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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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GC CARTRIDGE DISPENSER II 48mL
Gc America Inc.
152101
In Commercial Distribution

  • D6581521011 ()
152101

  • Pharmaceutical fluid-dispensing system
PLUNGER FOR UNIVERSAL DISPENSER
Gc America Inc.
152081
In Commercial Distribution

  • D6581520811 ()
152081

  • Pharmaceutical fluid-dispensing system
100 INTRAORAL TIPS UNIVERSAL/NDS
Gc America Inc.
150100
In Commercial Distribution

  • D6581501001 ()
  • D6581501000 ()
150100

  • Pharmaceutical fluid-dispensing system
COE® ADHESIVE Bulk Bottles (Set of 12), 13mL
Gc America Inc.
133912
In Commercial Distribution

  • D6581339121 ()
133912

  • Pharmaceutical fluid-dispensing system
COE® ADHESIVE BOTTLE ONLY, 13mL
Gc America Inc.
133911
In Commercial Distribution

  • D6581339111 ()
133911

  • Pharmaceutical fluid-dispensing system
The PAH-SI Hyperbaric Chamber System is a Class B monoplace hyperbaric chamber designed to treat one patient at up to a maximum operating pressure of 3 Atmospheres Absolute (ATA) or 29.4 pounds per square inch gauge (psig). The chamber uses 100% oxygen as the pressurization gas and patient breathes the oxygen contained inside the chamber as the hyperbaric treatment gas.
PAN-AMERICA HYPERBARICS INC.
PAH-S1
In Commercial Distribution

  • 04719872000013 ()

  • Max. Operating Pressure: 29.4 psig/3 ATA


  • Hyperbaric chamber, stationary
Digital Radiography Sensor
RF CO.,LTD.
XM
In Commercial Distribution

  • 04582384740025 ()


  • Diagnostic x-ray digital imaging conversion system
Digital Radiography Sensor
RF CO.,LTD.
XM
In Commercial Distribution

  • 04582384740018 ()


  • Diagnostic x-ray digital imaging conversion system
Hyperbaric Chamber
Hyperbaric For Life.com, Llc
8003
In Commercial Distribution

  • G625R800340 ()


  • Hyperbaric chamber, stationary
The Portable Hyperbaric Chamber Revitalair® 430+ is a hyperbaric semi-rigid chamber for low pressures (operating at pressures of no greater than 1.5 atmospheres absolute (ATA)). The operational design pressure of a hyperbaric chamber that encloses a human within its pressure boundary falls within the scope of the American Society of Mechanical Engineers Pressure Vessels Human Occupancy 1 (ASME PVHO 1-2012).
US Hyperbaric Network LLC
430+
In Commercial Distribution

  • G623430 ()


  • Hyperbaric chamber, stationary
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