Devices

Device Recall Mask adult, oxygen, medium concentration, elastic strap

제조사

Salter Laboratories, Division of Regulatory Affairs
  • 제조사 주소
    Salter Laboratories, Division of Regulatory Affairs, 100 Sycamore Rd, Arvin CA 93203-2300
  • Source
    USFDA

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Device Recall Mask adult, oxygen, medium concentration, elastic strap & nonbreathing
  • 모델명 / 제조번호(시리얼번호)
    Lot 030711; Product code: 8110-7-50,  Product code: 8130-7-50; Product code: E8149-7-50.
  • 의료기기 분류등급
    Anesthesiology Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution: USA (nationwide) and countries of: Belgium, Canada, Colombia and Iceland.
  • 제품 설명
    Mask adult, oxygen, medium concentration, elastic strap style w. 7' tube (Linde) 50/cs || Mask, adult, oxygen, high concentration, non-rebreathing, elastic strap style w/ 7' tube and safety vent - 50/cs; || Mask adult, oxygen, high concentration, non-rebreathing, w/7' tube w/out safety vent - 50/cs; || Salter Labs, Arvin, CA 93203 || Intended usage: respiratory therapy.
  • Manufacturer
    Salter Laboratories, Division of Regulatory Affairs