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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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CM2, THERAPY HAMMER,LASER MODULE, AUTOSOUND, 2X2 MS FOAM, LEAD CORDS, 5CM GELSHOTS & ADAPTOR
COMPASS HEALTH BRANDS CORP.
410-010
Not in Commercial Distribution

  • 00852515007711 ()


  • Transcutaneous electrical stimulation electrode, single-use
  • Physical therapy ultrasound system applicator, hand-held
  • Physical therapy ultrasound/neuromuscular stimulation system
  • Ultrasound coupling pad holder
CM2 220, 5CM, LASER MODULE, 2X2 MS FOAM, LEAD CORDS, 5CM GELSHOTS & ADAPTOR
COMPASS HEALTH BRANDS CORP.
410-010-220
Not in Commercial Distribution

  • 00852515007643 ()


  • Transcutaneous electrical stimulation electrode, single-use
  • Physical therapy ultrasound system applicator, hand-held
  • Physical therapy ultrasound/neuromuscular stimulation system
  • Ultrasound coupling pad holder
CM2 220, 5CM, LASER MODULE, 2X2 MS CLOTH, LEAD CORDS, 5CM GELSHOTS & ADAPTOR
COMPASS HEALTH BRANDS CORP.
410-010-220
Not in Commercial Distribution

  • 00852515007636 ()


  • Ultrasound coupling pad holder
  • Physical therapy ultrasound/neuromuscular stimulation system
CM2 220, THERAPY HAMMER, LASER MODULE, 2X2 MS CLOTH, LEAD CORDS, 5CM GELSHOTS & ADAPTOR
COMPASS HEALTH BRANDS CORP.
410-010-220
Not in Commercial Distribution

  • 00852515007629 ()


  • Transcutaneous electrical stimulation electrode, single-use
  • Physical therapy ultrasound system applicator, hand-held
  • Physical therapy ultrasound/neuromuscular stimulation system
  • Ultrasound coupling pad holder
CM2 220, THERAPY HAMMER,LASER MODULE, AUTOSOUND, 2X2 MS CLOTH, LEAD CORDS, 5CM GELSHOTS & ADAPTOR
COMPASS HEALTH BRANDS CORP.
410-010-220
Not in Commercial Distribution

  • 00852515007605 ()


  • Transcutaneous electrical stimulation electrode, single-use
  • Physical therapy ultrasound system applicator, hand-held
  • Physical therapy ultrasound/neuromuscular stimulation system
  • Ultrasound coupling pad holder
CM2 220, THERAPY HAMMER,LASER MODULE, AUTOSOUND, 2X2 MS FOAM, LEAD CORDS, 5CM GELSHOTS & ADAPTOR
COMPASS HEALTH BRANDS CORP.
410-010-220
Not in Commercial Distribution

  • 00852515007599 ()


  • Transcutaneous electrical stimulation electrode, single-use
  • Physical therapy ultrasound system applicator, hand-held
  • Physical therapy ultrasound/neuromuscular stimulation system
  • Ultrasound coupling pad holder
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
The Vasoview Hemopro 3 Endoscopic Vessel Harvesting System is designed for use in conjunction with the 7 mm Endoscope. The Harvesting Cannula has four lumens which house the Endoscope, C-Ring, distal lens washer tube and Vasoview Hemopro 3 Harvesting Tool for cutting and cauterization of vessel branches. The C-Ring with the built-in distal lens washer is independently controlled by a C-Ring Slider on the handle of the Harvesting Cannula. The C-Ring cradles the vessel and delivers the saline that washes the distal tip of the Endoscope. The Harvesting Tool can be inserted, removed, rotated, extended, and retracted from the main Harvesting Cannula through the Tool Adapter Port. The Harvesting Tool is powered by direct current (DC) only; it does not utilize RF (radio frequency) energy. The Harvesting Tool cuts and cauterizes through a process of heat and pressure. The Harvesting Tool has two curved Jaws. One of the Jaws contains the heating elements for branch cutting and cauterization and spot cautery. There are three heating elements: two cauterization elements and a cutting element between them. Both Jaws have insulation protecting the adjacent tissue. The concave side of the Jaws has a larger buffer of insulation and therefore should be positioned toward sensitive tissue during Jaw activation. An area near the tip of the convex side of the Jaw can be used for spot cautery to cauterize tissue contacted by that area of the Jaw. The Activation Toggle is used to control the Jaws and to activate the heating elements. Positioning of the device, cutting, and cauterization are performed under endoscopic visualization. This device is intended for specific use with the Vasoview Hemopro Power Supply and Vasoview Hemopro 3 Power Adapter.
MAQUET CARDIOVASCULAR LLC
VH-6001
In Commercial Distribution

  • 00607567701335 ()
VH-6001

  • Flexible endoscopic scissors, reusable
The Vasoview Hemopro 3 Endoscopic Vessel Harvesting System is designed for use in conjunction with the 7 mm Endoscope. The Harvesting Cannula has four lumens which house the Endoscope, C-Ring, distal lens washer tube and Vasoview Hemopro 3 Harvesting Tool for cutting and cauterization of vessel branches. The C-Ring with the built-in distal lens washer is independently controlled by a C-Ring Slider on the handle of the Harvesting Cannula. The C-Ring cradles the vessel and delivers the saline that washes the distal tip of the Endoscope. The Harvesting Tool can be inserted, removed, rotated, extended, and retracted from the main Harvesting Cannula through the Tool Adapter Port. The Harvesting Tool is powered by direct current (DC) only; it does not utilize RF (radio frequency) energy. The Harvesting Tool cuts and cauterizes through a process of heat and pressure. The Harvesting Tool has two curved Jaws. One of the Jaws contains the heating elements for branch cutting and cauterization and spot cautery. There are three heating elements: two cauterization elements and a cutting element between them. Both Jaws have insulation protecting the adjacent tissue. The concave side of the Jaws has a larger buffer of insulation and therefore should be positioned toward sensitive tissue during Jaw activation. An area near the tip of the convex side of the Jaw can be used for spot cautery to cauterize tissue contacted by that area of the Jaw. The Activation Toggle is used to control the Jaws and to activate the heating elements. Positioning of the device, cutting, and cauterization are performed under endoscopic visualization. This device is intended for specific use with the Vasoview Hemopro Power Supply and Vasoview Hemopro 3 Power Adapter.
MAQUET CARDIOVASCULAR LLC
VH-6020
Not in Commercial Distribution

  • 00607567701298 ()
VH-6020

  • Flexible endoscopic scissors, reusable
The Vasoview Hemopro 3 Endoscopic Vessel Harvesting System is designed for use in conjunction with the 7 mm Endoscope. The Harvesting Cannula has four lumens which house the Endoscope, C-Ring, distal lens washer tube and Vasoview Hemopro 3 Harvesting Tool for cutting and cauterization of vessel branches. The C-Ring with the built-in distal lens washer is independently controlled by a C-Ring Slider on the handle of the Harvesting Cannula. The C-Ring cradles the vessel and delivers the saline that washes the distal tip of the Endoscope. The Harvesting Tool can be inserted, removed, rotated, extended, and retracted from the main Harvesting Cannula through the Tool Adapter Port. The Harvesting Tool is powered by direct current (DC) only; it does not utilize RF (radio frequency) energy. The Harvesting Tool cuts and cauterizes through a process of heat and pressure. The Harvesting Tool has two curved Jaws. One of the Jaws contains the heating elements for branch cutting and cauterization and spot cautery. There are three heating elements: two cauterization elements and a cutting element between them. Both Jaws have insulation protecting the adjacent tissue. The concave side of the Jaws has a larger buffer of insulation and therefore should be positioned toward sensitive tissue during Jaw activation. An area near the tip of the convex side of the Jaw can be used for spot cautery to cauterize tissue contacted by that area of the Jaw. The Activation Toggle is used to control the Jaws and to activate the heating elements. Positioning of the device, cutting, and cauterization are performed under endoscopic visualization. This device is intended for specific use with the Vasoview Hemopro Power Supply and Vasoview Hemopro 3 Power Adapter.
MAQUET CARDIOVASCULAR LLC
VH-6000
In Commercial Distribution

  • 00607567701274 ()
VH-6000

  • Flexible endoscopic scissors, reusable
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