Ventilator

  • Modelo / Serial
    Model Number: HT70 and HT70 Plus.  Serial numbers: N12HT700514226 to N12HT700514231, N12HT700514233 to N12HT700514236, N12HT700514238 to N12HT700614280, N12HT700614282 to N12HT700614299, N12HT700614301 to N12HT700614309, N12HT720410266 to N12HT720410268, N12HT720410271, N12HT720410273, N12HT720410282, N12HT720410283, N12HT720410286, N12HT720410288, N12HT720410289, N12HT720410290, N12HT720410294 to N12HT720510300, N12HT720510302, N12HT720510322 to N12HT720510330, N12HT720510332 to N12HT720510344.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution: USA (nationwide) and countries of: Brazil, Chile, Egypt, France, Hong Kong, India, Japan, Norway, Philippines and South Africa.
  • Descripción del producto
    Newport HT70 and HT70 Plus Ventilators, Model Number: HT70 and HT70 Plus. || Product Usage: || The HT70 ventilator system is intended to provide continuous or intermittent positive pressure mechanical ventilatory support for the care of individuals who require mechanical ventilation through invasive or non-invasive interfaces. Specifically, the HT70 family of ventilators is applicable for infant, pediatric and adult patients greater than or equal to 5 kg (11 lbs.). The HT70 is a restricted medical device intended for use by qualified, trained personnel under the direction of a physician. The HT70 is suitable for use in hospital, sub-acute, emergency room, and home care environments, as well as for transport and emergency response applications.
  • Manufacturer
  • 1 Event

Fabricante

  • Dirección del fabricante
    Newport Medical Instruments Inc, 1620 Sunflower Ave, Costa Mesa CA 92626-1513
  • Empresa matriz del fabricante (2017)
  • Comentario del fabricante
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    USFDA

745 dispositivos con un nombre similar

Más información acerca de la data acá

  • Modelo / Serial
    A01916, A01961, A02196, A02656, A02985, A03667, A03696, A03741, A03774, A03809, A04262, A05454, A06194, A06585-A06598, A06600-A06613, A06615, A06616, A06618-A06620, A06622-A06624, A06626-A06630, A06633, A06635-A06637, A06639-A06654, A06656-A06659, A06661-A06670, A06672-A06684, A06686-A06696, A06698-A06700, A06702-A06707, A06709, A06710, A06712-A06716, A06734, A06746-A06748, A06750, A06755-A06758, A06760-A06763, A06765-A06766, A06769, A06771, A06779-A06780, A06783-A06785 and A07226.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Within the US to AK, AZ, CA, CO, FL, GA, ID, IL, IN, LA, MI, MO, NE, NJ, NY, NV, OH, OK, OR, PA, SC, TX, UT, VA and WI. OUS to include: Belgium, Brazil, Canada, India, Italy, Korea and United Kingdom
  • Descripción del producto
    Lap Top Ventilator (LTV) Series continuous ventilator, model LTV-1000. The LTV1000 ventilator is intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. The LTV-1000 is a prescription medical device suitable for use in institutional, home and transport settings.
  • Manufacturer
  • Modelo / Serial
    C01063, C01112, C01605, C02231, C02247, C02488, C03055, C03096, C03123, C03137, C03437, C03492, C03828, C03861, C03884, C04056, C04580, C05336, C06640, C07105-C07107, C07109-C07113, C07115, C07116, C07118, C07122-C07126, C07130, C07141, C07145, C07152, C07154, C07157-C07160, C07162, C07168, C07170, C07173, C07188, C07194 and C07195
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Within the US to AK, AZ, CA, CO, FL, GA, ID, IL, IN, LA, MI, MO, NE, NJ, NY, NV, OH, OK, OR, PA, SC, TX, UT, VA and WI. OUS to include: Belgium, Brazil, Canada, India, Italy, Korea and United Kingdom
  • Descripción del producto
    Lap Top Ventilator (LTV) Series continuous ventilator, model LTV-950. The LTV-950 ventilator is intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. The LTV-950 is a prescription medical device suitable for use in institutional, home and transport settings.
  • Manufacturer
  • Modelo / Serial
    B01117, B01236, B01483, B01637, B01640, B01655, B01802, B01816, B01954, B01974, B01997, B03500-B03524, B03526-B03536
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Within the US to AK, AZ, CA, CO, FL, GA, ID, IL, IN, LA, MI, MO, NE, NJ, NY, NV, OH, OK, OR, PA, SC, TX, UT, VA and WI. OUS to include: Belgium, Brazil, Canada, India, Italy, Korea and United Kingdom
  • Descripción del producto
    Lap Top Ventilator (LTV) Series continuous ventilator, model LTV-900. The LTV-900 ventilator is intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. The LTV-900 is a prescription medical device suitable for use in institutional, home and transport settings.
  • Manufacturer
  • Modelo / Serial
    Affected lots for all catalogue numbers: 041101-050331(inclusive).
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide in AR, CA, FL, IL, LA, MN, NC, OH, SD, TX, UT, & VA. International distribution
  • Descripción del producto
    Fisher & Paykel Healthcare Adult Respiratory Ventilator Circuit-Dual Heated Catalogue Number RT210
  • Manufacturer
  • Modelo / Serial
    Affected lots for all catalogue numbers: 041101-050331(inclusive).
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide in AR, CA, FL, IL, LA, MN, NC, OH, SD, TX, UT, & VA. International distribution
  • Descripción del producto
    Fisher & Paykel Healthcare Adult Respiratory Ventilator Circuit-Dual Heated Catalogue Number RT211
  • Manufacturer
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