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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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Prevahex Antimicrobial Transparent Film Dressings, Frame Style, 2.375 IN x 2.75 IN, 400 Dressings/Case, 1484CH
Entrotech Life Sciences, LLC
1484BOX
In Commercial Distribution

  • B5591484BOX1 ()
  • B5591484CH0 ()
  • B5591484CASE3 ()
1484BOX

  • Antimicrobial synthetic polymer semi-permeable film dressing, adhesive
Prevahex Antimicrobial Transparent Film Dressings, Frame Style, 1.75 IN x 1.75 IN, 400 Dressings/Case, 1483CH
Entrotech Life Sciences, LLC
1483BOX
In Commercial Distribution

  • B5591483BOX1 ()
  • B5591483CH0 ()
  • B5591483CASE3 ()
1483BOX

  • Antimicrobial synthetic polymer semi-permeable film dressing, adhesive
Extra Large, Flexible Fabric Antibacterial Bandages, 2 IN x 4 IN (50 mm x 101 mm)
WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
865378
In Commercial Distribution

  • 00050428345580 ()
  • 10050428345587 ()


  • Skin-cover adhesive strip, antimicrobial
Antibacterial Non-Stick Pads, all one size, 3 IN x 4 IN (76 mm x 101 mm)
DISCOUNT DRUG MART, INC.
093351027819
In Commercial Distribution

  • 20093351027813 ()
  • 00093351027819 ()
  • 60093351027811 ()


  • Wound-nonadherent dressing, absorbent, antimicrobial
3M™ Promogran Prisma™ Rope Collagen Matrix with ORC and Silver, MA032, 3/8 in x 3/8 in x 12-5/8 in, 6/Ct
3M Deutschland GmbH
MA032
In Commercial Distribution

  • 04054596955806 ()
  • 04054596955790 ()
  • 04054596955783 ()
MA032

  • Collagen wound matrix dressing
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
9500 (packaged in poly bag)
In Commercial Distribution

9500

  • 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
9500 (packaged in poly bag)
Not in Commercial Distribution

  • 06343760095003 ()
9500

  • Cardiopulmonary resuscitation mask, single-use
Calcium Alginate Ag (Silver) 12" Rope Dressing
Gentell, LLC
GEN-13142
In Commercial Distribution

  • 00361554001043 ()
  • 00361554001036 ()
  • 00361554001029 ()
GEN-13142

  • Exudate-absorbent dressing, hydrophilic-gel, antimicrobial
Mack's Earplugs - 2 Pair in Clamshell Case
NAVAJO MANUFACTURING COMPANY
26618
In Commercial Distribution

  • 00024291266181 ()


  • Earplugs, reusable
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