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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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The Rondex CPR ISO-SHIELD is a mouth-to-mask barrier device used to help a rescuer avoid direct contact with the patient when doing resuscitation. Large barrier surface area, 7" X 7" (17.5 cm X 17.5 cm), maximizes isolation between rescuer and patient. The barrier material is attached to a short bite block containing TWO (2) silicone valves which helps to isolate the patient's breath from the rescuer. The bite block helps to keep the barrier positioned correctly while keeping the patient's mouth open. This makes ventilations much easier when doing the head tilt/chin lift procedure. The short bite block, 2 cm in length reduces the risk of pushing the patient's tongue back and does not require a prescription Two grips extend away from the bite block to provide a means to help the rescuer hold the small bite bloc and also help release the barrier from the patient's face between resuscitation breaths. This device is for emergency use only and should only be used by persons properly trained in CPR and in the use of this device. ISO-SHIELD (TM) of Rondex MADE IN USA
RONDEX PRODUCTS, INCORPORATED
9500 (packaged in poly bag)
In Commercial Distribution

9500

  • Cardiopulmonary resuscitation mask, single-use
Soft Pressure Dressing
ADVANCE MEDICAL DESIGNS, INC.
2019NS
In Commercial Distribution

  • 10848340005555 ()
  • 00848340005558 ()


  • Pressure bandage, non-latex, sterile
Soft Pressure Dressing
ADVANCE MEDICAL DESIGNS, INC.
2019
In Commercial Distribution

  • 10848340002011 ()
  • 00848340002014 ()


  • Pressure bandage, non-latex, sterile
Silver-coated antibacterial barrier dressing
SMITH & NEPHEW MEDICAL LIMITED
66800057
In Commercial Distribution

  • 05000223468187 ()
  • 05000223477417 ()
  • 05000223468194 ()
66800057

  • Wound-nonadherent dressing, absorbent, antimicrobial
Silver-coated antibacterial barrier dressing
SMITH & NEPHEW MEDICAL LIMITED
66021771
In Commercial Distribution

  • 05000223459345 ()
  • 05000223477394 ()
  • 05000223459598 ()
66021771

  • Wound-nonadherent dressing, absorbent, antimicrobial
Silicone gel adhesive hydrocellular foam dressing with Silver
SMITH & NEPHEW MEDICAL LIMITED
66800463
In Commercial Distribution

  • 05000223466053 ()
  • 05000223466046 ()
  • 05000223466060 ()
66800463

  • Wound-nonadherent dressing, absorbent, antimicrobial
Silicone gel adhesive hydrocellular foam dressing with Silver
SMITH & NEPHEW MEDICAL LIMITED
66800454
In Commercial Distribution

  • 05000223465933 ()
  • 05000223465926 ()
  • 05000223465940 ()
66800454

  • Wound-nonadherent dressing, absorbent, antimicrobial
Silicone gel adhesive hydrocellular foam dressing with Silver
SMITH & NEPHEW MEDICAL LIMITED
66800452
In Commercial Distribution

  • 05000223465872 ()
  • 05000223465865 ()
  • 05000223465889 ()
66800452

  • Wound-nonadherent dressing, absorbent, antimicrobial
Non-Adhesive antimicrobial hydrocellular heel dressing
SMITH & NEPHEW MEDICAL LIMITED
66800098
In Commercial Distribution

  • 05000223461935 ()
  • 05000223461928 ()
  • 05000223462666 ()
66800098

  • Wound-nonadherent dressing, absorbent, antimicrobial
Non-Adhesive antimicrobial hydrocellular dressing
SMITH & NEPHEW MEDICAL LIMITED
66020981
In Commercial Distribution

  • 05000223460020 ()
  • 05000223460013 ()
  • 05000223460037 ()
66020981

  • Wound-nonadherent dressing, absorbent, antimicrobial
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