5225MA000554, A5225MA000555, A5225MA000556, A5225MA000557, A5225MA000558, A5225MA000559, A5225MA000560, A5225MA000561, A5225MA000562, A5225MA000563, A5225MA000564, A5225MA000565, A5225MA000566, A5225MA000567, A5225MA000568, A5225MA000569, A5225MA000570, A5225MA000571, A5225MA000572, A5225MA000573, A5225MA000574, A5225MA000575, A5225MA000576, A5225MA000577, A5225MA000578, A5225MA000579, A5225MA000580, A5225MA000581, A5225MA000582, A5225MA000583, A5225MA000584, A5225MA000585, A5225MA000586, A5225MA000587, A5225MA000588, A5225MA000589, A5225MA000590 A5225MA000591, A5225MA000592, A5225MA000593, A5225MA000594, A5225MA000595, A5225MA000596, A5225MA000597, A5225MA000598, A5225MA000599, A5225MA000600, A5225MA000601, A5225MA000602, A5225MA000603, A5225MA000604, A5225MA000605, A5225MA000606, A5225MA000607, A5225MA000608, A5225MA000609, A5225MA000610, A5225MA000611, A5225MA000612, A5225MA000613, A5225MA000614, A5225MA000615, A5225MA000616, A5225MA000617, A5225MA000618, A5225MA000619, A5225MA000620, A5225MA000621, A5225MA000622, A5225MA000623, A5225MA000624, A5225MA000625, A5225MA000626, A5225MA000627, A5225MA000628, A5225MA000629, A5225MA000630, A5225MA000631, A5225MA000632, A5225MA000633, A5225MA000634, A5225MA000635, A5225MA000636, A5225MA000637, A5225MA000638, A5225MA000639, A5225MA000640, A5225MA000641, A5225MA000642, A5225MA000643, A5225MA000644, A5225MA000645, A5225MA000646, A5225MA000647, A5225MA000648, A5225MA000649, A5225MA000650, A5225MA000651, A5225MA000652, A5225MA000653, A5225MA000654, A5225MA000655, A5225MA000656, A5225MA000657, A5225MA000658, A5225MA000659, A5225MA000660, A5225MA000661, A5225MA000662, A5225MA000663, A5225MA000664, A5225MA000665, A5225MA000666, A5225MA000667, A5225MA000668, A5225MA000669, A5225MA000670, A5225MA000671, A5225MA000672, A5225MA000673, A5225MA000674, A5225MA000675, A5225MA000676, A5225MA000677, A5225MA000678, A5225MA000679, A5225MA000680, A5225MA000681, A5225MA000682, A5225MA000683, A5225MA000684, A5225MA000685, A5225MA000686, A5225MA000687, A5225MA000688, A5225MA000689, A5225MA000690, A5225MA000691, A5225MA000692, A5225MA000693, A5225MA000694, A5225MA000695, A5225MA000696, A5225MA000697, A5225MA000698, A5225MA000699, A5225MA000700, A5225MA000701, A5225MA000702, A5225MA000703, A5225MA000704, A5225MA000705, A5225MA000706, A5225MA000707, A5225MA000708, A5225MA000709, A5225MA000710, A5225MA000711, A5225MA000712, A5225MA000713, A5225MA000714, A5225MA000715, A5225MA000716, A5225MA000717, A5225MA000718, A5225MA000719, A5225MA000720, A5225MA000721, A5225MA000722, A5225MA000723, A5225MA000724, A5225MA000725, A5225MA000726, A5225MA000727, A5225MA000728, A5225MA000729, A5225MA000730, A5225MA000731, A5225MA000732, A5225MA000733, A5225MA000734, A5311MA000735, A5311MA000736, A5314MA000737, A5314MA000738, A5314MA000739, A5314MA000740, A5314MA000741, A5314MA000742, A5314MA000743, A5314MA000744, A5314MA000745, A5314MA000746, A5314MA000747, A5314MA000748, A5314MA000749, A5314MA000750, A5314MA000751, A5314MA000752, A5314MA000753, A5314MA000754, A5314MA000755, A5314MA000756, A5314MA000757, A5314MA000758, A5314MA000759, A5314MA000760, A5314MA000761, A5414MA000762, A5414MA000763, A5414MA000764, A5414MA000765, A5414MA000766, A5414MA000767, A5414MA000768, A5414MA000769, A5414MA000770, A5414MA000771, A5414MA000772, A5414MA000773, A5414MA000774, A5414MA000775, A5414MA000776, A5414MA000777, A5414MA000778, A5414MA000779, A5414MA000780, A5414MA000781, A5414MA000782, A5414MA000783, A5414MA000784, A5414MA000785, A5414MA000786, A5414MA000787, A5414MA000788, A5414MA000789, A5414MA000790, A5414MA000791, A5414MA000792, A5414MA000793, A5414MA000794, A5414MA000795, A5414MA000796, A5414MA000797, A5414MA000798, A5414MA000799, A5414MA000800, A5414MA000801, A5421MA000802, A5421MA000803, A5421MA000804, A5421MA000805, A5421MA000806, A5421MA000807, A5421MA000808, A5421MA000809, A5421MA000810, A5516MA000811, A5516MA000812, A5516MA000813, A5516MA000814, A5516MA000815, A5516MA000816, A5516MA000817, A5516MA000818, A5516MA000819, A5516MA000820, A5527MA000821, A5527MA000822, A5527MA000823, A5527MA000824, A5527MA000825, A5527MA000826, A5527MA000827, A5527MA000828, A5527MA000829, A5527MA000830, A5527MA000831, A5527MA000832, A5527MA000833, A5527MA000834, A5527MA000835, A5527MA000836, A5527MA000837, A5527MA000838, A5527MA000839, A5527MA000840, A5527MA000841, A5527MA000842, A5527MA000843, A5527MA000844, A5527MA000845, A5527MA000846, A5527MA000847, A5527MA000848, A5527MA000849, A5527MA000850, A5527MA000851, A5527MA000852, A5527MA000853, A5527MA000854, A5527MA000855, A5527MA000856, A5527MA000857, A5527MA000858, A5527MA000859, A5527MA000860, A5D15MA000891, A5D15MA000892, A5D15MA000893, A5D15MA000894, A5D15MA000895, A5D15MA000896, A5D15MA000897, A5D15MA000898, A5D15MA000899, A5D15MA000900, A5D15MA000901, A5D15MA000902, A5D15MA000903, A5D15MA000904, A5D15MA000905, A5D15MA000906, A5D15MA000907, A5D15MA000908, A5D15MA000909, A5D15MA000910, A5D15MA000911, A5D15MA000912, A5D15MA000913, A5D15MA000914, A5D15MA000915, A5D15MA000916, A5D15MA000917, A5D15MA000918, A5D15MA000919, A5D15MA000920, A5N08MA000861, A5N08MA000862, A5N08MA000863, A5N08MA000864, A5N08MA000865, A5N08MA000866, A5N08MA000867, A5N08MA000868, A5N08MA000869, A5N08MA000870, A5N08MA000871, A5N08MA000872, A5N08MA000873, A5N08MA000874, A5N08MA000875, A5N08MA000876, A5N08MA000877, A5N08MA000878, A5N08MA000879, A5N08MA000880, A5N08MA000881, A5N08MA000882, A5N08MA000883, A5N08MA000884, A5N08MA000885, A5N08MA000886, A5N08MA000887, A5N08MA000888, A5N08MA000889, A5N08MA000890, A6112MA000921, A6112MA000922, A6112MA000923, A6112MA000924, A6112MA000925, A6112MA000926, A6112MA000927, A6112MA000928, A6112MA000929, A6112MA000930, A6112MA000931, A6112MA000932, A6112MA000933, A6112MA000934, A6112MA000935, A6112MA000936, A6112MA000937, A6112MA000938, A6112MA000939, A6112MA000940, A6112MA000941, A6112MA000942, A6112MA000943, A6112MA000944, A6112MA000945, A6112MA000946, A6112MA000947, A6112MA000948, A6112MA000949, A6112MA000950, A6824MA000951, A6824MA000952, A6824MA000953, A6824MA000954, A6824MA000955, A6824MA000956, A6824MA000957, A6824MA000958, A6824MA000959, A6824MA000960

Cardiovascular Devices

2

No

Worldwide Distribution-USA (nationwide) and the United Kingdom.

Viterion TeleHealth Monitor Model Number V500; Product Codes 08832984 (US) and 02080468 (UK) - Physiological patient monitor (without arrhythmia detection or alarms). || Viterion V100, V100-BGM and V500 Telehealth Monitors transfer medical information.

All units are affected. List of affected serial numbers were provided as Excel spreadsheet due to the large volume.

Cardiovascular Devices

2

No

Worldwide Distribution-USA (nationwide) and the United Kingdom.

Viterion TeleHealth Monitor Model Number V100-BGM, Product Code 81842478 (US) -- Physiological patient monitor (without arrhythmia detection or alarms) . || Viterion V100, V100-BGM and V500 Telehealth Monitors transfer medical information.

All units are affected. List of affected serial numbers were provided as Excel spreadsheet due to the large volume.

Cardiovascular Devices

2

No

Worldwide Distribution-USA (nationwide) and the United Kingdom.

Viterion TeleHealth Monitor Model Number V100, Product Codes 09377512 (US) and 04480218 (UK). Physiological patient monitor (without arrhythmia detection or alarms). Viterion V100, V100-BGM and V500 Telehealth Monitors transfer medical information.

Serial Numbers: 22031, 22036, 22041, 22046, 22049, 22051, 22207, 22232, 22233, 22234, 22236, 22237, 22238, 22239, 22240, 22241, 22243, 22244, 22246, 22247, 22248, 22249, 22251, 22252, 23292, 23297, 23298, 23299, 23302, 23303, 23304, 23309, 23310, 23311, 23314, 23315, 23316, 23319, 23320, 23321, 23325, 23326, 23329, 23330, 23331, 23682, 23683, 23684, 23687, 23688, 23689, 23692, 23693, 23697, 23698, 23699, 23702, 23703, 23704, 23707, 23708, 23709, 23712, 23713, 23714, 23717, 23718, 23719, 23722, 23723, 23724, 23728, 23729, 19197, 19206, 19773, 22508, 25499, 16976, 16983, 16984, 16989, 16974, 16975, 16982, 16985, 16986, 16987, 16988, 16990, 17685, 18837, 18842, 19201, 19208, 19211, 19220, 19221, 19225, 19226, 19229, 19231, 19265, 19600, 19601, 19605, 19615, 19616, 19620, 19625, 19626, 19635, 19641, 19784, 21007, 21010, 21011, 21322, 21329, 21335, 21340, 21343, 21378, 21395, 22050, 23197, 23198, 23199, 23204, 23214, 23293, 23294, 24484, 24485, 24487, 24489, 24494, 24495, 24496, 24500, 24501, 24503, 24515, 24529, 24849, 24859, 24869, 24879, 24884, 24899, 24904, 24909, 24919, 25084, 12510, 13215, 15024, 23277,  23982, 23983, 23984, 23989, 23990, 23992, 23993, 23994, 23997, 23998, 23999, 24002, 24003, 24004, 24007, 24008, 24012, 24013, 24017, 24018, 24019, 24022, 24023, 24027, 24028, 25482, 25483, 25487, 25488, 25492, 25493, 25497, 25498, 25502, 25503, 25507, 25508, 25514, 25515, 25516,  25517, 25518, 25519, 25522, 25523, 25524, 25529, 25530, 25531, 2120, 19264, 19287, 19621, 19779, 20747, 21009, 21330, 21342, 21348, 21990, 21998, 22077, 22170, 22253, 22392, 22419, 22422, 22424, 23194, 23202, 23235, 23236, 23252, 23272, 23278, 23416, 23427, 23530, 23727, 23991, 23995, 24001, 24009, 24118, 24132, 24139, 24150, 24482, 24486, 24490, 24491, 24492, 24498, 24508, 24730, 24864, 25494, 25619, 26551, 26556, 26655, 19606, 19610, 19611, 20755, 20765, 20769, 20777, 20778, 20779, 20782, 20783, 20784, 20787, 20788, 20789, 20792, 20793, 20794, 20997, 20998, 20999, 21000, 21001, 21002, 21003, 21004, 21005, 21006, 21012, 21013, 21014, 21015, 21016, 21297, 21307, 21312, 21331, 21332, 21333, 21334, 21336, 21337, 21338, 21339, 21344, 21345, 21346, 21347, 21352, 21353, 21357, 21358, 21362, 21363, 21373, 21377, 21383, 21391, 22383,  22388, 22393, 22398, 22402, 22403, 22408, 22421, 22426, 22486, 23232, 23233, 23234, 23239, 23240, 23241, 23244, 23245, 23246, 23249, 23250, 23251, 23254, 23255, 23256, 23259, 23260, 23261, 23264, 23265, 23266, 23269, 23270, 23271, 23274, 23275, 23276, 23279, 23280, 23281, 23482, 23483, 23484, 23487, 23488, 23494, 23495, 23496, 23497, 23498, 23499, 23502, 23503, 23504, 23507, 23508, 23509, 23512, 23513, 23514, 23517, 23518, 23519, 23522, 23523, 23524, 23527, 23528, 23529, 23784, 23785, 23786, 23790, 23791, 23795, 23796, 23800, 23801, 23805, 23806, 23810, 23811, 23815, 23816, 23820, 23821, 23825, 23826, 23830, 23831, 24089, 24090, 24094, 24095, 24099, 24100, 24103, 24104, 24109, 24113, 24114, 24123, 24124, 24127, 24128, 24134, 24135, 24140, 24146, 24148, 24149, 24151, 24153, 24154, 24155, 24156, 24161, 24163, 24164, 24166, 24168, 24169, 24171, 24173, 24174, 24176, 24178, 24179, 24181, 24505, 24506, 24510, 24511, 24512, 24513, 24520, 24521, 24525, 24526, 24530, 24531, 24587, 24588, 24589, 24590, 24591, 24592, 24593, 24594, 24595, 24596, 24597, 24598, 24599, 24600, 24601, 24602, 24603, 24604, 24605, 24606, 24607, 24608, 24609, 24612, 24613, 24614, 24615, 24616, 24622, 24623, 24624, 24625, 24626, 24627, 24628, 24629, 24630, 24631, 24885, 24889, 24890, 24893, 24894, 24898, 24903, 24908, 24912, 24913, 24917, 24918, 24922, 24924, 25083, 25585, 25586, 25590, 25591, 25592, 25593, 25610, 25611, 25615, 25616, 25622, 25623, 16934, 1361, 1495, 1499, 1525, 3546, 3940, 6769, 6784, 7771, 7778, 7799, 7800, 7808, 7809, 8125, 8131, 8141, 8680, 8699, 8701, 8717, 8721, 8736, 8873, 8880, 8892, 8893, 8981, 8989, 8990, 8995, 10175, 10179, 10181, 10183, 10184, 10217, 10218, 10221, 10232, 10233, 10234, 10235, 10237, 10238, 10240, 10241, 10408, 10462,  10463, 10465, 10513, 10519, 10944, 10949, 10997, 10999, 11001, 11003, 11012, 11014, 11042, 11052, 11057, 11059, 11061, 11074, 11076, 11087, 11089, 11657, 11658, 11677, 11700, 11701, 11724, 11766, 11770, 11784, 11786, 11792, 11796, 11802, 11803, 11804, 11805, 11806, 11837, 11838, 11840, 11841, 11975, 11979, 11980, 11987, 11989, 11993, 11994, 11995, 11999, 12000, 12001, 12012, 12013, 12014, 12024, 13350, 13403, 13405, 13433, 13435, 13437, 13438, 13439, 13440, 13458, 13459, 13460, 22069, 22070, 22071, 22074, 22076, 22080, 22081, 22082, 22085, 22086, 22087, 22090, 22091, 22092, 22096, 22384, 22385, 22386, 22389, 22390, 22391,  22394, 22395, 22399, 22400, 22401, 22409, 22410, 22414, 22415, 23237, 23238, 23243, 23248, 23253, 23258, 23263, 23267, 23268, 23273, 23301,  23307, 23308, 23312, 23313, 23317, 23318, 23322, 23323, 23327, 24929, 24930, 24931, 25089, 25090, 25091, 25094, 25095, 25096, 25099, 25100, 25101, 25104, 25105, 25106, 25109, 25110, 25111, 25114, 25115, 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25156, 25157, 25158, 25159, 25160, 25161, 25162, 25163, 25164, 25165, 25166, 25167, 25168, 25169, 25170, 25171, 25172, 25173, 25174, 25175, 25176, 25177, 25178, 25179, 25180, 25181, 1179, 1723, 2756, 1122, 2067, 2068, 2413, 2563, 2564, 3234, 3235, 3244, 3245, 3248, 3249, 3416, 3419, 3429, 3435, 22518, 25600, 25601, 25605, 25606, 25609, 5657, 5667, 15276, 15277, 15278, 15279, 15280, 15281, 15297, 15298, 15299, 15300, 15301, 15307, 15308, 15309, 15310, 15311, 15312, 15313, 15314, 15315, 15316, 15327, 15328, 15329, 15330, 15337, 15338, 15339, 15340, 15341, 16786, 16787, 16788, 16801, 16802, 16803, 16804, 16805, 16806, 16807,  16808, 16809, 16810, 16811, 16818, 17004, 17005, 17006, 17009, 17010, 17011, 17029, 17030, 17031, 17039, 17040, 17041, 17072, 17073, 17074, 17079, 17080, 17081, 17097, 17098, 17099, 17112, 17113, 17114, 17124, 17125, 17126, 17137, 17138, 17139, 17877, 17878, 17879, 17880, 17881,  17882, 17883, 17884, 17885, 17886, 17887, 17888, 17889, 17890, 17891, 17892, 17893, 17894, 17895, 17896, 17911, 17917, 17918, 17919, 17920, 17956, 17957, 17958, 17962, 17963, 17992, 17993, 17994, 17995, 17997, 17998, 17999, 18002, 18007, 18008, 18009, 18012, 18013, 18014, 18017, 18018, 18023, 18024, 18027, 18028, 18029, 18032, 18033, 18034, 18037, 18038, 18039, 18042, 18043, 18044, 18750, 18751, 18752, 18753, 18755, 18756, 18757, 18758, 18759, 18760, 18761, 18762, 18763, 18764, 18765, 18766, 18767, 18768, 18769, 18770, 18771, 18773, 18774, 18775, 18776, 18779, 18780, 18781, 18782, 18784, 22202, 22235, 22245, 22250, 22254, 22255, 22256, 22258, 22259, 22260, 22261, 22262, 22263, 22264, 22265, 22266, 22267, 22268, 22269, 22270, 22271, 22272, 22274, 22275, 22276, 22278, 22279, 22280, 22281, 22298, 22509, 22510, 22511, 23782, 23783,  23787, 23788, 23792, 23793, 23797, 23802, 23803, 23807, 23808, 23813, 23818, 23823, 23828, 24497, 24502, 24507, 24516, 24517, 24518, 24522, 24527, 24882, 24883, 24887, 24888, 24895, 24896, 24900, 24901, 24905, 24906, 24910, 24911, 24914, 24915, 24916, 24920, 24921, 24923, 24925, 24926, 25085, 25086, 22522, 22527, 22528, 22529, 12721, 12729, 12730, 12731, 12739, 12740, 12741, 15129, 15130, 15131, 15136, 15137, 15138, 15139, 15140, 15141, 15142, 15143, 15144, 15145, 17786, 17791, 17795, 17800, 17806, 17811, 17816, 17820, 17825, 18700, 18701, 18705, 18706, 18710, 18711, 18715, 18716, 18720, 18721, 18745, 18746, 18747, 18748, 18749, 18754, 22513, 22514, 22515, 22516, 22530, 24582, 24583, 24584, 24585, 24586, 24610, 24611, 24618, 24621, 24684, 24685, 24686, 24689, 24690, 24691, 24694, 24695, 24696, 24699, 24700, 24701, 24704, 24705, 24706, 24709, 24710, 24711, 24712, 24713, 24714, 24717, 24718, 24719, 24722, 24723, 24724, 24727, 24728, 22517, 17730, 17731, 17735, 17736, 17741, 17745, 17746, 17750, 17751, 17755, 17760, 17765, 17770, 17775, 17776, 18796, 18797, 18802, 18806, 18807, 18812, 18816, 18817, 18822, 18831, 20750, 20751, 20756, 20760, 20761, 20766, 20775, 20776, 20785, 20786, 22396, 22404, 22405, 22406, 22411, 22412, 22413, 22420, 22425, 22485, 22519, 23282, 23283, 23284, 23285, 23286, 23295, 23296, 23817, 23822, 23827, 24847, 24848, 24852, 24853, 24854, 24857, 24858, 24862, 24863, 24867, 24868, 24872, 24873, 24877, 24878, 25484, 25486, 25490, 25491, 25495, 25496, 25500, 25501, 25505, 25506, 25510, 25511, 26534, 26539, 26656, 26659, 26660, 26661, 26664, 26665, 26667, 26668, 26669, 26670, 26672, 26673, 26674, 3462, 3466, 3468, 3469, 3470, 3471, 3472, 3473, 3474, 4532, 4533, 4537, 4538, 4542, 4805, 4806, 4807, 4809, 4812, 4813, 4814, 6056, 6057, 6058, 6059, 6060, 6062, 6638, 6640, 6643, 6646, 6647, 6648, 6649, 6657, 6667, 6669, 6670, 6944, 6946, 6950, 9621, 9627, 9632, 9633, 9641, 9657, 9662, 10048, 10182, 10197, 10198, 10199, 10227, 10230, 10455, 10472, 10474, 10475, 10476, 10537, 10540, 10905, 10926, 10928, 11000, 11015, 11060, 11100, 11253, 11254, 11255, 11256, 11266, 11299, 11300, 11301, 11848, 11857, 11868, 11880, 11882, 11883, 11893, 11897, 14909, 14969, 16356, 16364, 16365, 16366, 16367, 16368, 16369 16370, 16384, 16385, 16386, 16387, 16388, 16389, 16390, 16615, 16616, 16617, 16618, 16619, 16620, 16972, 16973, 16977, 16978, 16979, 16980, 16981, 17930, 17931, 17935, 17936, 17940, 17941, 17945, 17946, 17950, 17951, 17955, 17967, 17968, 17972, 17973, 21298, 21299, 21300, 21301, 21308, 21309, 21310, 21311, 21313, 21314, 21315, 21316, 21327, 21328, 21341, 22520, 22521, 23207, 23208, 23212, 23213, 23217, 23218, 23219, 23222, 23227, 23401, 23412, 23413, 23414, 23415, 23421, 23422, 23423, 23424, 23425, 23426, 23428, 23429, 23430, 23431, 23432, 23457, 23462, 23467, 23472, 23477, 26632, 26633, 26642, 26647, 26648, 26666, 26671,  26675, 26676, 26680, 26681, 143, 166, 219, 220, 334, 336, 656, 3767, 3892, 3893, 3894, 3895, 3896, 3898, 3901, 3902, 3903, 3904, 3905, 3906, 3907, 3908.3909, 3922, 3923, 4967, 6570, 11757, 12624, 12627, 12628, 12629,  12630, 12631, 12632, 12633, 12634, 12635, 12636, 12637, 12638, 12639, 12640, 12641, 12642, 12643, 12645, 12646, 13601, 13842, 14541, 14608, 15159, 15363, 15364, 15365, 15366, 15399, 15407, 15427, 15430, 15431, 15435, 15436, 15632, 15633, 15634, 15635, 15636, 15647, 15648, 15649, 15650, 15651, 15652, 15653, 15654, 15655, 15656, 15657, 15658, 15659, 15660, 15661, 15668, 15679, 15680, 15681, 15682, 15683, 15684, 15685, 15686, 15687, 15688, 15689, 15690, 15691, 15692, 15693, 15694, 15695, 15696, 16532, 16581, 16602, 16603, 16604, 16605, 16606, 16607, 16608, 16609, 16610, 16666, 16667, 16668, 16669, 16670, 16671, 16677, 16678, 16679, 16680, 16681, 16687, 16688, 16689, 16690, 16691, 16692, 16693, 16694, 16695, 16812, 16813, 16814, 16815, 16816, 16817, 16819, 16820,  16821, 16822, 16823, 16824, 16825, 16826, 16827, 16828, 16829, 16830, 16831, 16836, 16837, 16838, 16839, 16840, 16851, 16852, 16853, 16855, 16873, 18785, 18790, 18795, 18800, 18805, 18810, 18811, 18815, 18820, 18821, 18825, 18826, 18830, 19274, 19282, 19284, 19288, 19289, 19295, 19296, 19749, 19750, 19751, 19754, 19755, 19756, 19759, 19760, 19761, 19764, 19765, 19766, 19769, 19770, 19771, 19774, 19775, 19776, 19780,  19781, 19785, 19786, 19789, 19790, 19791, 19794, 19795, 19796, 20247, 20248, 20249, 20250, 20251, 20252, 20253, 20254, 20255, 20256, 20257, 20258, 20260, 20261, 20262, 20263, 20265, 20266, 20267, 20268, 20270, 20271, 20272, 20273, 20275, 20276, 20277, 20278, 20280, 20281, 20282, 20283, 20285, 20286, 20287, 20288, 20290, 20291, 20292, 20293, 20295, 20296, 22052, 22053, 22057, 22058, 22062, 22063, 22067, 22068, 22072, 22073, 22078, 22079, 22083, 22084, 22088, 22089, 22093, 22094, 22098, 22099, 22382, 22387, 22397, 22407, 22416, 22523, 22524, 22525, 22526, 22531, 24835, 24836, 24840, 24841, 24845, 24846, 24850, 24855, 24856, 24860, 24861, 24865, 24866, 24870, 24871, 24874, 24875, 24876, 24880, 24881, 24928, 25088, 25093, 25098, 25103, 25108, 25113, 25118, 25123, 12618, 12619, 12620, 12622, 12623, 12625, 12644, 12651, 12652, 12653, 15146, 15147, 15148, 15149, 15150, 15151, 15152, 15153, 15154, 15155, 15156, 15157, 15158, 15160, 15161, 15162, 15163, 15164, 15165, 15168, 17650, 17661, 17675, 17681, 17686, 17690, 17695, 17698, 17699, 17700, 17701, 17717, 17718, 17722, 17723, 18786, 18787, 18791, 18792, 18801, 18835, 18836, 18840, 18841, 18845, 19200, 19205, 19215, 19218, 19230, 22417, 22418, 22482, 22483, 22484, 24131, 24136, 24142, 24147, 24152, 24157, 24162, 24167, 24172, 24177, 25132, 25133, 25134, 25137, 25139, 25140, 25143, 25144, 25145, 25149, 15662, 15663, 15665, 15669, 15670, 20749, 20754, 20757, 20758, 20759, 20764, 20767, 20768, 20773, 20774, 3711, 18397, 18398, 18402, 18403, 18407, 18408, 18412, 18413, 18414, 18417, 18418, 18419, 18422, 18423, 18424, 18427, 18428, 18429, 18432, 18433, 18434, 18437, 18438, 18439, 18442, 18443, 18444, 18511, 18516, 18542, 19748, 19753, 19757, 19758, 19763, 19768, 19778, 19783, 19788, 19793, 21017, 21018, 21019, 21020, 21021, 21022, 21023, 21024, 21025, 21026, 23287, 23288, 23289, 23290, 23291, 24133, 24137, 24138, 24143, 24144, 24145, 26640, 26652, 26653, 26654, 26679, 15166, 15167, 15169, 15170, 15204, 15205, 16315, 16471, 16477, 21317, 21368, 22095, 22097, 22100, 22101, 22132, 16478, 16479, 22171, 22172, 22174, 22175, 22176, 22177, 22179, 22180, 22181, 22182.

Cardiovascular Devices

2

No

(USA) Nationwide Distribution

Viterion 100-BGM TeleHealth Monitor, Model No. 09377512, Product Code/Part No. 81842478, Bayer HealthCare LLC 555 White Plains Road, Tarrytown, NY 10591-5097 USA --- Manufactured in Japan for Bayer HealthCare LLC -- Common Name: Viterion100 TeleHealth Monitor -- Classification Name: Monitor, Physiological, Patient (Without Arrhythmia Detection or Alarms) [ref. 21CFR 870.2300] || Product Usage: || The Viterion 100 TeleHealth Monitor and related Data Server are physiological monitoring systems. The systems collect, accumulate and periodically transmit patient vital signs and other physiological data from a patient who may be remote from the healthcare practitioner to the practitioner, and provides communication between the patient and the practitioner. The physiological monitoring instrument, selected by the healthcare practitioner, operates in conjunction with the Patient Terminal located in the patients home, a hospital room, nursing home, or other healthcare facility. The Patient Terminal connects to the server via a conventional or cellular telephone line. The system is not a real-time monitoring system, and there is no requirement that a health care professional review the information at any specific interval or provide immediate feedback to patients. Rather, the system is intended to aid the physicians longer term management of patients. Patients are expected to take the same short term actions in response to physiological data as they ordinarily would in the absence of the Tele Health Monitor.