Vital Signs

  • Model / Serial
    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
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide and Foreign
  • Product Description
    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

Manufacturer

  • Manufacturer Address
    Vital Signs Devices, a GE Healthcare Company, 20 Campus Rd, Totowa NJ 07512-1210
  • Manufacturer Parent Company (2017)
  • Source
    USFDA

137 devices with a similar name

Learn more about the data here

  • Model / Serial
    DX2020
  • Product Description
    Indicated as a monitor of high-capacity physiological parameters for patients who need high degree of monitoring. Indicated to monitor physiological parameters for use in situations such as critical or anesthetic care (adult, pediatric, neonatal).
  • Manufacturer
  • Model / Serial
    ULTRAVIEW SL 91496 with command modules with option A, B, C, I ", lots 128280, 129940, 129420 and 155640.
  • Product Description
    Indicated for monitoring vital signs in patients in critical condition or observation. Use in hospital units (uci, surgery, emergencies, etc.) and ambulances.
  • Manufacturer
  • Model / Serial
  • Product Description
    Used in the surveillance of patients through vital physiological parameters.
  • Manufacturer
  • Model / Serial
    Model: VSI-1016 and VSI 1016EU, Affected: All product labelled "Made in Costa Rica"
  • Manufacturer
  • Model / Serial
    Model: Catalogue: 3010556, Affected: All serial numbers
  • Manufacturer
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