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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
The CINTAS 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
CINTAS #9550-G w Black Key Ring/Belt Loop Case & Gloves
In Commercial Distribution

171110

  • Cardiopulmonary resuscitation mask, single-use
The RONDEX CPR REDI-SHIELD model #9850-G comes in a case with a key ring and gloves. It 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. 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-G (packaged in key ring case)
In Commercial Distribution

9850-G

  • 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 case)
In Commercial Distribution

9850

  • 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
9800-G (package in poly bag with gloves)
In Commercial Distribution

9800-G

  • 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
9800 (packaged in poly bag)
In Commercial Distribution

9800

  • 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)
In Commercial Distribution

9550-G

  • Cardiopulmonary resuscitation mask, single-use
MAJ-1534 CLEANING BRUSH
OLYMPUS MEDICAL SYSTEMS CORP.
MAJ-1534
In Commercial Distribution

  • 14953170208482 ()
  • 04953170208485 ()
N2301000

  • Surgical instrument/endoscope cleaning utensil, reusable
No Description
OLYMPUS MEDICAL SYSTEMS CORP.
MH-140
Not in Commercial Distribution

  • 04953170027123 ()
4386600

  • Surgical instrument/endoscope cleaning utensil, reusable
No Description
OLYMPUS MEDICAL SYSTEMS CORP.
MH-362
In Commercial Distribution

  • 14953170054355 ()
  • 04953170054358 ()


  • Surgical instrument/endoscope cleaning utensil, reusable
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