Devices

Device Recall SureT Infusion SetThe Contact Detach Infusion Set

  • Modelo / Serial
    5038783, 5040464, 5042582, 5042584, 5043414, 5043415, 5046638, 5046639, 5047168, 5049122, 5052903, 5052904, 5056680, 5057219, 5057241, 5057953, 5060205, 5061496, 5063694, 5064402, 5068516, 5068555, 5071403, 5072333, 5073682, 5075554, 5076349, 5043121, 5044843, 5057215, 5064141, 5068515, 5035649, 5035690, 5039578, 5039579, 5039580, 5039581, 5040158, 5040159, 5040465, 5040466, 5040467, 5040468, 5042578, 5042580, 5042581, 5043094, 5043095, 5043100, 5043106, 5043387, 5043417, 5043418, 5043419, 5046393, 5046395, 5046396, 5046640, 5046641, 5047170, 5047171, 5047510, 5047511, 5047580, 5047581, 5047582, 5049123, 5050034, 5050035, 5050036, 5051560, 5051561, 5051562, 5052905, 5052906, 5053786, 5053787, 5053788, 5054558, 5054559, 5055496, 5055497, 5056681, 5056682, 5057047, 5057221, 5057226, 5057231, 5057232, 5057242, 5057243, 5057251, 5057954, 5057955, 5060206, 5060207, 5060208, 5060946, 5060947, 5060948, 5060949, 5060988, 5060989, 5063695, 5063696, 5064142, 5064143, 5064144, 5064145, 5065089, 5065090, 5065106, 5066445, 5066513, 5066514, 5066524, 5067182, 5067183, 5067587, 5067589, 5067590, 5068518, 5068520, 5068522, 5070664, 5072716, 5072717, 5075402, 5075403, 5075555, 5075556, 5075557, 5076350, 5077461, 5077462, 5078949, 5053658, 5064299, 5032640, 5039582, 5039589, 5040469, 5041195, 5043329, 5043420, 5043421, 5046397, 5047172, 5047175, 5047583, 5049124, 5050037, 5051563, 5052907, 5053661, 5056683, 5057244, 5058702, 5058704, 5059523, 5059551, 5059552, 5060209, 5060950, 5061497, 5063697, 5064403, 5066515, 5067184, 5067592, 5068528, 5071405, 5072347, 5072718, 5075404, 5075558, 5077463, 5038779, 5032646, 5040470, 5040471, 5041196, 5043112, 5043114, 5043422, 5043423, 5044841, 5047177, 5047584, 5050038, 5051564, 5052908, 5055463, 5055465, 5056684, 5057245, 5060210, 5060951, 5060952, 5060990, 5067185, 5067593, 5068526, 5070666, 5071406, 5072719, 5075405, 5077464, 5078950, 5057216, 5032652, 5040472, 5040473, 5043117, 5043425, 5043426, 5043427, 5046644, 5046645, 5047179, 5049125, 5053789, 5055498, 5058706, 5058708, 5059553, 5060953, 5060991, 5066516, 5068531, 5070667, 5071407, 5072631, 5076348, 5076353, 5077465, 5039586, 5040474, 5072633, 5079671, 5038787, 5043124, 5043428, 5043429, 5053790, 5064146, 5064404, 5068530, 5068557, 5072634
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US including CA, IN, PA, and Internationally to Canada, Korea, and Japan.
  • Descripción del producto
    SureT G29 6mm, 18", Paradigm; SureT G29 6mm 23"; SureT G29 6mm, 23", Paradigm; SureT G29 6mm 32"' SureT G29 6mm, 32", Paradigm; SureT G29 8mm, 23"; SureT G29 8mm, 23", Paradigm; SureT G29 8mm, 32"; SureT G29 8mm, 32", Paradigm; SureT G29 10mm, 32", Paradigm || The products are used in combination with insulin infusion pumps for continuous subcutaneous infusion of insulin
  • Manufacturer
    Unomedical As
  • 1 Event

Fabricante

Unomedical As
  • Dirección del fabricante
    Unomedical As, Aholmvej 1 3 Osted, Roskilde Denmark
  • Empresa matriz del fabricante (2017)
    Triona Holding Sa
  • Source
    USFDA

Dispositivo con un nombre similar

Más información acerca de la data acá

Device Recall SureT infusion setThe Contact Detach infusion set
  • Modelo / Serial
    5031810, 5034061, 5034232, 5035097, 5036348, 5038182, 5038183, 5038184, 5038185, 5038186, 5038187, 5038188, 5040990, 5040991, 5040992, 5041073, 5041074, 5045147, 5045148, 5047241, 5047242, 5047243, 5047245, 5048097, 5053689, 5054465, 5054466, 5054550, 5054553, 5054554, 5057103, 5057104, 5057105, 5057106, 5058633, 5058637, 5058731, 5058732, 5058733, 5058734, 5062769, 5062770, 5062780, 5062811, 5062812, 5062813, 5066512, 5066999, 5067219, 5067220, 5067221, 5067222, 5067223, 5067224, 5067225, 5067226, 5067574, 5068464, 5068465, 5071889, 5073670, 5073671, 5075505, 5075509, 5076078, 5054475, 5054476, 5054477, 5054478, 5063762, 5063763
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US including CA, IN, PA, and Internationally to Canada, Korea, and Japan.
  • Descripción del producto
    Contact Detach, 8mm, 23", G29; Contact Detach 8 mm, 43", G29; Contact Detach, 6mm, 23" G29; Infusion Set, Contact Detach, 6mm x 23"; Infusion Set, Contact Detach, 6mm x 32"; Infusion Set, Contact Detach, 8mm x 23"; Infusion Set, Contact Detach, 8mm x 32" || The products are used in combination with insulin infusion pumps for continuous subcutaneous infusion of insulin
  • Manufacturer
    Unomedical As