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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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Dry Mouth Lozenge
CHURCH & DWIGHT CO., INC.
00697029471005
In Commercial Distribution

  • 80697029241123 ()
  • 00697029471005 ()


  • Artificial saliva
Dry Mouth Rinse
CHURCH & DWIGHT CO., INC.
00697029383414
In Commercial Distribution

  • 00697029383414 ()


  • Artificial saliva
Dry Mouth Lozenge
CHURCH & DWIGHT CO., INC.
00697029340103
In Commercial Distribution

  • 80697029118838 ()
  • 00697029340103 ()


  • Artificial saliva
Dry Mouth Lozenge
CHURCH & DWIGHT CO., INC.
00697029241127
In Commercial Distribution

  • 80697029241123 ()
  • 00697029241127 ()


  • Artificial saliva
Dry Mouth Lozenge
CHURCH & DWIGHT CO., INC.
00697029118832
In Commercial Distribution

  • 80697029118838 ()
  • 00697029118832 ()


  • Artificial saliva
No Description
Ouraring Inc.
Fertile Window iOS
In Commercial Distribution

  • 06430060159990 ()


  • Menstrual cycle self-monitoring software
No Description
Ouraring Inc.
Fertile Window Android
In Commercial Distribution

  • 06430060159983 ()


  • Menstrual cycle self-monitoring software
The HSI CPR REDI-SHIELD model #9850-G comes in a zipper 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
Not in Commercial Distribution

  • 06343760498576 ()


  • 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-Z (packaged in key ring zipper case)
Not in Commercial Distribution

  • 06343760398517 ()
MKRS9850Z

  • 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
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