SafeSpeed Device

SafeSpeed ® device is presented in 10 units per kit, individually sterilized and packaged, with 5 different colours for easy identification in clinics; yellow, pink, green, orange and blue.

It is composed by an ultrafine capillary, attached to a 6-parts body and a movable protector. All parts are assembled with a high performance epoxy formulated to withstand the severe conditions found in cryogenic environments.

SafeSpeed ® device is CE Registed product  (Notified body 0318 Agencia Española del Medicamento) (click here). The SafeSpeed capillary is made of medical grade (USP Class VI and ISO 10993) polycarbonate and it is phalate free.

Quality Assurance tests of each kit:

  • Sterility by to meet SAL 10-6
  • 100% of the safespeed devices are tightness tested
  • Visual inspections for dimensional specifications
  • Shelf life is three years MSDS
  • Safespeed device has been designed and manufactured according to ISO 13485:2003 standard

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