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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Spinous Process Fusion Plate
Pioneer Surgical Technology, Inc.
83-00-10
Not in Commercial Distribution

83-00-10

  • Spinal fixation plate, non-bioabsorbable
Spinous Process Fusion Plate
Pioneer Surgical Technology, Inc.
83-00-08
Not in Commercial Distribution

83-00-08

  • Spinal fixation plate, non-bioabsorbable
No Description
SPECTRUM MEDICAL SRL
SPC-160R
In Commercial Distribution

  • 28051160302530 ()


  • Cardiopulmonary bypass system blood tubing set
No Description
SPECTRUM MEDICAL SRL
SPC-200R
In Commercial Distribution

  • 28051160302509 ()


  • Cardiopulmonary bypass system blood tubing set
No Description
SPECTRUM MEDICAL SRL
SPC-160
Not in Commercial Distribution

  • 28051160302479 ()


  • Cardiopulmonary bypass system blood tubing set
No Description
SPECTRUM MEDICAL SRL
SPC-200
Not in Commercial Distribution

  • 28051160302462 ()


  • Cardiopulmonary bypass system blood tubing set
No Description
SPECTRUM MEDICAL SRL
CP20V-V0U
In Commercial Distribution

  • 18051160302144 ()


  • Cardiopulmonary bypass system centrifugal pump
No Description
SPECTRUM MEDICAL SRL
SP05E-AA
In Commercial Distribution

  • 18051160302717 ()


  • Cardiopulmonary bypass system blood tubing set
No Description
SPECTRUM MEDICAL SRL
DL31F-V1
In Commercial Distribution

  • 18051160302694 ()


  • Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, drainage
No Description
Starkey Laboratories, Inc.
EVOLV AI CIC
In Commercial Distribution

  • 00842318189738 ()


  • Tinnitus masking application software
  • Air-conduction hearing aid, canal
Sunquest Application Interface (AI) is to provide interfaces between client systems and Sunquest products to support laboratories in the management of laboratory workflow (order entry through reporting) and transfer test results and information
CliniSys, Inc
5.3
Not in Commercial Distribution

  • B236AI5300 ()


  • Clinical laboratory information system application software
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
No Description
SPECTRUM MEDICAL SRL
CONN-HX2
In Commercial Distribution

  • 08051160301577 ()


  • Cardiopulmonary bypass system heat exchanger, single-use
No Description
SPECTRUM MEDICAL SRL
CONN-HX1
In Commercial Distribution

  • 08051160301560 ()


  • Cardiopulmonary bypass system heat exchanger, single-use
No Description
SPECTRUM MEDICAL SRL
CGSP2-P1
Not in Commercial Distribution

  • 08051160301386 ()


  • Cardioplegia solution administration kit
No Description
SPECTRUM MEDICAL SRL
CGSP2-P0
Not in Commercial Distribution

  • 08051160301379 ()


  • Cardioplegia solution administration kit
No Description
SPECTRUM MEDICAL SRL
CGSP7-B0
Not in Commercial Distribution

  • 18051160302793 ()


  • Cardioplegia solution administration kit
No Description
SPECTRUM MEDICAL SRL
CGSP6-B0
Not in Commercial Distribution

  • 18051160302786 ()


  • Cardioplegia solution administration kit
The Lifewarmer Quantum Blood and Fluid Warming System is a Game-Changing innovation that has succeeded in closing a critical capability gap previously left exposed by other commercial off-the-shelf fluid warmers currently fielded. Size, weight, performance, and ease of use are no longer collective barriers to the delivery of whole blood in far forward and near point of injury (POI) prehospital casualty management. The Quantum exceeds all healthcare and logistical requirements for the delivery of warmed blood or fluids across the defined spectrum of care. The system consists of unique thermal administration sets that incorporate sensing elements with an integrated heating system that does not disrupt the fluid path. With advanced intelligence throughout the system, the lightweight Controller modulates and moderates the energy flow to the integrated heating elements to ensure consistent normothermic fluid delivery to the casualty. The 44V battery is the smallest in category, able to rapidly adjust power distribution based on the temperature and flow rate of the input fluid. This creates a highly efficient system capable of previously unrealized performance optimizations. The Quantum system has an operational weight of just 22 total ounces yet can deliver two units of 39°F Whole Blood (WB) at 100mL/min with an output temperature of 100.4°F (38°+/- 2°C) with only a 24 second warm-up period. The Quantum Blood and Fluid Warming System provides the Tactical Health Care Professional with significant technological overmatch in the fight to eliminate preventable combat death. Quantum System Contents: 1 x Controller 1 x Battery 1 x Battery Charger 2 x TTS-B (Thermal Transfusion Set - Blood) NOTE: TTS-B is Single Use Only, Supplied sterile via Ethylene Oxide
NORTH AMERICAN RESCUE, LLC
63-5900
In Commercial Distribution

  • 00868058000485 ()
35-0006

  • Conduction blood/fluid warmer
No Description
SPECTRUM MEDICAL SRL
VT160-C2U
In Commercial Distribution

  • 08051160301454 ()


  • Extracorporeal membrane oxygenator
No Description
SPECTRUM MEDICAL SRL
VT200-C2U
In Commercial Distribution

  • 08051160301430 ()


  • Extracorporeal membrane oxygenator
No Description
SPECTRUM MEDICAL SRL
VT160-C2
In Commercial Distribution

  • 08051160300761 ()


  • Extracorporeal membrane oxygenator
No Description
SPECTRUM MEDICAL SRL
VT200-C2
In Commercial Distribution

  • 08051160300709 ()


  • Extracorporeal membrane oxygenator
BOTTOM TRAY
Pioneer Surgical Technology, Inc.
430-162
Not in Commercial Distribution

  • 00846468041816 ()
430-162

  • Device sterilization/disinfection container, reusable
MIDDLE TRAY
Pioneer Surgical Technology, Inc.
430-161
Not in Commercial Distribution

  • 00846468041809 ()
430-161

  • Device sterilization/disinfection container, reusable
TOP TRAY
Pioneer Surgical Technology, Inc.
430-160
Not in Commercial Distribution

  • 00846468041793 ()
430-160

  • Device sterilization/disinfection container, reusable
10mm Rasp
Pioneer Surgical Technology, Inc.
83-RASP-10
Not in Commercial Distribution

  • 00846468047849 ()
83-RASP-10

  • Bone file/rasp, manual, reusable
8mm Rasp
Pioneer Surgical Technology, Inc.
83-RASP-08
Not in Commercial Distribution

  • 00846468047832 ()
83-RASP-08

  • Bone file/rasp, manual, reusable
Lock Plate Inserter
Pioneer Surgical Technology, Inc.
83-L-INSERTER
Not in Commercial Distribution

  • 00846468047825 ()
83-L-INSERTER

  • General internal orthopaedic fixation system implantation kit
Compressor
Pioneer Surgical Technology, Inc.
83-L-COMPRESSOR
Not in Commercial Distribution

  • 00846468047818 ()
83-L-COMPRESSOR

  • General internal orthopaedic fixation system implantation kit
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