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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Cardiac Tube Holder
ORANGE SURGICAL INSTRUMENTS, LLC
OSCVORTH
In Commercial Distribution

  • B354OSCVORTH0 ()


  • Tissue extraction bag
  • Endoscopic electrosurgical electrode, monopolar, single-use
  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Insufflation gas conditioning tubing set
  • Laparoscopic wound closure thread
The LifeWarmer Quantum Thermal Transfusion Set- Blood is the revolutionary IV tubing set that allows for safe, rapid warming of blood, blood products, or IV fluids without adding hardly any additional steps to the normal IV setup process. Modeled after standard blood infusion tubing, the familiar configuration allows for ease of use. The sophisticated intelligence and proprietary warming technology are integrated into the tubing system for simplicity and to reduce additional equipment and procedural steps. Roughly the same size and weight as standard blood tubing, there is almost no additional equipment burden. The Quantum IV administration tubing is double-extruded to yield a configuration that has both an inner tubing layer and an outer tubing layer. A conductive heating element is between the two layers but does not come in contact with the fluid path or disrupt the laminar flow. The outer tubing layer acts as an insulator while the inner tubing layer transfers the heat from the heating element to the fluid path. Thermistors (thermal resistors) located in the tubing continually measure temperature and provide that input to the Quantum Controller. The monitoring and independent application of energy (heat) along the fluid path allows the Quantum to respond to varying temperature inputs from the fluid source to near the point of patient entry to ensure fluid temperature is the right temperature at delivery. The Quantum Life Warmer, fully charged, is able to warm and maintain up to 2 units ( 900mL +/- 100mL) of cold (4C) blood products or IV solutions to a pre-set temperature of 100.4F (38+/- 2C) at a flow rate of 100 mL/min (depending on the ambient temperature). Or, approximately 1700 mL of 20C IV solution to a set point of 38C +/- 2C at a flow rate of 200 mL/min. Effective warming flow rates range from 2 to 200 mL/minute depending on input fluid temperature and ambient conditions.
NORTH AMERICAN RESCUE, LLC
63-5904
In Commercial Distribution

  • 00868058000454 ()
  • 00868058000416 ()
35-0005

  • Conduction blood/fluid warmer set
PEDS BLOOD CULTURE KIT, NORTHWESTER
AERO-MED, LLC
CA9300
In Commercial Distribution

  • 50885380138964 ()
  • 10885380138966 ()
CA9300

  • Phlebotomy kit
Assistant Free Calibrated Bone Spreader, small with grooved 23 x 12mm pads, opens to 39mm, 7" OL, calibrated markings: 10, 15, 20, 25, 30, 35mm
Avalign Technologies, Inc.
1-1850M
In Commercial Distribution

  • 00190776396114 ()


  • Hand-held surgical retractor, reusable
Replacement Pads For Band Remover Instruments (Autoclavable)
Young Innovations, Inc.
875-214P
In Commercial Distribution

  • 10840326420734 ()
  • 00840326420737 ()
875-214P

  • Orthodontic pliers
Lombardi Femoral Tibial Spreader, small, diamond cut pads, 7" OL, 22mmx13mm pads, opens to 35mm
Avalign Technologies, Inc.
1-1876D
In Commercial Distribution

  • 00190776380915 ()


  • Self-retaining surgical retractor, reusable
Calibrated Femoral Tibial Spreader, medium with diamond cut pads
Avalign Technologies, Inc.
1-1855D
In Commercial Distribution

  • 00190776379223 ()


  • Hand-held surgical retractor, reusable
GAUZE SPONGE, 8 PLY, 4" X 4", STERILE
Asp Global, LLC
NPT448
In Commercial Distribution

  • 00840216103887 ()


  • Non-woven gauze pad
NONWOVEN SPONGE, 4 PLY, 4"X4", STERILE
Asp Global, LLC
NPT444
In Commercial Distribution

  • 00840216103870 ()


  • Non-woven gauze pad
GAUZE SPONGE, 12 PLY, 4" X 4", STERILE
Asp Global, LLC
NPT442
In Commercial Distribution

  • 00840216103863 ()


  • Non-woven gauze pad
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