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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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Hyperinflation System, 1/2L bag (not made with Latex), 7' O2 and pressure lines, Infant mask, 40 cm H2O pop-valve
WESTMED, INC.
900 000 616
Not in Commercial Distribution

  • 05707480137572 ()
  • 05707480137565 ()


  • Ventilator breathing circuit, single-use
Disposable Hyperinflation System, 1/2L bag (not made with latex), 7' O2 and pressure Lines, Neonatal mask, H2O Pop-off valave
WESTMED, INC.
600 000 615
In Commercial Distribution

  • 05707480137558 ()
  • 05707480137541 ()


  • Ventilator breathing circuit, single-use
Disposable Hyperinflation System, 1/2 Bag 7' O2 and Manometer 40 cm H2O Pop-Off Valve
WESTMED, INC.
900 000 614
In Commercial Distribution

  • 05707480137534 ()
  • 05707480137527 ()


  • Ventilator breathing circuit, single-use
Hyperinflation System, 1/2L Bag (not made with latex), 7' O2 and Pressure Lines, 40 cm H2O pop-valve
WESTMED, INC.
900 000 627
Not in Commercial Distribution

  • 05707480137510 ()
  • 05707480137503 ()


  • Ventilator breathing circuit, single-use
15.4 cu ft irrigation fluid warmer
ENTHERMICS, INC.
P-2040
In Commercial Distribution

  • 00851962007718 ()


  • Multi-purpose warming cabinet, stationary
15.4 cu ft irrigation fluid warmer
ENTHERMICS, INC.
MED3373
In Commercial Distribution

  • 00851962007701 ()


  • Multi-purpose warming cabinet, stationary
15.4 cu ft irrigation fluid warmer
ENTHERMICS, INC.
EC1540
In Commercial Distribution

  • 00851962007695 ()


  • Multi-purpose warming cabinet, stationary
Experience fast relief from muscle and joint pain with our state-of-the-art Frozen Ice Cold Therapy Machine. The ergonomic therapy pad provides comprehensive coverage, targeting areas like the knee, ankle, shoulder, and more, ensuring deep therapeutic comfort.
BRACE ALIGN LLC
CTY194-Unit-Plus-Uni-Pad
In Commercial Distribution

  • 00686162753284 ()


  • Circulating-fluid localized thermal therapy system
Experience targeted relief from joint pain, post-workout fatigue, and post-surgery inflammation with the Brace Direct Frozen Heat Therapy Unit. Portable, versatile, and designed for both cold and hot treatments to speed up recovery.
BRACE ALIGN LLC
CTY159-2
In Commercial Distribution

  • 00686162751389 ()


  • Circulating-fluid localized thermal therapy system
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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