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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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EdgeEndo EDTA is an EDTA solution in water with surfactant to lower surface tension. The solution is a root canal cleanser for use in endotontic procedures to remove the smear layer.
EDGE ENDO LLC
EEEDTA
In Commercial Distribution

  • 00818365020058 ()

  • Total Volume: 480 Milliliter


  • Dental tooth-cleaning solution
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
9550-G (w Key Ring/Belt Loop Case & Gloves)
In Commercial Distribution

9550-G

  • Cardiopulmonary resuscitation mask, single-use
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
9550-G (w Key Ring/Belt Loop Case & Gloves)
Not in Commercial Distribution

  • 06343760095577 ()
9550-G

  • Cardiopulmonary resuscitation mask, single-use
Spanish - Anasept Antimicrobial Skin and Wound cleanser filled in 8 oz. cone top, HDPE bottles with Trigger sprayer
ARGENTUM MEDICAL, LLC
4008TCS
In Commercial Distribution

  • 10857278000914 ()
  • 00857278000917 ()


  • Antimicrobial wound irrigation solution
Anasept Antimicrobial Skin and Wound cleanser filled in 15 oz. HDPE bottles with dispensing cap
ARGENTUM MEDICAL, LLC
4016C
In Commercial Distribution

  • 10856040008394 ()
  • 00856040008397 ()


  • Antimicrobial wound irrigation solution
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 us 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
9550 (packaged in Key Ring/Belt Loop case
Not in Commercial Distribution

  • 06343760395509 ()
MKIS9550

  • Cardiopulmonary resuscitation mask, single-use
The Rondex CPR REDI-SHIELD is a mouth-to-mask barrier device used to help a rescuer avoid direct contact with the patient when doing resuscitation. Barrier surface area (6" X 6") helps isolate the rescuer from the patient. The barrier material is attached to a short bite block containing one (1) silicone valve 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 ventilation much easier when doing the head tilt/chin lift procedure. The short bite block, 1/2" in length, reduces the risk of pushing the patient's tongue back and does not require a prescription. The REDI-SHIELD with a bite block advantage is very compact and is ideal for unitized packaging in first aid kits and key ring cases. 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. REDI-SHIELD(TM) of Rondex MADE IN USA.
RONDEX PRODUCTS, INCORPORATED
9850 (packaged in key ring flap closer case)
Not in Commercial Distribution

  • 06343760398500 ()
MKRS9850

  • Cardiopulmonary resuscitation mask, single-use
Referencells (Pooled Cells) are intended for use in tube and microplate ABO serum grouping tests.
IMMUCOR, INC.
0066900
In Commercial Distribution

  • 10888234001522 ()
0066900

  • Solid-phase red blood cell adherence antibody/antigen IVD
Silver-sept Antimicrobial Skin and Wound Gel filled in a 3 oz. tube with dispensing cap
ARGENTUM MEDICAL, LLC
3003S
In Commercial Distribution

  • 00856040008878 ()
  • 00856040008861 ()


  • Wound hydrogel dressing, antimicrobial
Anasept Antimicrobial Skin and Wound Gel filled in 3 oz. tube with dispensing cap (Spanish)
ARGENTUM MEDICAL, LLC
5003GS
In Commercial Distribution

  • 00856040008823 ()
  • 00856040008816 ()


  • Wound hydrogel dressing, antimicrobial
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