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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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The Lifewarmer Quantum Charger from is an AC-powered reusable device that can fully charge the Quantum Battery rapidly and safely. The Charger has built-in algorithms to ensure proper, steady charging without overcharging or damaging the health and integrity of the battery. The Battery can go from nearly 0% to full within 90 minutes. The Life Warmer Charger has two colored LED lights to inform the provider of the status of charge and condition of the battery. The Quantum Battery Charger connects to the Battery via an omni-directional plug that allows for rapid energy transfer while prioritizing safety even in cases of hasty disconnection. The Quantum Battery will alert the user if there is any issue associated with the health of the battery. The Charger comes supplied with a 6-foot AC power cord.
NORTH AMERICAN RESCUE, LLC
63-5905
In Commercial Distribution

  • 00868058000430 ()
35-0002

  • Conduction blood/fluid warmer
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
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
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 forehead pad with tubing.
CEREVE INC
EOS-30000-013
In Commercial Distribution

  • 00864302000348 ()


  • 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
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
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
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
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
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