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  • Dispositivo 153
  • Fabricante 42
  • Evento 124969
  • Implante 0
Portable patient monitor with arrhythmia detection or alarms.
  • Modelo / Serial
    SERIAL NUMBERS: 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 1367-000112, 1367-000113, 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  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA (nationwide) and the countries of: International distribution to: Canada, China, France, Germany, Italy, and the United Kingdom.
  • Descripción del producto
    Product is the Ultraview Spacelabs Compact monitor, models 91367, 91369, and 91370, with touch screen display and wireless option. || Product Usage: Spacelabs Medical PCIS patient monitors passively display data generated from Spacelabs Medical patient parameter modules, Flexport interfaces, gas analyzers, and other SDLC based products. Spacelabs Medical PCIS patient monitors may also function as a generic display or computer terminal. As a generic display or terminal, the PCIS patient monitors allow network based applications to open windows and display information on other networked monitors. PCIS patient monitors is intended to sound various alarm tones that are generated by the specific PCIS patient parameter modules. Each patient parameter module determines (a) when an alarm condition is violated; (b) the alarm priority (i.e. high, medium or low); (c) alarm limits; and (d) when to generate and terminate alarms. PCIS patient monitors are also capable of displaying alarm conditions on other monitors that are on the network through the Alarm Watch feature. Spacelabs Medical PCIS patient monitors are designed to communicate with a variety of external devices such as display devices, network devices, serial devices, user input devices, audio system, local/remote recorders and Spacelabs Medical patient parameter modules. In all applications, Spacelabs Medical PCIS patient monitors provide access to that data on the Spacelabs Medical network either via hardwired or wireless transmission.. Through this network, a patients data may be displayed at the bedside monitor, central station or a clinical information system.
  • Manufacturer
    Spacelabs Healthcare, Llc
  • 1 Event
    • Retiro De Equipo (Recall) de Portable patient monitor with arrhythmia detection or alarms.
Vital Signs Monitor, Model 93300
  • Modelo / Serial
    Model 93300. Serial numbers: 3300-000001, 3300-000002, 3300-000003, 3300-000005, 3300-000006, 3300-000007, 3300-000008, 3300-000009, 3300-000010, 3300-000011, 3300-000012, 3300-000013, 3300-000014, 3300-000015, 3300-000016, 3300-000017, 3300-000018, 3300-000019, 3300-000020, 3300-000021, 3300-000022, 3300-000023, 3300-000024, 3300-000026, 3300-000027, 3300-000028, 3300-000029, 3300-000030, 3300-000031, 3300-000032, 3300-000033, 3300-000034, 3300-000035, 3300-000036, 3300-000037, 3300-000038, 3300-000039, 3300-000040, 3300-000041, 3300-000042, 3300-000043, 3300-000044, 3300-000045, 3300-000046, 3300-000047, 3300-000049, 3300-000050, 3300-000052, 3300-000053, 3300-000054, 3300-000055, 3300-000056, 3300-000057, 3300-000058, 3300-000059, 3300-000060, 3300-000061, 3300-000062, 3300-000063, 3300-000064, 3300-000065, 3300-000066, 3300-000067, 3300-000068, 3300-000069, 3300-000070, 3300-000071, 3300-000072, 3300-000073, 3300-000074, 3300-000075, 3300-000076, 3300-000077, 3300-000078, 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3300-001811, 3300-001812, 3300-001813, 3300-001814, 3300-001815, 3300-001816, 3300-001817, 3300-001818, 3300-001819, 3300-001820, 3300-001821, 3300-001822, 3300-001823, 3300-001824, 3300-001825, 3300-001826, 3300-001827, 3300-001828, 3300-001829, 3300-001830, 3300-001831, 3300-001832, 3300-001833, 3300-001834, 3300-001835, 3300-001836, 3300-001837, 3300-001838, 3300-001839, 3300-001840, 3300-001841, 3300-001842, 3300-001843, 3300-001844, 3300-001845, 3300-001846, 3300-001847, 3300-001848, 3300-001849, 3300-001850, 3300-001851, 3300-001852, 3300-001853, 3300-001854, 3300-001855, 3300-001856, 3300-001857, 3300-001858, 3300-001859, 3300-001860, 3300-001861, 3300-001862, 3300-001863, 3300-001864, 3300-001865, 3300-001866, 3300-001867, 3300-001868, 3300-001869, 3300-001870, 3300-001871, 3300-001872, 3300-001873, 3300-001874, 3300-001875, 3300-001876, 3300-001877, 3300-001878, 3300-001879, 3300-001880, 3300-001881, 3300-001882, 3300-001883, 3300-001884, 3300-001885, 3300-001886, 3300-001887, 3300-001888, 3300-001889, 3300-001890, 3300-001891, 3300-001892, 3300-001893, 3300-001894, 3300-001895, 3300-001896, 3300-001897, 3300-001898, 3300-001899, 3300-001900, 3300-001901, 3300-001902, 3300-001903, 3300-001904, 3300-001905, 3300-001906, 3300-001907, 3300-001908, 3300-001909, 3300-001910, 3300-001911, 3300-001912, 3300-001913, 3300-001914, 3300-001915, 3300-001916, 3300-001917, 3300-001918, 3300-001919, 3300-001920, 3300-001921, 3300-001922, 3300-001923, 3300-001924, 3300-001925, 3300-001926, 3300-001927, 3300-001928, 3300-001929, 3300-001930, 3300-001931, 3300-001932, 3300-001933, 3300-001934, 3300-001935, 3300-001936, 3300-001937, 3300-001938, 3300-001939, 3300-001940, 3300-001941, 3300-001942, 3300-001943, 3300-001944, 3300-001945, 3300-001946, 3300-001947, 3300-001948, 3300-001949, 3300-001950, 3300-001951, 3300-001951, 3300-001952, 3300-001953, 3300-001954, 3300-001955, 3300-001956, 3300-001957, 3300-001958, 3300-001959, 3300-001960, 3300-001961, 3300-001962, 3300-001963, 3300-001964, 3300-001965, 3300-001966, 3300-001967, 3300-001968, 3300-001969, 3300-001970, 3300-001971, 3300-001972, 3300-001973, 3300-001974, 3300-001975, 3300-001976, 3300-001977, 3300-001978, 3300-001979, 3300-001980, 3300-001981, 3300-001982, 3300-001983, 3300-001984, 3300-001985, 3300-001986, 3300-001987, 3300-001988, 3300-001989, 3300-001990, 3300-001991, 3300-001992, 3300-001993, 3300-001994, 3300-001995, 3300-001996, 3300-001997, 3300-001998, 3300-001999, 3300-002000, 3300-002001, 3300-002002, 3300-002003, 3300-002004, 3300-002005, 3300-002006, 3300-002007, 3300-002008, 3300-002009, 3300-002010, 3300-002011, 3300-002012, 3300-002013, 3300-002014, 3300-002015, 3300-002016, 3300-002017, 3300-002018, 3300-002019, 3300-002020, 3300-002021, 3300-002022, 3300-002023, 3300-002024, 3300-002025, 3300-002026, 3300-002027, 3300-002028, 3300-002029, 3300-002030, 3300-002031, 3300-002032, 3300-002033, 3300-002034, 3300-002035, 3300-002036, 3300-002037, 3300-002038, 3300-002039, 3300-002040, 3300-002041, 3300-002042, 3300-002043, 3300-002044, 3300-002045, 3300-002046, 3300-002047, 3300-002048, 3300-002049, 3300-002050, 3300-002051, 3300-002052, 3300-002053, 3300-002054, 3300-002055, 3300-002056, 3300-002057, 3300-002058, 3300-002059, 3300-002060, 3300-002062, 3300-002063, 3300-002064, 3300-002065, 3300-002066, 3300-002067, 3300-002068, 3300-002069, 3300-002070, 3300-002071, 3300-002072, 3300-002076, 3300-002077, 3300-002078, 3300-002079, 3300-002080, 3300-002081, 3300-002082, 3300-002083, 3300-002084, 3300-002085, 3300-002086, 3300-002087, 3300-002088, 3300-002089, 3300-002090, 3300-002091, 3300-002092, 3300-002093, 3300-002094, 3300-002095, 3300-002096, 3300-002097, 3300-002098, 3300-002099, 3300-002100, 3300-002101, 3300-002102, 3300-002103, 3300-002104, 3300-002105, 3300-002106, 3300-002107, 3300-002108, 3300-002109, 3300-002110, 3300-002111, 3300-002112, 3300-002113, 3300-002114, 3300-002115, 3300-002116, 3300-002117, 3300-002118, 3300-002119, 3300-002120, 3300-002121, 3300-002122, 3300-002123, 3300-002124, 3300-002125, 3300-002126, 3300-002127, 3300-002128, 3300-002129, 3300-002130, 3300-002131, 3300-002132, 3300-002133, 3300-002134, 3300-002135, 3300-002136, 3300-002137, 3300-002138, 3300-002139, 3300-002140, 3300-002141, 3300-002142, 3300-002143, 3300-002144, 3300-002145, 3300-002146, 3300-002147, 3300-002148, 3300-002149, 3300-002150, 3300-002151, 3300-002152, 3300-002153, 3300-002154, 3300-002155, 3300-002156, 3300-002157, 3300-002158, 3300-002159, 3300-002160, 3300-002161, 3300-002162, 3300-002163, 3300-002164, 3300-002165, 3300-002166, 3300-002167, 3300-002168, 3300-002169, 3300-002170, 3300-002171, 3300-002172, 3300-002173, 3300-002174, 3300-002175, 3300-002176, 3300-002177, 3300-002178, 3300-002179, 3300-002180, 3300-002181, 3300-002182, 3300-002183, 3300-002184, 3300-002185, 3300-002186, 3300-002187, 3300-002188, 3300-002190, 3300-002191, 3300-002192, 3300-002193, 3300-002194, 3300-002195, 3300-002196, 3300-002197, 3300-002198, 3300-002199, 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3300-100048, 3300-100051, 3300-100052, 3300-100055, 3300-100056, 3300-100057, 3300-100058, 3300-100059, 3300-100060, 3300-100061, 3300-100066, 3300-100069, 3300-100071, 3300-100072, 3300-100078, 3300-100079, 3300-100082, 3300-100083, 3300-100086, 3300-100087, 3300-100088, 3300-100089, 3300-100091, 3300-100093, 3300-100094, 3300-100095, 3300-100101, 3300-100102, 3300-100103, 3300-100106, 3300-100119, 3300-100126, 3300-100134, 3300-100135, 3300-100136, 3300-100137, 3300-100138, 3300-100139, 3300-100140, 3300-100141, 3300-100142, 3300-100143, 3300-100144, 3300-100145, 3300-100146, 3300-100147, 3300-100148, 3300-100149, 3300-100150, 3300-100151, 3300-100152, 3300-100153, 3300-100154, 3300-100155, 3300-100156, 3300-100157, 3300-100158, 3300-100159, 3300-100160, 3300-100161, 3300-100162, 3300-100163, 3300-100164, 3300-100165, 3300-100166, 3300-100167, 3300-100168, 3300-100169, 3300-100170, 3300-100171, 3300-100174, 3300-100175, 3300-100176, 3300-100178, 3300-100179, 3300-100180, 3300-100181, 3300-100182, 3300-100183, 3300-100184, 3300-100185, 3300-100186, 3300-100187, 3300-100188, 3300-100196, 3300-100197, 3300-100198, 3300-100199, 3300-100200, 3300-100201, 3300-100202, 3300-100203, 3300-100204, 3300-100205, 3300-100206, 3300-100207, 3300-100208, 3300-100209, 3300-100210, 3300-100211, 3300-100212, 3300-100213, 3300-100214, 3300-100215, 3300-100216, 3300-100217, 3300-100218, 3300-100219, 3300-100220, 3300-100221, 3300-100222, 3300-100223, 3300-100224, 3300-100225, 3300-100226, 3300-100227, 3300-100228, 3300-100229, 3300-100230, 3300-100231, 3300-100232, 3300-100233, 3300-100234, 3300-100235, 3300-100236, 3300-100237, 3300-100238, 3300-100239, 3300-100240, 3300-100241, 3300-100242, 3300-100243, 3300-100244, 3300-100245, 3300-100246, 3300-100247, 3300-100248, 3300-100249, 3300-100250, 3300-100251, 3300-100252, 3300-100253, 3300-100254, 3300-100255, 3300-100256, 3300-100260, 3300-100261, 3300-100262, 3300-100264, 3300-100266, 3300-100267, 3300-100268, 3300-100269, 3300-100270, 3300-100273, 3300-100274, 3300-100275, 3300-100276, 3300-100277, 3300-100278, 3300-100279, 3300-100280, 3300-100281, 3300-100282, 3300-100283, 3300-100284, 3300-100285, 3300-100286, 3300-100287, 3300-100288, 3300-100289, 3300-100290, 3300-100291, 3300-100292, 3300-100293, 3300-100294, 3300-100295, 3300-100296, 3300-100297, 3300-100298, 3300-100299, 3300-100300, 3300-100301, 3300-100303, 3300-100304, 3300-100305, 3300-100306, 3300-100307, 3300-100308, 3300-100309, 3300-100310, 3300-100311, 3300-100312, 3300-100313, 3300-100314, 3300-100315, 3300-100316, 3300-100317, 3300-100318, 3300-100319, 3300-100320, 3300-100321, 3300-100322, 3300-100323, 3300-100324, 3300-100325, 3300-100326, 3300-100327, 3300-100328, 3300-100330, 3300-100336, 3300-100337, 3300-100341, 3300-100363, 3300-100364, 3300-100365, 3300-100366, 3300-100368, 3300-100369, 93300-100006, 93300-100007, 93300-100009, 93300-100010, 93300-100013, 93300-100014, 93300-100016, 93300-100020, 93300-100036, 93300-100038, 93300-100040, 93300-100046, 93300-100047, 93300-100049, 93300-100050, 93300-100053, 93300-100054, 93300-100062, 93300-100063, 93300-100064, 93300-100067, 93300-100068, 93300-100070, 93300-100073, 93300-100074, 93300-100075, 93300-100076, 93300-100077, 93300-100080, 93300-100081, 93300-100084, 93300-100085, 93300-100090, 93300-100092, 93300-100096, 93300-100097, 93300-100100, 93300-100104, 93300-100105, 93300-100106, 93300-100107, 93300-100108, 93300-100109, 93300-100110, 93300-100111, 93300-100112, 93300-100113, 93300-100114, 93300-100115, 93300-100116, 93300-100117, 93300-100118, 93300-100120, 93300-100121, 93300-100122, 93300-100123, 93300-100124, 93300-100125, 93300-100126, 93300-100127, 93300-100128, 93300-100129, 93300-100130, 93300-100131, 93300-100132, 93300-100133, 93300-100258, 93300-100259, 93300-100263, AND 93300-100265.
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution-USA (Puerto Rico) and countries of ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, BAHRAIN, BANGLADESH, BELGIUM, BOLIVIA, CHILE, CHINA, COLOMBIA, CYPRUS, CZECH REPUBLIC, DOMINICAN REPUBLIC, ECUADOR, EGYPT, EL SALVADOR, FRANCE, GERMANY, GREECE, GUATEMALA, HONDURAS, HONG KONG, INDIA, INDONESIA, IRAQ, ISRAEL, ITALY, KENYA, KOREA, REPUBLIC OF, KUWAIT, LEBANON, MACEDONIA, MALAYSIA, NEPAL, NETHERLANDS, NICARAGUA, OMAN, PALESTINE, PANAMA, PARAGUAY, PERU, PUERTO RICO, PHILIPPINES, QATAR, ROMANIA, SAUDI ARABIA, SINGAPORE, SOUTH AFRICA, SPAIN, SRI LANKA, SWITZERLAND, SYRIAN ARAB REPUBLIC, THAILAND, TRINIDAD AND TOBAGO, TUNISIA, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, VENEZUELA, and VIET NAM.
  • Descripción del producto
    Spacelabs Medical elance Vital Signs Monitor, Model 93300. || The Spacelabs elance Vital Signs Monitor and elance Central Station is a prescription device intended for use by healthcare professionals in all areas of a healthcare facility. It is indicated for use in adult and pediatric populations. The device facilitates the monitoring of: ECG with arrhythmia detection; respiration; non-invasive blood pressures; invasive blood pressures; body temperature; functional arterial oxygen saturation; and entidal CO2.
  • Manufacturer
    Spacelabs Healthcare, Llc
  • 1 Event
    • Retiro De Equipo (Recall) de Vital Signs Monitor, Model 93300
Spacelabs Healthcare HookUp kits
  • Modelo / Serial
    B339 is listed on the PDI Alcohol Prep Pads.  Hook-up kits that contain the affected alcohol prep pads are as follows:  Aria, Kit Part number 23189-010, Kit, Basic hookup, AA; CardioCall, Kit Part number 23189-020, Kit, Hookup, CardioCall; Aria, Kit Part number 23189-106, Kit, Aria Hookup; Aria, Kit Part number 23189-110, Kit, Aria Hookup; Flashcorder, Kit Part number 23189-111, Kit, Flashcorder Hookup; Aria, Kit Part number 23189-113, Holter Hookup Kit 7 electrode; LifeCard 12, Kit Part number 23189-114, Kit, Hookup, LC12, Multilingual; Aria, Kit Part number 23189-115, Kit, Basic Hookup, AAA; LifeCard, Kit Part number 23189-116, Kit, Holter Hookup, LifeCard; 483, Kit Part number 23189-117, Kit, Holter Hookup 483; Aria, Kit Part number 23189-153, Holter Hookup Kit, 7 electrode; Aria VLC, Kit Part number 23189-207, Kit, Aria Hookup, VLC; EVO, Kit Part number 50-0048, 4 electrode hookup kit without pouch; EVO, Kit Part number 50-0049, 4 electrode hookup kit with pouch; EVO, Kit Part number SK10456, Sample Kit, Disposables.
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA (natiowide) and the countries of South Africa, Turkey, Bangladesh, Dominican Republic, Peru, Belgium, Ecuador, Romania, Austria, Honduras, Guatemala, Denmark, Republic of Korea, Argentina, Thailand, Italy, Austria, Chile, Bolivia, Mexico, Sweden, Netherlands, Switzerland, India, Serbia, Australia, Morocco, Turkey, ISpain, Czech Republic, Slovakia, Poland, China, Columbia, Portugal, Canada, Germany, United Kingdom, Singapore, France, Russian Federation, Bahrain, and Kuwait
  • Descripción del producto
    PDI Electrode Prep Pads, Skin Prep B339 are non-sterile alcohol prep pads. They are included in the Spacelabs Healthcare Hook-Up kits. Each kit contains 2-4 pieces of PDI Electrode Prep Pads . || Hook-up kits that contain the affected alcohol prep pads are as follows: || Aria, Kit Part number 23189-010, Kit, Basic hookup, AA; || CardioCall, Kit Part number 23189-020, Kit, Hookup, CardioCall; || Aria, Kit Part number 23189-106, Kit, Aria Hookup; || Aria, Kit Part number 23189-110, Kit, Aria Hookup; || Flashcorder, Kit Part number 23189-111, Kit, Flashcorder Hookup; || Aria, Kit Part number 23189-113, Holter Hookup Kit 7 electrode; || LifeCard 12, Kit Part number 23189-114, Kit, Hookup, LC12, Multilingual; || Aria, Kit Part number 23189-115, Kit, Basic Hookup, AAA; || LifeCard, Kit Part number 23189-116, Kit, Holter Hookup, LifeCard; || 483, Kit Part number 23189-117, Kit, Holter Hookup 483; || Aria, Kit Part number 23189-153, Holter Hookup Kit, 7 electrode; || Aria VLC, Kit Part number 23189-207, Kit, Aria Hookup, VLC; || EVO, Kit Part number 50-0048, 4 electrode hookup kit without pouch; || EVO, Kit Part number 50-0049, 4 electrode hookup kit with pouch; || EVO, Kit Part number SK10456, Sample Kit, Disposables. || A surgical skin degreaser or an adhesive tape solvent is a device that consists of a liquid such as 1,1,2-trichloro-1,2,2-trifluoroethane; 1,1,1-trichloroethane; and 1,1,1-trichloroethane with mineral spirits intended to be used to dissolve surface skin oil or adhesive tape.
  • Manufacturer
    Del Mar Reynolds Medical, Ltd.
  • 1 Event
    • Retiro De Equipo (Recall) de Spacelabs Healthcare HookUp kits
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Aviso

Los dispositivos médicos ayudan con el diagnóstico, la prevención y el tratamiento de muchas lesiones y enfermedades. A través de la International Medical Devices Database no estamos sugiriendo que compañías u otras entidades mencionadas en la base de datos hayan sido parte de una conducta ilegal o hayan actuado de manera impropia. Un mismo dispositivo médico puede tener distintos nombres en diferentes países. Esta base de datos no busca proporcionar asesoría médica. Los pacientes deben consultar con sus médicos para determinar si la data contiene información relevante y si la misma tiene implicaciones médicas para ellos.

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