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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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Refurbished Brace Direct Cryotherapy Machine – Advanced Cold Therapy for Faster Recovery Experience the power of cold therapy with our refurbished Brace Direct Cryotherapy Machine. Expertly restored for peak performance, it helps relieve post-surgical pain, arthritis, muscle spasms, and sports injuries. Compact, quiet, and easy to use—your go-to for faster recovery and lasting relief.
BRACE ALIGN LLC
UCTY194-2
In Commercial Distribution

  • 00860011821847 ()


  • Circulating-fluid localized thermal therapy system
Water circulating hot or cold pack.
Ermi LLC
THR
In Commercial Distribution

  • 00860011691501 ()


  • Circulating-fluid localized thermal therapy system
Ebb Insomnia Therapy headgear assembly without the tube sleeve for clinical demonstrations to allow the tubing to be wiped down for cleaning.
CEREVE INC
EOS-30000-054
In Commercial Distribution

  • 00864302000355 ()
10401

  • Circulating-fluid localized thermal therapy system
Ebb Insomnia Theraypy is a wearable therapy system with a bedside controller, forehead pad and tubing, fluid cartridge, and power supply that cools the forehead while the patient sleeps. This listing is for the replacement cartridge.
CEREVE INC
EOS-30000-031
In Commercial Distribution

  • 00864302000331 ()


  • Circulating-fluid localized thermal therapy system
Packages an Ebb Insomnia Therapy Starter kit with a replenish kit, 2 replacement cartridges and a travel bag.
CEREVE INC
VA Kit
In Commercial Distribution

  • 00864302000317 ()


  • Circulating-fluid localized thermal therapy system
Histogel™ Starter Kit includes: Wonderblock Aluminum Cooling Blocks, Histogel™, Histogel™ Incubator & Tube Block, Disposable Pipettes and Thermometer (Mercury Free).
RICHARD-ALLAN SCIENTIFIC COMPANY
Histogel™ Starter Kit 120V
In Commercial Distribution

  • 00673693344692 ()
HGSK-2050-1

  • Test tube heater
  • Agar powder IVD
Ebb Insomnia Theraypy is a wearable therapy system with a bedside controller, forehead pad and tubing, fluid cartridge, and power supply that cools the forehead while the patient sleeps. This listing is for the replacement forehead pad with tubing.
CEREVE INC
EOS-30000-013
In Commercial Distribution

  • 00864302000348 ()


  • Circulating-fluid localized thermal therapy system
Replenish kit including replacement fluid cartridge and headgear with tubing for the Ebb Insomnia Therapy system.
CEREVE INC
10200
In Commercial Distribution

  • 00864302000324 ()


  • Circulating-fluid localized thermal therapy system
Ebb Insomnia Theraypy is a wearable therapy system with a bedside controller, forehead pad and tubing, fluid cartridge, and power supply that cools the forehead while the patient sleeps.
CEREVE INC
EOS-30000-007
In Commercial Distribution

  • 00864302000300 ()


  • Circulating-fluid localized thermal therapy system
The LifeWarmer Quantum Battery is an extremely powerful and intelligent battery in a small, lightweight package- weighing only 16 oz. The Quantum Battery powers the whole warming system with state-of-the-art Lithium Polymer cells harnessing 44 Volts of electrical potential. The battery, 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 100.4°F (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. The Quantum Battery is built for use in the most austere and tactical environments. It is IP67 rated for water resistance and is the only portable fluid warming battery that has a disable feature on the audible alarm for tactical considerations. The Quantum Life Warmer Battery is rechargeable with a service life of 500 charge/discharge cycles. It is important to keep the Quantum Battery charged and ready for use. Always re-charge after deployment, even if the battery was not fully discharged. The battery can be kept plugged into the Quantum Charger, as the intelligent Battery senses charge demand and will charge as needed but never overcharge. The Battery has a “Status” button to check the state of charge at any moment, with 3 colored LEDs to inform the user about the condition of the battery.
NORTH AMERICAN RESCUE, LLC
63-5902
In Commercial Distribution

  • 00868058000423 ()
35-0001

  • Conduction blood/fluid warmer
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