SYNCHRON

All serial numbers. PN Numbers: A10405 (UniCel DxC 600); A11810 (UniCel DxC 600 PRO); A27318 (UniCel DxC 600i); A11816 (UniCel DxC 800); A11812 (UniCel DxC 800 PRO); A59102 (UniCel DxC 880i); A64903 (UniCel DxC 680i); A64871 (UniCel DxC 660i); A64871 (UniCel DxC 860i); and A64935 (UniCel DxC 860i).

Clinical Chemistry and Clinical Toxicology Devices

1

No

Worldwide Distribution -- USA and Canada.

Beckman Coulter UniCel DxC Synchron Clinical System ISE Flow Cell. || PN Numbers: A10405 (UniCel DxC 600); A11810 (UniCel DxC 600 PRO); A27318 (UniCel DxC 600i); A11816 (UniCel DxC 800); A11812 (UniCel DxC 800 PRO); A59102 (UniCel DxC 880i); A64903 (UniCel DxC 680i); A64871 (UniCel DxC 660i); A64871 (UniCel DxC 860i). || Intended for the in vitro determination of a variety of general chemistries, therapeutic drugs, and other chemistries of clinical interest in biological fluids such as serum, plasma, urine, or cerebrospinal fluid.

All Serial Numbers

Clinical Chemistry and Clinical Toxicology Devices

1

No

Worldwide Distribution - USA: including the states of AK, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, VA, WA, WI, AND WV and the country of Canada.

Closed Tube Aliquotter (CTA) for UniCel || DxC 600i, Part Number: A25637, Domestic; A25633, International || The UniCel Synchron Clinical Systems are fully automated, computer controlled clinical chemistry analyzers designed for the in vitro determination of a variety of general chemistries, therapeutic drugs, and other chemistries. Analysis can be performed on serum, plasma, urine, or cerebrospinal fluid (CSF) and whole blood (sample type is chemistry dependent).

Clinical Chemistry and Clinical Toxicology Devices

2

No

Worldwide Distribution: (USA) Nationwide including KY; and the country of Canada.

UniCel DxC 880i, 860i,680i and 660i Synchron Access Clinical Systems || The Unicel DxC Integrated Workstation takes samples loaded from a single point of entry through a UCTA (UniCel Closed Tube Aliquotter). The UCTA functions as the sample processing manager by aliquotting and routing samples to the DxC and the Dxl analyzers according to the programming requirements

Model N118, serial numbers: 564225, 568144, 569074, 569104, 569150, 569690, 569737, 569866, 569996, 569998, 570003, 578083, 578441, 578668, 578673, 578746, 578748, 578758, 578761, 578800, 578810, 578822, 578834, 578845, 578855, 578893, 578918, 578921, 578924, 578944, 578945, 578953, 578956, 578975, 578978, 578984, 579024, 579031, 579043, 579055, 579070, 579085, 579100, 579105, 579123, 579200, 579228, 579448, 579502, 579519, 579587, 579595, 579605, 579624, 579707, 579773, 579776, 579780, 579789, 579793, 579794, 579795, 579798, 579800, 579803, 579809, 579810, 579811, 579813, 579817, 579818, 579819, 579844, 579857, 579862, 579866, 579868, 579879, 579880, 579894, 579897, 579900, 579906, 579914, 579916, 579920, 579927, 580007, 580315, 580337, 580379, 580391, 581909, 581922, 581960, 581966, 581974, 581999, 582012, 582025, 582028, 582052, 582068, 582069, 582094, 582099, 582101, 582105, 582131, 582137, 582152, 582159, 582200, 582225, 582278, 582279, 582280, 582313, 582317, 582329, 582330, 582347, 582365, 582402, 582405, 582407, 582412, 582447, 582457, 582471, 582495, 582508, 582551, 582564, 582589, 582590, 582727, 582787, 582820, 582823, 582827, 582830, 582863, 582882, 582887, 582918, 582945, 582958, 582961, 582966, 582993, 582997, 582998, 583006, 583020, 583021, 583034, 583038, 583039, 583052, 583058, 583060, 583076, 583077, 583079, 583093, 583094, 583117, 583140, 583141, 583148, 583185, 583217, 583233, 583245, 583250, 583251, 583259, 583262.  Model N119, serial numbers: 058537, 058899, 058989, 169937, 171259, 172468, 173571, 174731, 175333, 180258, 181817, 181944, 182893, 184121, 185550, 186643, 186723, 188751, 189460, 190554, 190724, 192369, 193725, 194834, 196314, 196319, 196944, 197243, 197340, 197530, 198559, 198563, 198646, 199247, 199557, 200322, 200333, 201344, 201447, 202619, 203198, 206554, 206562, 207971, 208920, 208977, 209055, 209225, 947264, 947354, 948235, 948250, 948409, 948531, 948542, 948939, 949460, 949510, 949529, 949824, 949894, 953082, 953134, 953436, 953524, 953544, 953551, 954004, 954017, 954157, 954178, 954305, 954312, 954317, 954339, 954363, 954364, 954403, 954422, 954672, 954678, 954686, 954700, 954944, 954946, 954967, 955012, 955013, 955026, 955627, 955632, 955635, 955670, 955677, 955682, 955683, 955707, 955709, 955754, 955766, 955952, 955961, 955962, 955987, 955990, 955992, 956007, 956035, 956041, 956047, 956053, 956347, 956358, 956426, 956477, 956765, 957266, 957301, 957304, 957316, 957369, 957422, 957425, 957437, 957474, 957476, 957487, 957521, 957608, 957878, 957969, 958152, 958298, 958529, 958535, 958555, 958563, 958583, 958616, 958683, 958775, 958837, 958838, 958898, 958901, 958902, 959046, 959070, 959078, 959098, 959101, 959169, 959183, 959188, 959200, 959225, 959279, 959327, 959341, 959363, 959367, 959391, 959395, 959398, 959401, 959827, 960273, 960275, 960278, 960282, 960290, 960291, 960454, 960484, 960489, 960495, 960498, 960500, 960503, 960527, 960545, 960552, 960563, 960571, 960575, 960582, 960584, 960586, 960687, 960701, 960710, 960712, 960717, 960736, 960747, 960882, 960903, 960906, 960932, 960972, 960975, 960976, 960979, 961036, 961041, 961046, 961047, 961049, 961091, 961092, 961093, 961101, 961102, 961108, 961163, 961175, 961182, 961184, 961189, 961190, 961202, 961204, 961257, 961261, 961266, 961273, 961274, 961282, 961286, 961291, 961387, 961389, 961398, 961399, 961407, 961412, 961416, 961427, 961445, 961451, 961457, 961462, 961467, 961470, 961474, 961483, 961486, 961689, 961690, 961738, 961742, 961746, 961751, 961752, 961798, 961800, 961855, 961860, 961861, 961869, 961872, 961886, 961897, 961901, 961907, 961917, 962032, 962359, 962381, 962428, 962465, 962797, 963255, 963268, 963280, 963290, 963828, 964028, 964037, 964043, 964047, 964100, 964117, 964128, 964160, 964252, 964265, 964271, 964659, 964733, 965297, 966005, 966140, 968984, 968988, 968996, 968998, 969006, 969007, 969044, 969049, 969062, 969109, 969117, 969174, 970703, 970710, 970747, 970755, 970766, 970799, 970813, 970816, 970822, 970827, 970849, 970855, 970860, 970873, 970876, 970885, 970888, 970891, 970892, 970898, 970971, 971013, 971016, 971041, 971047, 971054, 971443, 971469, 971491, 971494, 972130, 972146, 972160, 972166, 972418, 972423, 972516, 972529, 972536, 972539, 972543, 972597, 972600, 972601, 972602, 972607, 972614, 972642, 972882, 972883, 972884, 972916, 972920, 972922, 972925, 972927, 972932, 972947, 972963, 973325, 973333, 973340, 973345, 973348, 973452, 973454, 973462, 973467, 973479, 973496, 973513, 973590, 973591, 973709, 973728, 973736, 973738, 973749, 973750, 974239, 974245, 974252, 974256, 974260, 974269, 974285, 974288, 974290, 974297, 974307, 974379, 974398, 974423, 974432, 974527, 974560, 974564, 974584, 974590, 974598, 974636, 975007, 975021, 975039, 975051, 975059, 975061, 975160, 975164, 975200, 975476, 975490, 975492, 975599, 975607, 975683, 975730, 975813, 975830, 975836, 975901, 976453, 976454, 976455, 976457, 976462, 976492, 976493, 976499, 976503, 976507, 976510, 976515, 976524, 976540, 976542, 976580, 976582, 976843, 976853, 976863, 976869, 976871, 976904, 976924, 976926, 976932, 977014, 977030, 977034, 977050, 977122, 977126, 977132, 977150, 977152, 977157, 977163, 977176, 977178, 977179, 977190, 977191, 977192, 977725, 977727, 977732, 977746, 977752, 977754, 977771, 977778, 977782, 977784, 977805, 977809, 977824, 977826, 977827, 977850, 977907, 977908, 977932, 977933, 977936, 977939, 977940, 977943, 977944, 977945, 977946, 977954, 977958, 978020, 978028, 978396, 978402, 978410, 978419, 978420, 978428, 978434, 978437, 978445, 978446, 978448, 978454, 978458, 978462, 978465, 978471, 978472, 978474, 978486, 978492, 978506, 978553, 978570, 978578, 978580, 978586, 978600, 978601, 978616, 978623, 978628, 978689, 978694, 978695, 978696, 978708, 978712, 978716, 978718, 978964, 978966, 978967, 978970, 978977, 978978, 979023, 979024, 979025, 979029, 979034, 979035, 979047, 979048, 979050, 979101, 979107, 979401, 979409, 979418, 979524, 979529, 979533, 979603, 979611, 979619, 979697, 979709, 979739, 979744, 979748, 979749, 979751, 979756, 979757, 979766, 979771, 979775, 979777, 979778, 979780, 979804, 979805, 979807, 979810, 979815, 979839, 979857, 979865, 979868, 979873, 979881, 980113, 980115, 980116, 980117, 980123, 980126, 980129, 980559, 980577, 980675, 980702, 980868, 980872, 981344, 981423, 981424, 981491, 981837, 981840, 981906, 981972, 981983, 981988, 982610, 982863, 983662, 983999, 984030, 984044.

Cardiovascular Devices

3

Yes

nationwide within US only (OUS distribution not affected).

Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, Models N118 and N119. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 66112-5798, USA. The product is indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support. COGNIS devices also provide bi-ventricular pacing.

Model H220, serial numbers: 511302, 512322, 513553, 513555, 513592, 513617, 513637, 513638, 513641, 513653, 513741, 513876, 513883, 513886, 513888, 513906, 513940, 513951, 513954, 513988, 514010, 514029, 514033, 514041, 514044, 514047, 514060, 514065, 514070, 514080, 514105, 514107, 514121, 514129.  Model H225, serial numbers: 562014, 562031, 562033, 562040, 562067, 562080, 562116, 562124, 562129, 562133.  Model H227, serial numbers: 511024, 561060, 561618, 562179, 562439, 562789, 563298, 563319, 563323, 563342, 563350, 563366, 563391, 563395, 563400, 563411, 563470, 563484, 563532, 563535, 563547, 563589, 563608, 563615, 563616, 563624, 563662, 563714, 563771, 563785, 563799, 563801, 563804, 563820, 563823, 563824, 563825, 563829, 563831, 563832, 563833, 563840, 563845, 563846, 563847, 563852, 563853, 563854, 563855, 563908, 563918, 563934, 563957, 563962, 563967, 563970, 563972, 563976.  Model H229, serial numbers: 560803, 560813, 560837, 560872, 560873, 560891, 560918, 560921, 560946, 560958, 560959, 560968, 560978, 560985, 561002, 561006, 561021, 561023, 561028, 561030, 561036, 561040, 561057, 561061, 561069, 561073, 561077, 561080, 561092, 561095, 561155, 561158, 561160.

Cardiovascular Devices

3

Yes

nationwide within US only (OUS distribution not affected).

Boston Scientific LIVIAN Cardiac Resynchronization Therapy Defibrillator (CRT-D), models H220, H225, H227, H229. The LIVIAN family of cardiac resynchronization therapy defibrillators (CRT-Ds), provide ventricular tachyarrhythmia and cardiac resynchronization therapies. Ventricular tachyarrhythmia therapy is for the treatment of ventricular tachycardia (VT) and ventricular fibrillation (VF), rhythms that are associated with sudden cardiac death (SCD). Cardiac resynchronization therapy is for the treatment of heart failure(HF) and uses biventricular electrical stimulation to synchronize ventricular contractions. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue, St. Paul, MN 55112-5798 USA.