Vital Signs

  • Modèle / numéro de série
    Class 1 Exempt Device No Medical Device Listing Number exp date - 13 months from the date received by the distributor.  Povidone Iodine Pads: The Povidone Iodine Pad is packaged in the Busse IV Start Kit that is included in the Intra Venous Module, which is contained in the Broselow products referenced below. Affected Armstrong product numbers: Kits: AE-4700, AE 4701, AE-4712, and PBL-PC-9A Modules: 7700RIV, 7700PIV, 7700YIV, 7700WIV, 7700BIV, 7700OIV, 7700GIV, 7730RED, 7730PUR, 7730YEL, 7730WHI, 7730BLU, 7730ORG, and 7730GRN  Affected Vital Signs product numbers: Kits: 7730ALS, 7730IALS, 7730FLY, 7730MOD Modules: 7700RIV2, 7700PIV2, 7700YIV2, 7700WIV2, 7700BIV2, 7700OIV2, 7700GIV2, 7730RED5, 7730PUR5, 7730YEL5, 7730WHI5, 7730BLU5, 7730ORG5, and 7730GRN5 Sub-Assembly: 7700RIV, 7700PIV, 7700YIV, 7700WIV, 7700BIV, 7700OIV, and 7700GIV  Lot codes of the Broselow Kits and Intra Venous Modules that contain affected Povidone Iodine Pads: 2008: 228F-366F 2009: 010K-258K and 010L-258L
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide and Foreign
  • Description du dispositif
    Broselow/Hinkle Pediatric Emergency System || Vital Signs Inc. || 20 Campus Road || Totowa, NJ 07512 USA || The system supplies you with all the information and equipment needed for a young patients' emergency resuscitation requirements, all contained in a color coded, easy-to-use kit
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Vital Signs Devices, a GE Healthcare Company, 20 Campus Rd, Totowa NJ 07512-1210
  • Société-mère du fabricant (2017)
  • Source
    USFDA

137 dispositifs médicaux avec un nom similaire

En savoir plus sur les données ici

  • Modèle / numéro de série
    863071, 863072, 863073, 863074 Affected units were shipped from January 2007 through April 2008
  • Description du dispositif
    MD: Patient monitoring system, general physiology, single-person
  • Manufacturer
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    see letter
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  • Description du dispositif
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  • Manufacturer
  • Modèle / numéro de série
    see list
  • Description du dispositif
    MD: Patient monitoring system, general physiology, multi-patient
  • Manufacturer
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