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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 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)
Not in Commercial Distribution

  • 06343760098004 ()
9800

  • Cardiopulmonary resuscitation mask, single-use
Custom cut to length.The SuperPole is a high quality, commercial grade floor to ceiling safety pole. The SuperPole must be installed between a structural floor and ceiling by turning a jackscrew at the bottom of the pole. The pressure created by the jackscrew is strong enough for the SuperPole to support the user, yet it does not require drilling holes into the floor or ceiling. This is ideal for relocating or removing the pole. NOTE: The top plate has two holes that may be used to fix the plate directly to the ceiling joist if necessary. Do not install the pole where it is directly exposed to water.
Healthcraft Products Inc.
SP-P-CUT
In Commercial Distribution

  • 00689281015967 ()
01596

  • Hand rail
Silicone-Based Personal Lubricant
CC Wellness LLC
79019-IH
In Commercial Distribution

  • 10796494005887 ()
  • 00796494005880 ()


  • Sexual lubricant
No Description
ALIMED, INC.
91-598
In Commercial Distribution

  • 00733657244113 ()
2970011674

  • Limb/torso/head restraint, reusable
No Description
MIZUHO ORTHOPEDIC SYSTEMS, INC.
CT-356509185
In Commercial Distribution

  • 00842430111099 ()
CT-356509185

  • Operating table mattress, basic
No Description
Joicom Corporation
RP-BPM001S
In Commercial Distribution

  • 10850023727012 ()
  • 00850023727015 ()


  • Automatic-inflation electronic sphygmomanometer, portable, arm/wrist
No Description
Hubei Huamei Sunlight Biotechnologies Co., Ltd
MIC-45H-30S
In Commercial Distribution

  • 36970299144349 ()
  • 16970299144345 ()


  • Mechanical pipette
Disposable Reflective Spheres attached to reference frames and surgical instruments for use during surgical navigation in image guided surgery. One retail carton is made up of 5 spheres per tray in a pouch. There are 12 tray-in-pouches for a total of 60 spheres.
Northern Digital Inc
8801075
In Commercial Distribution

  • 20805832070030 ()
  • 00805832070036 ()
8801075

  • Imaging lesion localization marker, external, single-use
Disposable Reflective Spheres attached to reference frames and surgical instruments for use during surgical navigation in image guided surgery. One retail carton is made up of 4 spheres per tray in a pouch. There are 12 tray-in-pouches for a total of 48 spheres.
Northern Digital Inc
8801074
In Commercial Distribution

  • 20805832070023 ()
  • 00805832070029 ()
8801074

  • Imaging lesion localization marker, external, single-use
Disposable Reflective Spheres attached to reference frames and surgical instruments for use during surgical navigation in image guided surgery. One retail carton is made up of 1 sphere per tray in a pouch. There are 12 tray-in-pouches for a total of 12 spheres.
Northern Digital Inc
8801071
In Commercial Distribution

  • 20805832070016 ()
  • 00805832070012 ()
8801071

  • Imaging lesion localization marker, external, single-use
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