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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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WoundSeal® + Applicator
BIOLIFE, L.L.C.
NCW001
In Commercial Distribution

  • 00834061000026 ()
  • 00834061000415 ()
  • 00834061004413 ()
NCW001

  • Non-organic haemostatic agent
WoundSeal® Rapid Response
BIOLIFE, L.L.C.
WSO001
In Commercial Distribution

  • 00834061006318 ()
  • 00834061000019 ()
WSO001

  • Non-organic haemostatic agent
L-Mesitran Soft is wound dressing for the use on wounds. L-Mesitran Soft is a gel that contains: 40% medical grade honey, lanolin, propylene glycol, PEG 4000, and vitamins C and E.
Theo Manufacturing B.V.
205.01.US
In Commercial Distribution

  • 08717249680741 ()

  • Weight: 50 Gram


  • Medical honey liquid barrier dressing
L-Mesitran Soft is wound dressing for the use on wounds. L-Mesitran Soft is a gel that contains: 40% medical grade honey, lanolin, propylene glycol, PEG 4000, and vitamins C and E.
Theo Manufacturing B.V.
203.01.US
In Commercial Distribution

  • 08717249680734 ()

  • Weight: 15 Gram


  • Medical honey liquid barrier dressing
For Administration of Blood and Blood Components During a Therapeutic Plasma Exchange (TPE) or Red Blood Cell Exchange (RBCX) Therapeutic Apheresis Procedure. For use with the AMICUS separator. Sterile Fluid Path.
Fresenius Kabi AG
X6C2170
In Commercial Distribution

  • 04086000100168 ()
  • 04052682031717 ()
  • 14052682031714 ()
X6C2170

  • Blood transfusion set, non-exchange
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 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 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
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