Broselow

  • 모델명 / 제조번호(시리얼번호)
    Part Number: 7730POCH. Lots: 0000993427, 0001069517
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US (Nationwide) and in the countries of Canada, Puerto Rico, United Arab Emirates, Philippines, and Europe.
  • 제품 설명
    AirLife Resuscitation, Replacement kit for outer shell, Broselow || Product Usage: || The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot adequately breathe on their own.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Vyaire Medical, 75 N Fairway Dr, Vernon Hills IL 60061-1845
  • 제조사 모회사 (2017)
  • Source
    USFDA

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  • 모델명 / 제조번호(시리얼번호)
    Lot numbers 914873, 914876, and 914878 of the individual modules (7700RAW), which are contained in Lot number 914867 of the 2/PACK (7700RAW2). Expiration Date JAN 2021.
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Illinois
  • 제품 설명
    Broselow/Hinkle, PEDIATRIC EMERGENCY SYSTEM, PINK/RED Oxygen Delivery Module 2/PACK, Product Code 7700RAW2
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Lot numbers 914873, 914876, and 914878 of the individual modules (7700RAW), which are contained in Lot number 916714 of the Broselow Complete Set of Colored Pouches, Product Code 7730MOD. Expiration Date MAR 2018.
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Illinois
  • 제품 설명
    Broselow/Hinkle, PEDIATRIC EMERGENCY SYSTEM, Broselow Complete Set of Colored Pouches, Product Code 7730MOD
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Expiration for kit is four years.   Oz Masks  #D075986 Class I Exempt Device  If you have purchased directly from Vital Signs, the product codes affected are: 7700BAW2, 7700GAW2, 7700OAW2, 7700PAW2, 7700RAW2, 7700WAW2, 7700YAW2, Kits with masks included: 7730ALS, 7730BLU5, 7730FLY, 7730GRN5, 7730IALS, 7730MOD, 7730ORG5, 7730PUR5, 7730RED5, 7730WHI5, 7730YEL5. If you have purchased directly from Armstrong Medical, the Product Codes affected are: AE-4700 AE-4712, AE-4701, 7730RED, 7730PUR, 7730YEL, 7730WHI, 7730BLU, 7730ORG, 7730GRN, 7700RAW, 7700PAW, 7700YAW, 7700WAW, 7700BAW, 7700OAW, 7700GAW " Lot numbers of the affected modules are: 2009 K109 through K365 2010 P001 through P149510 (k) : K781055; Medical Device Listing   Blood Pressure Cuffs  If you have purchased directly from Vital Signs, the product codes affected are: BP4030BR, BP4530BR, 7730POCH, 7730IALS If you have purchased directly from Armstrong Medical, the product codes affected are: AE-4703, AE- 4700, AE-4706, AE-4707 " Lot numbers affected are: For the year 2009 LOT Number 2689 through LOT Number 3659 For the year 2010 LOT Number 0010 through LOT Number 2530 Any lot number that ends in the number 1 is NOT affected by the recall.
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    IL
  • 제품 설명
    Broselow/Hinkle Pediatric Emergency System, Vital Signs Inc., 20 Campus Road, Totowa, NJ 07512 USA || The kit contains oxygen masks and blood pressure cuffs use on pediatric patients
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Part Number: 2K8080BR. Lots: 0000890354, 0000890352, 0000940373, 0000979974, 0000994500
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US (Nationwide) and in the countries of Canada, Puerto Rico, United Arab Emirates, Philippines, and Europe.
  • 제품 설명
    AirLife Resuscitation, Pediatric, with mask, 40inch oxygen reservoir tubing, pressure-relief valve, Broselow || Product Usage: || The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot adequately breathe on their own.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Part Number: 7730ALS. Lots: 0000993426, 0000994766, 0000996685, 0001011762, 0001011763, 0001017478, 0001026192, 0001026868, 0001028306, 0001031760, 0001032932, 0001048406, 0001082823
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US (Nationwide) and in the countries of Canada, Puerto Rico, United Arab Emirates, Philippines, and Europe.
  • 제품 설명
    AirLife Resuscitation, Broselow Hinkle Kit || Product Usage: || The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot adequately breathe on their own.
  • Manufacturer
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