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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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BagEasy, Adult Resuscitator, W/Mask (Uncollapsed)
WESTMED, INC.
562201
In Commercial Distribution

  • 10709078008068 ()
  • 00709078008061 ()


  • Pulmonary resuscitator, manual, single-use
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
PULMONARY RESUSCITATOR, MANUAL FOR INFANTS
KENTRON HEALTHCARE, INC.
779502
In Commercial Distribution

  • 00866512000224 ()
  • 10866512000221 ()
779502

  • Pulmonary resuscitator, manual, single-use
PULMONARY RESUSCITATOR, MANUAL FOR CHILDREN
KENTRON HEALTHCARE, INC.
779501
In Commercial Distribution

  • 00866512000217 ()
  • 10866512000214 ()
779501

  • Pulmonary resuscitator, manual, single-use
PULMONARY RESUSCITATOR, MANUAL
KENTRON HEALTHCARE, INC.
779500
In Commercial Distribution

  • 00866512000200 ()
  • 10866512000207 ()
779500

  • Pulmonary resuscitator, manual, single-use
Cross-Linked Hyaluronic Acid and Lidocaine Injectable Gel
Anika Therapeutics, Inc.
685-310
Not in Commercial Distribution

  • 00866142000014 ()


  • Dermal tissue reconstructive material, microbe-derived, anaesthetic
Cross-Linked Hyaluronic Acid and Lidocaine Injectable Gel
Anika Therapeutics, Inc.
685-015
In Commercial Distribution

  • 00866142000007 ()


  • Dermal tissue reconstructive material, microbe-derived, anaesthetic
No Description
Altitude Technologies Inc.
1373
In Commercial Distribution

  • 00856767008052 ()


  • Pulmonary resuscitator, manual, single-use
KIT STYLETTO 3AX EU SNW RGD
Ws Audiology Usa, Inc.
KIT Styletto 3AX
In Commercial Distribution

  • 05714880142587 ()
21003668

  • Convection blood/fluid warmer set
SPUR II Ped Bag Res, Tod FM, Mano, Disp PEEP, 10' Ox Tube
Ambu A/S
530613047
Not in Commercial Distribution

  • 05707480110469 ()
  • 05707480110476 ()

  • Pediatric
530613047

  • Pulmonary resuscitator, manual, single-use
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