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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 Thermal Transfusion Set- Blood is the revolutionary IV tubing set that allows for safe, rapid warming of blood, blood products, or IV fluids without adding hardly any additional steps to the normal IV setup process. Modeled after standard blood 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 blood 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 (thermal resistors) 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 2 units ( 900mL +/- 100mL) of cold (4C) blood products or IV solutions to a pre-set temperature of 100.4F (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. Effective warming flow rates range from 2 to 200 mL/minute depending on input fluid temperature and ambient conditions.
NORTH AMERICAN RESCUE, LLC
63-5904
In Commercial Distribution

  • 00868058000454 ()
  • 00868058000416 ()
35-0005

  • Conduction blood/fluid warmer set
Manual Resuscitator, Durable, Infant - with Small Infant (Size 0) Resuscitation Mask and Reservoir
TELEFLEX INCORPORATED
IPN044932
In Commercial Distribution

  • 14026704613684 ()
  • 24026704613681 ()
  • 04026704613687 ()

  • Length: 5.39 Inch
5347

  • Pulmonary resuscitator, manual, reusable
Manual Resuscitator, Durable, Child - with Small Svhild (Size 2) Resuscitation Mask and Reservoir
TELEFLEX INCORPORATED
IPN044931
In Commercial Distribution

  • 14026704613639 ()
  • 24026704613636 ()
  • 04026704613632 ()

  • Length: 5.39 Inch
5346

  • Pulmonary resuscitator, manual, reusable
Manual Resuscitator, Durable, Adult - with Large Resuscitation Mask and Reservoir
TELEFLEX INCORPORATED
IPN044930
In Commercial Distribution

  • 14026704613622 ()
  • 24026704613629 ()
  • 04026704613625 ()

  • Length: 8.27 Inch
5345

  • Pulmonary resuscitator, manual, reusable
Manual Resuscitator, Durable, Infant
TELEFLEX INCORPORATED
IPN044928
In Commercial Distribution

  • 14026704613615 ()
  • 24026704613612 ()
  • 04026704613618 ()

  • Length: 8.27 Inch
5342

  • Pulmonary resuscitator, manual, reusable
Manual Resuscitator, Durable, Infant - with Small Infant (Size 0)Resuscitation Mask and Reservoir
TELEFLEX INCORPORATED
IPN039379
In Commercial Distribution

  • 34026704662402 ()
  • 14026704662408 ()
  • 04026704613687 ()
5347

  • Pulmonary resuscitator, manual, reusable
Manual Resuscitator, Durable, Child - with Small Child (Size 2)Resuscitation Mask and Reservoir
TELEFLEX INCORPORATED
IPN039378
In Commercial Distribution

  • 34026704662396 ()
  • 14026704662392 ()
  • 04026704613632 ()
5346

  • Pulmonary resuscitator, manual, reusable
Manual Resuscitator, Durable, Adult - with LargeResuscitation Mask and Reservoir
TELEFLEX INCORPORATED
IPN039377
In Commercial Distribution

  • 34026704662389 ()
  • 14026704662385 ()
  • 04026704613625 ()
5345

  • Pulmonary resuscitator, manual, reusable
The NeoNatalie Resuscitator is a self-inflating, manual resuscitator intended for newborns and infants up to 5 kg body mass who require respiratory support.
Laerdal Medical AS
LGH-84604001
In Commercial Distribution

  • 07045432092042 ()
  • 07045432092035 ()
LGH-84604001

  • Pulmonary resuscitator, manual, reusable
The NeoNatalie Resuscitator is a self-inflating, manual resuscitator intended for newborns and infants up to 5 kg body mass who require respiratory support. This kit includes NeoNatalie Resuscitator LGH-84604001 filed as DI 07045432092035 in GUDID.
Laerdal Medical AS
LGH-104-10004
In Commercial Distribution

  • 07045432091168 ()

  • Weight: 5 Kilogram
LGH-104-10004

  • Pulmonary resuscitator, manual, reusable
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