Nellcor

  • Model / Serial
    All units with serial numbers beginning with G01844386.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    There are 2,950 Direct US and US territory Customers. Product shave also been distributed to Canada, Europe, Japan, Latin America and Australia.
  • Product Description
    Nellcor brand Pulse Oximeter, model N-395, || Made in Ireland; Distributed by Tyco Healthcare Group, LP, Nellcor Puritan Bennett, Inc., Pleasanton, CA 94588 U.S.A.
  • Manufacturer
  • 3 Events

Manufacturer

  • Manufacturer Address
    Nellcor Puritan Bennett, 4280 Hacienda Dr, Pleasanton CA 94588-2719
  • Source
    USFDA

37 devices with a similar name

Learn more about the data here

  • Model / Serial
  • Product Description
    medical_device
  • Manufacturer
  • Model / Serial
    Lot Numbers: 161510095H, 161620089H, 161690203H, 161760132H, 161900091H,161970090H, 162040107H, 162110103H, 162320191H, 162390212H
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide. Foreign: Belgium Germany France Netherlands
  • Product Description
    Covidien Nellcor SpO2 Forehead Sensor || Item Code: RS10; || The Covidien Nellcor¿ Forehead SpO2Sensor, model RS10, is indicated for use when continuous non-invasive arterial oxygen saturation and pulse rate monitoring are required for patients weighing more than 40 kg.
  • Manufacturer
  • Model / Serial
    All lots of the CapnoProbe are under recall. Each unit has a code number printed on the packaging.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The firm has distributed the sensors to 1 researcher in Europe, and 68 to direct customers (medical facilities) and 112 Field Sales Reps. Currently, there are no finished goods at the manufacturing site. 655 cases of product were disposed of at the distribution facility due to product expiration. The firm estimates 442 cases (3,536 units) to be in distribution channels.
  • Product Description
    The probes involved have been part of the Nellcor¿ CapnoProbeTM SLS~1 Sublingual System. The CapnoProbe system consists of an N-80 CapnoProbe device and an SLS-1 Sublingual Sensor, or probe. Each probe is packaged in a metal canister filled with a nonsterile buffered saline solution. The canister is in a sealed foil envelope. Each disposable probe is used only one time.
  • Manufacturer
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