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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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No Description
SPECTRUM MEDICAL SRL
SPC-200R
In Commercial Distribution

  • 28051160302509 ()


  • Cardiopulmonary bypass system blood tubing set
No Description
SPECTRUM MEDICAL SRL
SPC-160
Not in Commercial Distribution

  • 28051160302479 ()


  • Cardiopulmonary bypass system blood tubing set
No Description
SPECTRUM MEDICAL SRL
SPC-200
Not in Commercial Distribution

  • 28051160302462 ()


  • Cardiopulmonary bypass system blood tubing set
No Description
SPECTRUM MEDICAL SRL
CP20V-V0U
In Commercial Distribution

  • 18051160302144 ()


  • Cardiopulmonary bypass system centrifugal pump
No Description
SPECTRUM MEDICAL SRL
SP05E-AA
In Commercial Distribution

  • 18051160302717 ()


  • Cardiopulmonary bypass system blood tubing set
No Description
SPECTRUM MEDICAL SRL
DL31F-V1
In Commercial Distribution

  • 18051160302694 ()


  • Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, drainage
No Description
Starkey Laboratories, Inc.
EVOLV AI CIC
In Commercial Distribution

  • 00842318189738 ()


  • Tinnitus masking application software
  • Air-conduction hearing aid, canal
The LifeWarmer Quantum Thermal Infusion Set (TIS) is the revolutionary IV tubing set that allows for safe, rapid warming of IV fluids without adding hardly any additional steps to the normal IV setup process. Modeled after standard IV 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 IV 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 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 approximately 1700 mL of 20C IV solution to a set point of 100.4F (38 +/- 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
63-5903
In Commercial Distribution

  • 00868058000461 ()
  • 00868058000409 ()
35-0004

  • Conduction blood/fluid warmer
No Description
SPECTRUM MEDICAL SRL
CONN-HX2
In Commercial Distribution

  • 08051160301577 ()


  • Cardiopulmonary bypass system heat exchanger, single-use
No Description
SPECTRUM MEDICAL SRL
CONN-HX1
In Commercial Distribution

  • 08051160301560 ()


  • Cardiopulmonary bypass system heat exchanger, single-use
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