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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COE® ADHESIVE Bulk Bottles (Set of 12), 13mL
Gc America Inc.
133912
In Commercial Distribution

  • D6581339121 ()
133912

  • Pharmaceutical fluid-dispensing system
A mains electricity (AC-powered) hard-shelled vessel (e.g., metal, acrylic) in which a patient is placed to receive hyperbaric oxygen therapy (HBOT), the medical use of oxygen (O2) at a higher than atmospheric pressure. The device increases environmental O2 pressure above normal to promote movement of O2 into a patient's tissues. It typically includes an airlock(s) for patient/object entry, view ports, air valves, and a control panel. It is used to treat disorders that typically include decompression sickness, carbon monoxide poisoning, air/gas embolism, necrotizing tissue infections, and various injuries/wounds; it can also be used to study effects of pressure and decompression.
FINK ENGINEERING PTY LTD
TL20
In Commercial Distribution

  • B718TL20287CM090 ()
TL20287CM09

  • Hyperbaric chamber, stationary
A mains electricity (AC-powered) hard-shelled vessel (e.g., metal, acrylic) in which a patient is placed to receive hyperbaric oxygen therapy (HBOT), the medical use of oxygen (O2) at a higher than atmospheric pressure. The device increases environmental O2 pressure above normal to promote movement of O2 into a patient's tissues. It typically includes an airlock(s) for patient/object entry, view ports, air valves, and a control panel. It is used to treat disorders that typically include decompression sickness, carbon monoxide poisoning, air/gas embolism, necrotizing tissue infections, and various injuries/wounds; it can also be used to study effects of pressure and decompression.
FINK ENGINEERING PTY LTD
TL20
In Commercial Distribution

  • B718TL20287CM060 ()
TL20287CM06

  • Hyperbaric chamber, stationary
A mains electricity (AC-powered) hard-shelled vessel (e.g., metal, acrylic) in which a patient is placed to receive hyperbaric oxygen therapy (HBOT), the medical use of oxygen (O2) at a higher than atmospheric pressure. The device increases environmental O2 pressure above normal to promote movement of O2 into a patient's tissues. It typically includes an airlock(s) for patient/object entry, view ports, air valves, and a control panel. It is used to treat disorders that typically include decompression sickness, carbon monoxide poisoning, air/gas embolism, necrotizing tissue infections, and various injuries/wounds; it can also be used to study effects of pressure and decompression.
FINK ENGINEERING PTY LTD
DL8
In Commercial Distribution

  • B718DL82130 ()
DL8213

  • Hyperbaric chamber, stationary
A mains electricity (AC-powered) hard-shelled vessel (e.g., metal, acrylic) in which a patient is placed to receive hyperbaric oxygen therapy (HBOT), the medical use of oxygen (O2) at a higher than atmospheric pressure. The device increases environmental O2 pressure above normal to promote movement of O2 into a patient's tissues. It typically includes an airlock(s) for patient/object entry, view ports, air valves, and a control panel. It is used to treat disorders that typically include decompression sickness, carbon monoxide poisoning, air/gas embolism, necrotizing tissue infections, and various injuries/wounds; it can also be used to study effects of pressure and decompression.
FINK ENGINEERING PTY LTD
DL8
In Commercial Distribution

  • B718DL82030 ()
DL8203

  • Hyperbaric chamber, stationary
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
COMPACT CONTROL, PANEL MOUNT, 2 HP AUTO, MCC
Ls Enterprises, Inc.
2520MCC-G
In Commercial Distribution

  • D0692520MCCG0 ()


  • Dental delivery system
COMPACT CONTROL, PANEL MOUNT, 2 HP AUTO, MCC
Ls Enterprises, Inc.
2520MCC
In Commercial Distribution

  • D0692520MCC0 ()


  • Dental delivery system
DUO UNIT, LEFT/RIGHT, UNDER WORKSURFACE PANEL CONTROL
Ls Enterprises, Inc.
2186
In Commercial Distribution

  • D06921860 ()


  • Dental delivery system
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