Medtronic

serial numbers: 301010, 301012, 301013, 301015, 301016, 301017, 301018, 301019, 301020, 301023, 301024, 301025, 301026, 301027, 301029 thru 301041, 301043 thru 301050, 301052, 301053, 301054, 301055, 301056, 301057, 301058, 301060, 301061, 301062, 301063, 301068 thru 301085, 301087, 301088, 301090, 301091, 301092, 301093, 301094, 301300, 301301, 301302, 301303, 301371 thru 301383, 301385, 301387, 301388, 301389, 301390, 301394, 301396, 301397, 301399 thru 301407, 301409, 301410, 301431 thru 301450, 301460, 301461, 301462, 301464, 301467 thru 301485, 301487 thru 301507, 301509 thru 301526, 301560 thru 301663, 301665 thru 301704, 301707 thru 301751, 301753, 301754, 301755, 301756, 301758 thru 301817, 301819 thru 301842, 301844 thru 302148, 302150 thru 302161,   PDBR400000 thru PDBR400127, PDBR400129 thru PDBR400835, PDBR400847 thru PDBR401104, PDBR401107 thru PDBR401178.

Cardiovascular Devices

2

No

Worldwide Distribution - USA (nationwide) including Puerto Rico, and Virgin Islands (U.S.) and the countries of: Argentina, Australia, Austria, Belarus, Belgium, Bulgaria, Canada, Chile, China, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, El Salvador, France, Georgia, Germany, Greece, Hong Kong, Hungary, Iceland, India, Indonesia, Israel, Italy, Jamaica, Japan, Korea, Kuwait, Latvia, Lebanon, Libya, Malaysia, Netherlands, New Zealand, Nicaragua, Norway, Pakistan, Poland, Portugal, Romania, Saudi Arabia, Singapore, Slovenia, Spain, Sweden, Switzerland, Taiwan, United Arab Emirates, United Kingdom, Venezuela, and Yemen.

Medtronic Pressure Display Box, Models 66000, 64000, 63000, 60000. It is capable of measuring pressure between -100 mmHg and +500 mmHg with an accuracy of +/-5 mmHg from -100 mmHg to +300 mmHg and +/-10 mmHg from +301 to +500 mmHg. The Pressure Display Box has an upper and lower alarm setting. The alarm will be activated when the pressure is equal to or beyond the set value. Manufacturer: Medtronic, Inc. 710 Medtronic Parkway, Minneapolis, MN 55431-5604. || Product Usage: This product is intended for use in displaying line pressures during cardiopulmonary bypass surgery.

Lot numbers: 2008070788, 2008070792, 2008070793, 2008070955, 2008080357, 2008080359, 2008080385, 2008080426, 2008080441, 2008080525, 2008080545, 2008081109, 2008081195, 2008090080, 2008090244, 2008090980, 2008091122, 2008091123, 2008091125, 2008100001, 2008100531, 2008100583, 2008100605, 2008100607, 2008101323, 2008101324, 2008101325, 2008101368, 2008101375, 2008101379, 2008101380, 2008110008, 2008110173, 2008110287, 2008110301, 2008110530, 2008110531, 2008110612, 2008110720, 2008110876, 2008110877, 2008110878, 2008111157, 2008111209, 2008111210, 2008120149, 2008120150, 2008120478, 2008120848, 2008120849, 2008120850, 2008120851, 2008121107, 2009010121, 2009010122, 2009010603, 2009010604, 2009010605, 2009010953, 2009010954, 2009010955, 2009011280, 2009011281, 2009011282, 2009011283, 2009011284, 2009020119, 2009020581, 2009020841, 2009020842, 2009020843, 2009030102, 2009030327, 2009030328, 2009030329, 2009030330, 2009030626, 2009030955, 2009031171, 2009031172, 2009040538, 2009040539, 2009040540, 2009040541, 2009040834, 2009041092, 2009041093, 2009041094, 2009050183, 2009050527, 2009050528, 2009050529, 2009050867, 2009050868, 2009050975, 2009050976, 2009060054, 2009060381, 2009060382, 2009060383, 2009060633, 2009060640, 2009060641, 2009060642, 2009060696, 2009061139, 2009070210, 2009070487, 2009070488, 2009070912, 2009071231, 2009080403, 2009080404, 2009080405, 2009080406, 2009080407, 2009081128, 2009081129, 2009081130, 2009081131, 2009081851, 2009090137, 2009090589, 2009090590, 2009090591, 2009091085, 2009100116, 2009100118, 2009100443, 2009100444, 2009100445, 2009100446, 2009100882, 2009100974, 2009100975, 2009100976, 2009100977, 2009100978, 2009101597, 2009101598, 2009102220, 2009102221, 2009102222, 2009110186, 2009110859, 2009110861, 2009111388, 2009112071, 2009120316, 2009120317, 2009120788, 2009120789, 2009120790, 2009120791, 2009121304, 2009121305, 2009121306, 2009121701, 2009121704, 2010010236, 2010010237, 2010010238, 2010011329, 2010011330, 2010011525, 2010011526, 2010011527, 2010021286, 2010022073, 2010022074, 2010031328, 2010031329, 2010031330, 2010031331, 2010031332, 2010031333, 2010032084, 2010032085, 2010032086, 2010032087, 2010032816, 2010032817, 2010032818, 2010032819, 2010032820, 2010033477, 2010033478, 2010033479, 2010040563, 2010040564, 2010040947, 2010040948, 2010040949, 2010041433, 2010050370, 2010050371, 2010050726, 2010050963, 2010051276, 2010051363, 2010060108, 2010060280, 2010060558, 2010060689, 2010061703, 2010061759, 2010062023, 2010062558, 2010062870, 2010062871, 2010070115, 2010071372, 2010071373, 2010071375, 2010071377, 2010071570, 2010071868, 2010080229, 2010080231, 2010080810, 2010080811, 2010080812, 2010081270, 2010081424, 2010081602, 2010081604, 2010081606, 2010082011, 2010082012, 2010082218, 2010082219, 2010082439, 2010090223, 2010090420, 2010090497, 2010090615, 2010090759, 2010090939, 2010090952, 2010091040, 2010091666, 2010091802, 2010092208, 2010092209, 2010092472, 2010092505, 2010100038, 2010100237, 2010100249, 2010100374, 2010100376, 2010100681, 2010101291, 2010101293, 2010101374, 2010101385, 2010101493, 2010101961, 2010101974, 2010110030, 2010110033, 2010110974, 2010120220, 2010120424, 2010120605, 2010120606, 2010121586, 2010121587, 2010122170, 2010122208, 2011010069, 2011010367, 2011010368, 2011011063, 2011011067, 2011011311, 2011011454, 2011011931, 2011020018, 2011020019, 2011020217, 2011020218, 2011020581, 2011020583, 2011020585, 2011020955, 2011020956, 2011021012, 2011021014, 2011021155, 2011021156, 2011021157, 2011021668, 2011021669, 2011021991, 2011021993, 2011022187, 2011022188, 2011030015, 2011030089, 2011030090, 2011030095, 2011030155, 2011030156, 2011030311, 2011030312, 2011031091, 2011031094, 2011031450, 2011031610, 2011031611, 2011031685, 2011032335, 2011032336, 2011040004, 2011040025, 2011040026, 2011040260, 2011040261, 2011040365, 2011040366, 2011040811, 2011040812, 2011041038, 2011041070, 2011041092, 2011041194, 2011041306, 2011041307, 2011041573, 2011041574, 2011041590, 2011041592, 2011050006, 2011050362, 2011050363, 2011050397, 2011050398, 2011050657, 2011050697, 2011051009, 2011051238, 2011051239, 2011051381, 2011051382, 2011051696, 2011051704, 2011060013, 2011060014, 2011060184, 2011060373, 2011060375, 2011060551, 2011060680, 2011060726, 2011060786, 2011061269, 2011061271, 2011062118, 2011062119, 2011062400, 2011062401, 2011062402, 2011070035, 2011070036, 2011070285, 2011070287, 2011070847, 2011070848, 200806C084, 200806C089, 200808C026, 200808C094, 200808C109, 200811C004, 200811C005, 200811C038, 200812C005, 200903C075, 200905C126, 200908C163, 200908C164, 200910C047, 200910C175, 200910C182, 200910C183, 200911C085, 200912C010, 201001C087, 201002C045, 201002C135, 201005C040, 201006C018, 201007C033, 201008C040, 201009C132, 201009C180, 201009C181, 201011C104, 201011C132, 201011C139, 201012C042, 201101C032, 201102C103, 201103C061, 201104C019, 201104C064, 201104C106, 201105C057.

Cardiovascular Devices

2

No

Worldwide Distribution - USA (nationwide) including Puerto Rico, and Virgin Islands (U.S.) and the countries of: Argentina, Australia, Austria, Belarus, Belgium, Bulgaria, Canada, Chile, China, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, El Salvador, France, Georgia, Germany, Greece, Hong Kong, Hungary, Iceland, India, Indonesia, Israel, Italy, Jamaica, Japan, Korea, Kuwait, Latvia, Lebanon, Libya, Malaysia, Netherlands, New Zealand, Nicaragua, Norway, Pakistan, Poland, Portugal, Romania, Saudi Arabia, Singapore, Slovenia, Spain, Sweden, Switzerland, Taiwan, United Arab Emirates, United Kingdom, Venezuela, and Yemen.

Medtronic Disposable Pressure Display Set, Models 61000, 61006, 62000, 62006. Sterilized by Ethylene Oxide. Non-pyrogenic. Coiled PVC tubing with threaded transducer dome (acrylic) with silicone diaphragm on proximal end. Product utilizes a stopcock on proximal and/or distal end. Distal end of tubing features a male luer port. Manufacturer: Medtronic, Inc. 710 Medtronic Parkway, Minneapolis, MN 55432-5604. || Product Usage: This product is intended for use in monitoring catheter, cannula, or line pressures associated with cardiopulmonary bypass equipment and/or related products.

Models 0K57R2, 0K82R15, 0M63R7, 0M68R6, 0N41R14, 0T50R5, 0V67R27, 0X52R3, 0Y35R, 0Y95R30, 0Z30R11, 1D41R16, 1F66R12, 1G59R1, 1J74R4, 1M90R8, 1P09R2, 2031R7, 2C88R8, 2C89R7, 2C90R7, 2C91R5, 2D61R2, 2D64R16, 2H08R3, 2K85R1, 2K87R1, 2K88R1, 2N90R9, 2T28R1, 3B74R2, 3T73R1, 3W29R, 4B42R5, 4C03R, 4D82R3, 4M55R, 4N04R, 4R43R, 5788R4, 5A45R3, 5B51R9, 5B94R, 5C33R2, 5C45R3, 5C92R9, 5D83R2, 5F68R1, 5G28R4, 5H65R, 5J00R2, 5P62R, 5W13R6, 5Z18R, 6G05R, 6J55R1, 6J88R4, 6J95R8, 6N12R, 6Q49R1, 6Q49R1, 6R08R, 6R09R, 6R44R2, 6S66R, 6S75R1, 6V25R, 6Y04R5, 6Y07R6, 6Y59R3, 7A69R4, 7A70R1, 7B56R1, CB0L44R16, CB0M02R5, CB0M79R8, CB1Q18R11, CB1S33R9, CB2D32R5, CB2W45R7, CB2W86R4, CB3K45R9, CB3K91R1, CB3M40R17, CB3Y46R9, CB3Y47R10, CB4800R18, CB4953R16, CB4958R16, CB4B68R8, CB4E78R7, CB4F45R15, CB4K64R6, CB4L83R4, CB4M60R2, CB4S43R9, CB4W10R10, CB4X84R, CB4Y71R14, CB4Z87R6, CB5A30R10, CB5F84R12, CB5J33R6, CB5L15R13, CB5L79R, CB5L90R16, CB5Q71R2, CB5Q74R1, CB5R04R1, CB5R46R5, CB5U81R, CB6A80R6, CB6G02R4, CB6H12R, CB6H45R4, CB6H76R, CB6H77R, CB6H78R, CB6J66R2, CB6J68R3, CB6J75R3, CB6L12R3, CB6L13R, CB6L14R, CB6L60R2, CB6M11R1, CB6Q15R, CB6Q16R1, CB6Q62R, CB6Q78R2, CB6S17R, CB6U12R, CB6U76R1, CB6X94R2, CB6X98R3, CB6Y02R6, CB6Y34R2, CB7C31R, DLP2X17R, HY0F32R17, HY2280R16, HY2U14R2, HY3U59R12, HY4A96R9, HY4V52R4, HY4V82R3, HY5D07R2, HY6B26R2, HY6G55R6, HY6G56R6, HY6H03R5, HY6H03R5, HY6J33R3, HY6J99R, HY6R36R1, HY6R36R1, HY6U70R2, HY6V34R2, HY6Z04R1, M331105H, M331105K, M336902L, M392810D, M392810E, M392811C, M392811D, M392811E, M440115G, M440115H, M440115J, M440115K, M440115L, M440129A, M440130A, M441002E, M443824F, M443825E, M492609A, M499301B, M530710A, M530710C, M530710D, M960208A, M960454B, P390806A, S330115A, SS6X67R1, SS6Z09R1, SSHY6E81R2, TL2H89R7, TL3Y45R1, TL3Z67R4, TL4E64R, TL4E66R10, TL4E66R10, TL5398R21, TL5C09R4, TL5M01R7, TL5R15R4, TL6A91R2, TL6C91R2, TL6D87R2, TL6H39R5, TL6W08R3, TL6X29R4, TL6X36R2, TL6X62R5, TL6Y92R, TL7A15R2.

Cardiovascular Devices

2

No

Worldwide Distribution - USA (nationwide) including Puerto Rico, and Virgin Islands (U.S.) and the countries of: Argentina, Australia, Austria, Belarus, Belgium, Bulgaria, Canada, Chile, China, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, El Salvador, France, Georgia, Germany, Greece, Hong Kong, Hungary, Iceland, India, Indonesia, Israel, Italy, Jamaica, Japan, Korea, Kuwait, Latvia, Lebanon, Libya, Malaysia, Netherlands, New Zealand, Nicaragua, Norway, Pakistan, Poland, Portugal, Romania, Saudi Arabia, Singapore, Slovenia, Spain, Sweden, Switzerland, Taiwan, United Arab Emirates, United Kingdom, Venezuela, and Yemen.

Medtronic Intersept Custom Tubing Pack, which are designed as specified by the user. The following models contain a Pressure Display Set. Sterilized by Ethylene Oxide. Non-pyrogenic. Manufacturer: Medtronic, Inc. 710 Medtronic Parkway, Minneapolis, MN 55432-5604. || Product Usage: This product is intended for use in monitoring catheter, cannula, or line pressures associated with cardiopulmonary bypass equipment and/or related products.

Lot Number: 0007244836 MODEL: LA6JR40K

Cardiovascular Devices

2

No

US Distribution including the states of NC, IA, IL and KS.

Medtronic Launcher Coronary Guide Catheter; MODEL: LA6JR40K

serial numbers: 5K0005, 5K0006, 5K0007, 5K0009, 5K0010, 5K0011, 5K0012, 5K0013, 5K0014, 5K0015, 5K0016, 5K0017, 5K0018, 5K0019, 5K0020, 5K0021, 5K0022, 5K0023, 5K0024, 5K0025, 5K0026, 5K0027, 5K0028, 5K0029, 5K0030, 5K0031, 5K0032, 5K0033, 5K0034, 5K0035, 5K0036, 5K0037, 5K0039, 5K0040, 5K0041, 5K0042, 5K0043, 5K0044, 5K0045, 5K0046, 5K0047, 5K0048, 5K0053, 5K0054, 5K0056, 5K0057, 5K0058, 5K0059, 5K0062, 5K0063, 5K0064, 5K0065, 5K0066, 5K0067, 5K0068, 5K0069, 5K0070, 5K0071, 5K0072, 5K0073, N5923, N5924, N5925, N5929, N5930, N5931, N5932, N5933, N6106, N6119, N6210, N6720, N7763, N7764, N7765, N7766, N7767, N7768, N7769, N7770, N7771, N7772, N7773, N7774, N7775, N7776, N7777, N7778, N7779, N7780, N7781, N7782, N7783, N7784, N7785, N7786, N7787, N8029, N8030, N8031, N8033, N8034, N8035, N8038, N8039, N8040, N8041, N8042, N8043, N8044, N8045, N8046, N8047, N8048, N8049, N8050, N8051, N8052, N8053, N8054, N8055, N8056, N8057, N8058, N8059, N8060, N8061, N8062, N8063, N8064, N8065, N8067, N8068, N8069, N8070, N8072, N8073, N8074.

Cardiovascular Devices

3

No

Worldwide Distribution - US (nationwide) and Internationally to Algeria, Australia, France, Germany, Greece, Iceland, Ireland, Israel, Italy, Lebanon, Malaysia, Martinique, Netherlands, Poland, Romania, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, and United Kingdom.

Medtronic CryoConsole, models 106A3, 106E2, and 106A2-K || For use in performing cardiac ablation procedures.