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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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Incubator; 20 Liter (0.7 cubic feet)
LW SCIENTIFIC, INC.
ICL-020L-D072
In Commercial Distribution

  • 00664816002346 ()
ICL-020L-D072

  • Multi-purpose warming cabinet, stationary
Incubator; 10 Liter (.35 cubic feet)
LW SCIENTIFIC, INC.
ICL-010L-D031
In Commercial Distribution

  • 00664816002339 ()
ICL-010L-D031

  • Multi-purpose warming cabinet, stationary
Incubator; 20 Liter (0.7 cubic feet)
LW SCIENTIFIC, INC.
ICL-020L-D071
In Commercial Distribution

  • 00664816002315 ()
ICL-020L-D071

  • Multi-purpose warming cabinet, stationary
Incubator; 10 Liter (.35 cubic feet)
LW SCIENTIFIC, INC.
ICL-010L-D032
In Commercial Distribution

  • 00664816002308 ()
ICL-010L-D032

  • Multi-purpose warming cabinet, stationary
Water Bath - circulating, variable temp, 10 liter, 110V
LW SCIENTIFIC, INC.
WBL-10LC-SSD1
In Commercial Distribution

  • 00664816001592 ()
WBL-10LC-SSD1

  • Laboratory water bath
Water Bath - circulating, variable temp, 20 liter, 110V
LW SCIENTIFIC, INC.
WBL-20LC-SSD1
In Commercial Distribution

  • 00664816001431 ()
WBL-20LC-SSD1

  • Laboratory water bath
Pipette Shaker - timer, 2500 rpms, holds 6
LW SCIENTIFIC, INC.
SHL-PPF7-06F1
In Commercial Distribution

  • 00664816001400 ()
SHL-PPF7-06F1

  • Laboratory shaker
The Lifewarmer Quantum Blood and Fluid Warming System (IV Fluid ONLY Configuration) 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 TIS (Thermal Infusion Set) NOTE: TIS is Single Use Only, Supplied sterile via Ethylene Oxide and Not Intended for use with Blood and Blood Products
NORTH AMERICAN RESCUE, LLC
63-5906
In Commercial Distribution

  • 00868058000492 ()
35-0007

  • Conduction blood/fluid warmer
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
The Life Warmer Quantum Controller is the command center of the Quantum Blood and Fluid Warming System. It contains the microprocessor and control algorithm that continually assesses temperature input from tubing thermistors and regulates the energy provided to the tubing heating elements in the proximal and/or distal segments to reach and maintain temperature between 100.4°F (38°+/- 2°C) at patient delivery. The Controller receives power when connected to the Battery and modulates the energy flow to the TIS/TTS-B. The Quantum Controller has two connections, one for the battery and one for the Thermal Tubing of choice. The connection to the battery is an omni-directional plug for ease of insertion and the connection is safe and secure. The connection to the TIS or TTS-B is bi-directional and simple to execute- it’s plug and play. The Controller has LED lights on the shoulder of the device to inform the user about the output temperature and flow of the fluid. It will visually alert the care provider to the status of the system. The Controller is reusable and comes fitted with a Jacket that permits the mating (connection) of the TIS or TTS-B Life Warmer tubing circuit connector to the connector slot on the Controller.
NORTH AMERICAN RESCUE, LLC
63-5901
In Commercial Distribution

  • 00868058000447 ()
35-0003

  • Conduction blood/fluid warmer
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