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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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Compressor
Pioneer Surgical Technology, Inc.
83-L-COMPRESSOR
Not in Commercial Distribution

  • 00846468047818 ()
83-L-COMPRESSOR

  • General internal orthopaedic fixation system implantation kit
Driver
Pioneer Surgical Technology, Inc.
83-DRIVER
Not in Commercial Distribution

  • 00846468047801 ()
83-DRIVER

  • Orthopaedic counter-torque/rod-pushing instrument
8mm Dilator
Pioneer Surgical Technology, Inc.
83-DILATOR-08
Not in Commercial Distribution

  • 00846468047795 ()
83-DILATOR-08

  • Nerve/vessel retractor
5mm Dilator
Pioneer Surgical Technology, Inc.
83-DILATOR-05
Not in Commercial Distribution

  • 00846468047788 ()
83-DILATOR-05

  • Nerve/vessel retractor
Barrel Plate Inserter
Pioneer Surgical Technology, Inc.
83-B-INSERTER
Not in Commercial Distribution

  • 00846468047757 ()
83-B-INSERTER

  • General internal orthopaedic fixation system implantation kit
The Lifewarmer Quantum Blood and Fluid Warming System is a Game-Changing innovation that has succeeded in closing a critical capability gap previously left exposed by other commercial off-the-shelf fluid warmers currently fielded. Size, weight, performance, and ease of use are no longer collective barriers to the delivery of whole blood in far forward and near point of injury (POI) prehospital casualty management. The Quantum exceeds all healthcare and logistical requirements for the delivery of warmed blood or fluids across the defined spectrum of care. The system consists of unique thermal administration sets that incorporate sensing elements with an integrated heating system that does not disrupt the fluid path. With advanced intelligence throughout the system, the lightweight Controller modulates and moderates the energy flow to the integrated heating elements to ensure consistent normothermic fluid delivery to the casualty. The 44V battery is the smallest in category, able to rapidly adjust power distribution based on the temperature and flow rate of the input fluid. This creates a highly efficient system capable of previously unrealized performance optimizations. The Quantum system has an operational weight of just 22 total ounces yet can deliver two units of 39°F Whole Blood (WB) at 100mL/min with an output temperature of 100.4°F (38°+/- 2°C) with only a 24 second warm-up period. The Quantum Blood and Fluid Warming System provides the Tactical Health Care Professional with significant technological overmatch in the fight to eliminate preventable combat death. Quantum System Contents: 1 x Controller 1 x Battery 1 x Battery Charger 2 x TTS-B (Thermal Transfusion Set - Blood) NOTE: TTS-B is Single Use Only, Supplied sterile via Ethylene Oxide
NORTH AMERICAN RESCUE, LLC
63-5900
In Commercial Distribution

  • 00868058000485 ()
35-0006

  • Conduction blood/fluid warmer
No Description
SPECTRUM MEDICAL SRL
VT160-C2U
In Commercial Distribution

  • 08051160301454 ()


  • Extracorporeal membrane oxygenator
No Description
SPECTRUM MEDICAL SRL
VT200-C2U
In Commercial Distribution

  • 08051160301430 ()


  • Extracorporeal membrane oxygenator
No Description
SPECTRUM MEDICAL SRL
VT160-C2
In Commercial Distribution

  • 08051160300761 ()


  • Extracorporeal membrane oxygenator
No Description
SPECTRUM MEDICAL SRL
VT200-C2
In Commercial Distribution

  • 08051160300709 ()


  • Extracorporeal membrane oxygenator
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