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Credits
Manufacturers
Firefly Medical, Inc.
Manufacturer Address
Firefly Medical, Inc., 320 E Vine Dr Ste 312, Fort Collins CO 80524-2332
Manufacturer Parent Company (2017)
Firefly Medical Inc.
Source
USFDA
2 Events
Recall of Device Recall IVEA
Recall of Device Recall IVEA
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2 devices in the database
Device Recall IVEA
Model / Serial
Serial Numbers - 100201, 100251, 100297, 100343, 100390, 100438, 100487, 100666, 100586, 100202, 100252, 100298, 100344, 100391, 100439, 100488, 100667, 100587, 100204, 100253, 100299, 100345, 100392, 100440, 100489, 100507, 100588, 100205, 100254, 100300, 100346, 100393, 100441, 100490, 100508, 100592, 100206, 100255, 100301, 100347, 100394, 100442, 100491, 100509, 100593, 100207, 100256, 100302, 100348, 100395, 100443, 100492, 100510, 100594, 100208, 100257, 100303, 100349, 100396, 100444, 100493, 100511, 100597, 100209, 100258, 100304, 100350, 100397, 100445, 100615, 100512, 100598, 100210, 100259, 100305, 100351, 100398, 100446, 100616, 100513, 100599, 100211, 100260, 100306, 100352, 100399, 100447, 100617, 100515, 100600, 100212, 100261, 100307, 100353, 100401, 100448, 100618, 100516, 100601, 100213, 100262, 100308, 100354, 100402, 100449, 100620, 100520, 100602, 100214, 100263, 100309, 100356, 100403, 100450, 100623, 100522, 100605, 100215, 100264, 100310, 100357, 100404, 100451, 100624, 100524, 100606, 100216, 100265, 100311, 100358, 100405, 100452, 100625, 100525, 100674, 100217, 100266, 100312, 100359, 100406, 100453, 100626, 100528, 100675, 100218, 100267, 100313, 100360, 100407, 100454, 100627, 100530, 100676, 100219, 100268, 100314, 100361, 100408, 100455, 100636, 100532, 100677, 100221, 100269, 100315, 100362, 100409, 100456, 100640, 100534, 100678, 100222, 100270, 100316, 100363, 100410, 100457, 100641, 100538, 100679, 100223, 100271, 100317, 100364, 100411, 100458, 100642, 100544, 100680, 100224, 100272, 100318, 100365, 100412, 100459, 100643, 100545, 100495, 100225, 100273, 100319, 100366, 100413, 100460, 100644, 100546, 100497, 100226, 100274, 100320, 100367, 100414, 100461, 100645, 100547, 100498, 100227, 100275, 100321, 100368, 100415, 100462, 100646, 100548, 100499, 100228, 100276, 100322, 100369, 100416, 100463, 100647, 100549, 100500, 100230, 100277, 100323, 100370, 100417, 100464, 100648, 100550, 100501, 100231, 100278, 100324, 100371, 100418, 100465, 100649, 100551, 100502, 100232, 100279, 100325, 100372, 100419, 100466, 100650, 100552, 100503, 100233, 100280, 100326, 100373, 100420, 100467, 100651, 100553, 100504, 100234, 100281, 100327, 100374, 100421, 100468, 100652, 100554, 100514, 100235, 100282, 100328, 100375, 100422, 100469, 100653, 100556 100519, 100236, 100283, 100329, 100376, 100423, 100472, 100654, 100558, 100521, 100237, 100284, 100330, 100377, 100424, 100474, 100655, 100562, 100523, 100238, 100285, 100331, 100378, 100425, 100475, 100656, 100564, 100526, 100239, 100286, 100332, 100379, 100426, 100476, 100657, 100565, 100527, 100240, 100287, 100333, 100380, 100428, 100477, 100658, 100569, 100529, 100241, 100288, 100334, 100381, 100429, 100478, 100659, 100570, 100531, 100242, 100289, 100335, 100382, 100430, 100479, 100660, 100571, 100533, 100243, 100290, 100336, 100383, 100431, 100480, 100661, 100572, 100535, 100244, 100291, 100337, 100384, 100432, 100481, 100779, 100574, 100536, 100245, 100292, 100338, 100385, 100433, 100482, 100473, 100576, 100537, 100246, 100293, 100339, 100386, 100434, 100483, 100662, 100579, 100539, 100247, 100294, 100340, 100387, 100435, 100484, 100663, 100581, 100540, 100249, 100295, 100341, 100388, 100436, 100485, 100664, 100583, 100541, 100250, 100296, 100342, 100389, 100437, 100486, 100665, 100584, 100542, 100555, 100689, 100736, 100784, 100831, 100878, 100926, 100973, 101021, 100557, 100690, 100737, 100785, 100832, 100879, 100927, 100974, 101022, 100559, 100691, 100738, 100786, 100833, 100880, 100928, 100975, 101023, 100560, 100692, 100739, 100787, 100834, 100881, 100929, 100976, 101024, 100561, 100693, 100740, 100788, 100835, 100882, 100930, 100977, 101025, 100563, 100694, 100741, 100789, 100836, 100883, 100931, 100978, 101026, 100566, 100695, 100742, 100790, 100837, 100884, 100932, 100979, 101027, 100567, 100696, 100743, 100791, 100838, 100885, 100933, 100980, 101028, 100573, 100697, 100744, 100792, 100839, 100886, 100934, 100982, 101029, 100575, 100698, 100745, 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100759, 100807, 100854, 100901, 100949, 100997, 101053, 100613, 100713, 100760, 100808, 100855, 100902, 100950, 100998, 101054, 100628, 100714, 100761, 100809, 100856, 100903, 100951, 100999, 101055, 100629, 100715, 100762, 100810, 100857, 100904, 100952, 101000, 101056, 100630, 100716, 100763, 100811, 100858, 100905, 100953, 101001, 101057, 100631, 100717, 100764, 100812, 100859, 100906, 100954, 101002, 101058, 100633, 100718, 100765, 100813, 100860, 100907, 100955, 101003, 101059, 100634, 100719, 100766, 100814, 100861, 100908, 100956, 101004, 101060, 100635, 100720, 100767, 100815, 100862, 100910, 100957, 101008, 101061, 100638, 100721, 100768, 100816, 100863, 100911, 100958, 101009, 101062, 100668, 100722, 100769, 100817, 100864, 100912, 100959, 101010, 101063, 100669, 100723, 100770, 100818, 100865, 100913, 100960, 101011, 101064, 100670, 100724, 100771, 100819, 100866, 100914, 100961, 101012, 101065, 100671, 100725, 100772, 100820, 100867, 100915, 100962, 101013, 101066, 100672, 100726, 100773, 100821, 100868, 100916, 100963, 101014, 101067, 100673, 100727, 100774, 100822, 100869, 100917, 100964, 101015, 101068, 100681, 100728, 100775, 100823, 100870, 100918, 100965, 101016, 100682, 100729, 100776, 100824, 100871, 100919, 100966, 101017, 100683, 100730, 100777, 100825, 100872, 100920, 100967, 101018, 100684, 100731, 100778, 100826, 100873, 100921, 100968, 101005, 100685, 100732, 100780, 100827, 100874, 100922, 100969, 101006, 100686, 100733, 100781, 100828, 100875, 100923, 100970, 101007, 100687, 100734, 100782, 100829, 100876, 100924, 100971, 101019, 100688, 100735, 100783, 100830, 100877, 100925, 100972, 101020
Product Classification
General Hospital and Personal Use Devices
Device Class
1
Implanted device?
No
Distribution
United States, Australia, Belgium, Canada, China, Germany, Hong Kong, Indonesia, Israel, Netherlands, Singapore, UAE
Product Description
IVEA Product Part Number 16100 Model 500A
Device Recall IVEA
Model / Serial
Product Part Number 16100. Serial Numbers 100200-101068, except for serial numbers within this range not released into final inventory for other reasons.
Product Classification
General Hospital and Personal Use Devices
Device Class
1
Implanted device?
No
Distribution
Worldwide Distribution -- USA and Canada.
Product Description
IVEA 500A || Intended for Med-Surg patient care.
Language
English
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